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Montefiore Medical Center Experience (1987 to 2003)
Gynecologic Oncology 101 (2006) 261 – 268 www.elsevier.com/locate/ygyno
Total pelvic exenteration: The Albert Einstein College of Medicine/Montefiore Medical Center Experience (1987 to 2003)i Gary L. Goldberg *, Paniti Sukumvanich, Mark H. Einstein, Harriet O. Smith, Patrick S. Anderson, Abbie L. Fields Division of Gynecologic Oncology, Department of Obstetrics and Gynecology and Women’s Health, Albert Einstein College of Medicine and Montefiore Medical Center, 1825 Eastchester Road-Room 722, Bronx, NY 10461, USA Received 26 May 2005 Available online 19 January 2006
Abstract Objective. To review the trends, modifications and results of 103 consecutive total pelvic exenterations (TPE) performed at the Montefiore Medical Center and Albert Einstein College of Medicine from 1987 to 2003. Methods. All patients who underwent TPE from January 1987 to December 2003 were included. The medical record, complications, followup, clinical status and demographic information were entered in a database. The procedure performed, the method of urinary diversion, colonic diversion, pelvic floor support and vaginal reconstruction were documented. Surviving patients were surveyed regarding their satisfaction with the urinary diversion, the vaginal reconstruction and their sexual function since the surgery. Results. 103 pts were identified. Indications for TPE were recurrent cancers of the cervix (95), endometrium (2), colon and rectum (5), vulva (1). Overall 5-year survival was 47%. 5-year survival for pts with recurrent cervix cancer was 48%. Six pts (6%) recurred >5 years after the TPE. 14 pts (14%) had ureteral anastomotic leaks (no difference between ileal conduit 9/65 (14%) versus 5/38 (13%) continent conduit ( P = 0.92). 34 pts (89%) with continent conduits were ‘‘continent.’’ 14 pts (17%) had wound complications. 4 pts (4%) had parastomal hernias. 5/11 (46%) pts who had a low rectal reanastomosis developed recurrence in the pelvis. 21/39 (54%) of pts with continent conduits would choose an ileal conduit if they had the option again. Long-term renal function was similar in pts with ileal and continent conduits. Mesh of any type for pelvic floor reconstruction is associated with infection and bowel/urinary fistulas. VRAM flaps for neovagina fill the pelvic dead space, reduce the risk of fistulas and 20/36 pts (55%) are sexually active. Conclusions. Our overall 5-year survival is encouraging, and modifications in surgical technique have improved the reconstructive phase. Low rectal anastomoses at TPE adversely affects survival. Many of our pts with continent urinary diversions would not choose this method again. Mesh of any type is associated with sepsis and bowel/urinary fistulas. VRAM for neovagina reduces fistula rate and are functional in >55% of pts. TPE remains a potentially curative option for these pts. D 2005 Elsevier Inc. All rights reserved. Keywords: Total pelvic exenteration; Complications; Urinary diversion; Recurrent cervical cancer; Cancer
Introduction Over 50 years ago, pelvic exenteration was first described by Brunschwig and colleagues from the Memorial Hospital in New York [1]. Initially, pelvic exenteration was utilized for the palliative surgical management of advanced and recurrent gynecologic cancers but, over the next 10 –15 years, evolved i
Presented in part at the annual Society of Gynecologic Oncologists Meeting in Miami in March 2005. * Corresponding author. Fax: +1 718 904 2774. E-mail address: [email protected] (G.L. Goldberg). 0090-8258/$ - see front matter D 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.ygyno.2005.10.011
into a curative intervention for advanced and recurrent gynecologic cancers confined to the central pelvis [2,3]. The extent of the surgical procedure required has been adapted to the site and location of the recurrent or residual disease. Total pelvic exenteration (TPE) entails the en bloc resection of the pelvic viscera in both the anterior and posterior urogenital compartments and is the only available procedure for extensive tumors of the cervix, uterus, vagina, vulva, colon (usually recto-sigmoid), bladder, urethra and occasionally ovary [4– 6]. Currently, the primary role of TPE is for the treatment of cancers of the cervix that recur in the central pelvis following
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radiation therapy with or without chemotherapy in patients with no evidence of occult metastatic disease outside the pelvis. Although the incidence of advanced stage cervical cancer appears to be declining in many developed countries, it remains a significant problem for women in developing and third world countries [7 –11]. It is a major health care issue in South America (and other developing and third world countries) where it is still the most common cancer in women [9]. There have been numerous reports describing the surgical procedure, technique and the outcome from numerous prestigious institutions around the world [5,6,12 –19]. The patient selection criteria, peri-operative preparation and post-operative care have changed significantly over the past two decades. The surgical procedure has evolved from a purely extirpative/ exenterative one to an operation that includes a reconstructive phase which has assumed even greater importance in recent years with refinements in urinary diversion, colon sparing surgery, preservation of the anal sphincter and vaginal and pelvic floor reconstruction. In keeping with other large academic medical centers, we have made significant modifications to our surgical techniques for both the extirpative and the reconstructive phases of the total pelvic exenteration procedure at the Albert Einstein College of Medicine and Montefiore Medical Center over the past 18 years. We have previously published a series of patients where we described the risk factors for poor prognosis at the time of TPE and those patients who might benefit from intraoperative or post-operative brachytherapy [20]. We have also reported on the modifications, complications and sexual function with regard to vaginal reconstruction using the Vertical Rectus Abdominis Myocutaneous (VRAM) flap at the time of TPE [21]. The majority of the alterations and modifications to the surgical procedures at TPE described in this report were initiated and performed by the primary author (GLG). Materials and methods After IRB approval (protocol #04-01-011E), there was a systematic review of in-patient and out-patient medical records from all patients who underwent TPE on the gynecologic oncology service at the Albert Einstein College of Medicine/Montefiore Medical Center from January 1987 to December 2003. Pts who underwent an anterior exenteration only or a posterior exenteration only were excluded from this analysis. A database was developed abstracting the predetermined variables of interest from the operative report, pathology reports, peri-operative studies, hospital course, duration of hospital stay, readmissions, operative and long-term complications, and disease status as of December 2003. Demographic information includes age, race, date of diagnosis, initial FIGO stage, date of TPE, histology, prior therapy including radiation therapy and/or chemotherapy. Other data extracted included the routine pre-operative and postoperative testing, CT scan/MRI, bone scan and renal scans. The types of surgical procedures performed, including the method of urinary diversion, colonic diversion, pelvic floor support and vaginal reconstruction was documented. Surviving patients were surveyed regarding their satisfaction with the vaginal reconstruction and their sexual function after the surgery. However, there was no baseline information for these patients regarding their sexual activity/function prior to the TPE. Thus, we were unable to compare their sexual activity pre- and post-TPE. This is a continuation of the initial patients reported by our group in 1998 [21].
Patients with continent urinary diversion were also questioned regarding their satisfaction with the procedure and related issues. The patients were questioned regarding their satisfaction with the results, specifically, urinary continence, absence of a bag/appliance, convenience and/or interference with their activities of daily living and whether they would choose a continent diversion again or an ileal conduit with a bag if they had to undergo the procedure again. Renal function was tested pre-operatively and post-operatively in all patients including blood chemistry, IVP or CT scan as clinically indicated. There was annual evaluation of the renal tract in the surviving patients with documentation of the results. Patients were followed in the office every 3 months for the first 2 years, then every 6 months until the fifth year and then annually thereafter. The surgical techniques used for the vaginal reconstruction [21], urinary diversion (ileal conduit or continent conduit [22 – 25] and low rectal anastomosis [26,27] have all been previously reported. Modifications unique to the Albert Einstein College of Medicine/Montefiore Medical Center experience will be presented. Statistical analysis, where appropriate, included Chi-square and Fischer’s Exact test.
Results Between 1987 and 2003, TPE was performed on 103 patients. We have follow-up information on all the patients in this group. Additional demographic characteristics are shown in Table 1. The mean age was 52.7 years (range 24 –81 years). The race and ethnic distribution was as follows: Caucasian (36%), Hispanic White (34%), African American (26%) and Asian – South Island/Pacific (4%). The majority of the patients (95) underwent the procedure for recurrent cervical cancer, 2 for recurrent endometrial cancer, 5 for persistent recto-sigmoid cancer after radiation and chemotherapy and 1 for recurrent vulva cancer (see Table 2). All the patients received pelvic radiation therapy prior to the TPE. Some patients had received extended radiation fields and brachytherapy, in addition to the pelvic radiation. Fifty-three patients (51%) received chemotherapy in addition to or concomitant with the radiation therapy and 50 patients (49%) received radiation therapy alone. Of the 95 patients with cervix cancer, the histo-pathology at the time of their diagnosis was that 75 (79%) had squamous cell carcinoma, 18 (19%) had adenocarcinoma and 2 (2%) had adenosquamous carcinoma. There was one peri-operative mortality in our series of patients. This patient expired on the 48th post-operative day
Table 1 Patient demographics #
(%)
(n = 103) Race AfricanAmerican Hispanic Caucasian Asian
27 35 37 4
26 34 36 4
Histology Squamous Adenocarcinoma Adenosquamous
76 25 2
74 24 2
Prior treatment Chemo/RT RT only
53 50
51 49
G.L. Goldberg et al. / Gynecologic Oncology 101 (2006) 261 – 268 Table 2 Primary cancer site Cervical cancer Endometrial cancer Colon cancer Vulva cancer
95 2 5 1
from possible sepsis related to a ureteral anastomotic leak. A pulmonary embolus could not be excluded as the patient’s family refused an autopsy to further clarify the cause of death. Another patient died >90 days post-operatively from sepsis, probably related to the mesh used for the pelvic floor. There were no intra-operative or immediate post-operative deaths in our series of patients. Thus, the immediate peri-operative survival rate in this group of patients was 98%. Complications As illustrated in Table 3, the majority of patients had febrile morbidity (71%). Urinary tract infections were documented in 37 patients. Of these 37 patients, 29 had continent urinary diversions and 8 had ileal conduits. Urinary tract infection/ pyelonephritis appears to be more common after TPE in those patients with continent conduits ( P < 0.001). Six patients with continent conduits (16%) had persistent difficulty with selfcatheterization despite adequate initial training and supervision in performing the procedure. Fourteen patients (14%) developed ureteral anastomotic leaks after the TPE. There was no significant difference in the incidence of ureteral anastomotic leaks between the ileal conduit group (9/65, 14%) and the continent conduit group (5/38, 13%, P = 0.92). 12/14 pts with ureteral leaks were in those who had a mesh placed to cover the denuded pelvic floor. The most common co-factor associated with an anastomotic leak was the use of mesh, irrespective of the type of mesh used. In order to perform the low rectal anastomosis and for the patient to have fecal continence, you require at least 4– 5 cm of rectum, and this means resection at the time of exenteration at/or very close to the original tumor or the site of the initial pelvic recurrence. We strongly believe that this affects the patients overall survival. Table 3 Complications Complication
#
(%)
Febrile morbidity UTI/Pyelonephritis Wound complications Difficulty with self catheterization Ureteral/Anastomotic leaks GI fistulas Pouch incontinence Small bowel obstruction Thromboembolic complications Ureteral stricture Stomal stricture Parastomal hernia Pouch fistula Urinary stones Mortality
73/103 37/103 17/103 6/38 14/103 11/103 4/38 9/103 7/103 5/103 4/103 4/103 1/38 2/103 1/103
71 36 17 16 14 11 11 9 7 5 4 4 3 2 1
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Eleven patients developed sepsis associated with the mesh that was used for the pelvic floor, and three of these subsequently developed entero-cutaneous or entero-perineal fistulas. Based on the current literature regarding the risk for symptomatic deep venous thrombosis [28], this complication was much lower than clinically anticipated. Four patients (3.9%) developed symptomatic deep venous thromboses postoperatively requiring anticoagulation. All four patients received anticoagulant therapy and in our series, there were no documented pulmonary emboli. The absolute number of pts who developed DVT in this series is unknown as they were not tested for unless clinically indicated. Seven patients had rectoperineal fistulas (excluding the 4 fistulas following low rectal anastomosis), and one patient had a urinary pouch-cutaneous fistula from a continent conduit. There were no entero- or colocutaneous or perineal fistulas in our patients who had a VRAM flap. The VRAM appears to fill the dead space in the pelvic cavity, and the radiated small bowel does not become adherent to the mesh or the denuded pelvic floor which increases the likelihood of a fistula. There were 4 patients (4%) who developed parastomal hernias at their colostomy sites. These patients were all managed conservatively. Wound complications occurred in 14 patients (17%). None of the patients had a wound dehiscence. Three patients required mesh to close the abdominal wall – all following a VRAM flap – 2 of these developed seromas with separation of the wound. The rest of the wound complications were varying degrees of wound infection and/or separation. None of these patients required surgical intervention for the wound complications. Urinary diversion Sixty-five patients (63%) had an ileal conduit and 39 patients (37%) had a continent urinary diversion. Initially, we used a modification of the ‘‘Indiana’’ pouch [29] and subsequently our own modifications of the ‘‘Miami’’ pouch [24,25] (Table 4). Fourteen patients had ureteral anastomotic leaks (14%). Four of these 14 patients required surgical correction despite initial conservative management. The other 10 patients (71%) were managed conservatively. Five patients developed ureteral strictures. Three of the 5 patients with ureteral strictures occurred in patients with a continent conduit and in 2 patients with an ileal conduit. This was not statistically significant ( P = 0.4). All the strictures were managed conservatively. No ureteral strictures occurred Table 4 Urinary diversion/low rectal anastomosis Type
#
(%)
Urinary diversion Ileal conduit Continent conduit
65 38
63 37
Low rectal reanastomosis Total Recurrent disease in pelvis Fistulas
11 5 4
45 36
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in our patients with continent conduits after we changed our method of ureteral implantation into the conduit. Initially, we used a technique of tunneling the implanted ureter through the tenia of the cecum and/or ascending colon (the reservoir). Subsequently, we have changed to direct ureteral implantation without any tunneling of the ureter. Two patients with continent conduits developed urinary stones in the conduit. Both patients had their calculi managed as outpatients. Thirtyfour patients (89%) with the continent conduit were actually continent of urine. Four patients were incontinent of urine, and all 4 have refused revision of the pouch or any other invasive intervention. These 4 patients were managed with indwelling foley-type sialastic catheters and a urostomy bag to control the urinary incontinence. There was one patient who developed a continent conduit-cutaneous fistula. This patient required surgical correction of the fistula and revision of the pouch. The renal function in patients who were clinically free of disease remained normal post-operatively with both the ileal conduit and the continent conduit. All these surviving patients displayed mild to moderate hydronephrosis on IVP and/or CT scan without evidence of obstruction or altered renal function by chemistry and/or renal perfusion scan when clinically indicated. The most common admission diagnosis was for urinary tract infections/pyelonephritis. This appeared to be more common in patients with continent conduits especially where there was difficulty with self-catheterization. Four patients (10%) with a continent conduit developed stomal stricture or stenosis. This required active intervention with stomal dilation on a regular basis. None of these patients has required surgical intervention, and one patient has had the conduit for >8 years. Twenty-one patients (54%) reported difficulty and/or annoyance with self-catheterization, problems and/or difficulty in with dealing with self-catheterization at night. All of these 21 patients expressed the opinion that they would undoubtedly have chosen an ileal conduit with a bag if they had the option again and needed to have the procedure repeated. Low rectal anastomosis Consistent with early reports in the literature [26,27], we started offering our patients with recurrent disease that appeared to be localized anterior recurrences, the option of low rectal anastomosis with conservation of the rectum and anus at the time of TPE (Table 4). Five of 11 patients (45%) with negative surgical margins and lymph nodes at the time of the TPE had early recurrent disease in the pelvis at or near the site of the rectal anastomosis. There were 4 (36%) recto-perineal fistulas in this group. Three of the 4 patients developed fistulas secondary to disease recurrence at the site of the anastomosis. We did not perform diverting colostomies in our patients undergoing low rectal anastomosis. We have abandoned the surgical option of low rectal anastomosis after our first 11 patients due to the high recurrence rate in the pelvis after these rectal sparing procedures and in our opinion, we believe it compromises the patient’s chance of long-term survival.
Vaginal reconstruction Forty-eight patients (47%) had vaginal reconstruction at the time of the TPE. Three patients (6%) had omentum/colon neovaginas, 9 (19%) had split thickness skin grafts (McIndoe type) and 36 (75%) had Vertical Rectus Abdominis Myocutaneous (VRAM) flaps. Our initial series VRAM flaps at the time of TPE was reported by Smith et al. in 1998 [21]. Additional 20 cases have been performed since that report and the overall results and outcome are similar. The anatomic restoration is excellent, and the graft fills the entire dead space in the pelvic cavity. There were no graft rejections in our series at Einstein/ Montefiore. There were 4 patients with partial necrosis of the VRAM neovagina. Three of these 4 patients were managed conservatively with eventual healing and one patient required surgical revision with an excellent result. The patients with the VRAM report sexual function in >50% of cases (see Table 5). Pelvic floor reconstruction We have utilized many different techniques and materials in order to cover and fill the denuded pelvis and dead space at the time of TPE. Initially, we used an omental sling or pedicle graft, and later, we tried different types of mesh to act as a sling and to cover the denuded pelvic cavity. It did not matter whether we used absorbable mesh (Vicryl), non-absorbable mesh (Prolene), allografts and other materials such as bovine pericardium, we experienced a high rate of enteric/ureteral anastomotic fistulas and sepsis related to these materials. Entero-cutaneous, entero-perineal fistulas and small bowel and ureteral anastomotic leaks were associated with the mesh or other foreign material. This occurred despite the use of omentum sutured over to cover the top of the mesh. With regard to the use of foreign graft material for pelvic floor reconstruction: the highest rate of small bowel fistulas and/or ureteral anastomotic leaks occurred in patients where Table 5 Neovagina
Neovagina Total Omentum/Colon McIndoe/Split-Thickness skin graft VRAM flap
#
(%)
48/103 3/48 9/48 36/48
47 6 19 75
# of pts
NED
DOD
18 3
2 13
VRAM Flap/Neovagina and sexual function Total 36 Sexually active 20 (56) Not sexually active 16 (45) # Satisfaction with VRAM flap/neovagina (N = 20) Very satisfied 5 Satisfied 12 Somewhat satisfied 3 Not satisfied 0
(%) 25 60 15
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these materials were used. We had a total of 14 ureteral anastomotic leaks and 11 GI fistulas. Of the 14 ureteral anstomotic leaks, 12 were in patients with a foreign graft and of the 11 GI fistulae, 6 had foreign material grafts. All of these 6 patients with GI fistulas had ureteral anstomotic leaks as well. Of the total leaks and fistulas, 18 of the 25 were associated with foreign material grafts. We have had no GI fistulas or ureteral anastomotic leaks to date where the pelvic cavity is ‘‘filled’’ with the rectus myocutaneous graft. Survival The 5-year survival for all our patients following TPE is 47% (Table 6). The overall survival rate for patients who are alive at 5 years is 87%. Six patients have developed recurrent disease more than 5 years after the TPE. Two of these 6 patients developed lung metastases diagnosed at 7 and 8 years after the TPE, respectively. Three of the 6 patients were diagnosed with enlarged paraaortic nodes at 6, 8, and 12 years respectively after the TPE. One of the 6 patients was diagnosed with liver metastases 7 years after the surgery. Overall 42 patients (41%) are clinically without evidence of disease, and 2 patients (2%) are alive with disease. Fifty-four patients (52%) are dead of the disease, and 5 patients (5%) have died from other causes including, myocardial infarction (3), stroke (1), motor vehicle accident (1). Of the 5 patients who have died of other causes, 2 were clinically without evidence of disease at 5 years. The 5-year survival rate for the 95 patients who had the TPE for recurrent cervix cancer is 48% (46/95). There were 25 patients with adenocarcinoma in this group, 5 of the 25 had adenocarcinoma of the rectosigmoid, 2 of the 25 had adenocarcinoma of the endometrium and 18 had adenocarcinoma of the cervix. There was no difference in the 5-year survival for patients with adenocarcinoma of the cervix 6/18 (33%) versus 41/77 (53%) patients with squamous cell carcinoma of the cervix ( P = 0.13). The most common admission diagnosis was for urinary tract infections/pyelonephritis. This appeared to be more common in patients with continent conduits especially where there was difficulty with self-catheterization.
Table 6 Disease status/survival
NED AWD DOD DOC 5-year survival—all patients >5-year survival—all patients 5-year survival—cervix cancer patients only >5-year survival—cervix cancer patients only Dead >5 years Lung metastases Paraaortic nodes Liver metastases
#
(%)
42 2 54 5 48 42 46/95 40/95 6 2 3 1
41 2 53 5 47 41 48 42 (at 7, 8 years) (at 6, 8, 12 years) (at 7 years)
NED—no evidence of disease; DOD—dead of disease; AWD—alive with disease; DOC—dead of other causes.
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Comment We have made a number of significant modifications to the TPE procedure over the past 18 years at the Albert Einstein College of Medicine/Montefiore Medical Center. We do not rely on examination under anesthesia, CT scan or MRI reports to determine whether our patients are eligible candidates for TPE. We offer the patient the option of an exploratory laparotomy to determine whether they are eligible or ineligible for the procedure. We generally do not perform palliative TPE and will usually abort the procedure if the lymph nodes are positive or if the tumor is not resectable from the pelvic sidewall with grossly clear surgical margins. In view of some reports in the literature we have completed the TPE in 3 patients with positive pelvic node/s. Two of the 3 patients are dead of disease in less than 1 year, and one patient is alive and clinically without evidence of disease at 11 months. This patient received intra-operative placement of brachytherapy after complete resection of the nodes [19,30]. Our group previously reported the risk factors for recurrence at the time of TPE and those patients who we believe might benefit from intra- or post-operative brachytherapy [20]. We have modified our technique of continent urinary diversion procedures in the following ways. We no longer use separate independent drainage of the conduit with a Mallinckrodt\ (Chicago, IL) or other drain. This was associated with a pouch-cutaneous fistula that required surgical revision and does not appear to reduce the complications. We have altered our method of ureteral implantation into the pouch from tunneling the ureter through the tenia of the colon to direct implantation of the ureter in the conduit without tunneling. Difficulty with self-catheterization was more common in our initial series of patients undergoing continent urinary diversion as we made the ileal portion of the conduits too long. The ileal segment then tended to become tortuous. Together with the tapering of the ileal segment and the ileo-cecal valve, this resulted in patients experiencing difficulty with self-catheterization. We subsequently have made the ileal segment shorter, and we now attach the pouch with sutures to the anterior abdominal wall. Both of these modifications have resulted in fewer patients experiencing difficulty with self-catheterization without affecting the continence of the urinary diversion. We have shortened the length of the ileal portion used for the stoma and taper this according to the body habitus of the patient and the state of the blood supply of the small bowel being utilized. We anchor the conduit to the anterior abdominal wall to try to prevent ureteral anastomotic leaks and other fistulae by reducing the risk of the conduit becoming adherent to the denuded pelvic floor. We discussed the option and performed low rectal anastomoses in eligible patients who elected to have a continent urinary diversion. This allowed these patients the opportunity to have no external stomal hardware, appliances or bags. The anastomotic breakdown and fistula rate for our patients undergoing low rectal anastomosis were similar to that reported by others [24,26]. Due to the high rate of early tumor recurrence
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at or near the site of the primary low rectal anastomosis in our initial series of 11 patients, we no longer offer our patients the choice of a low rectal anastomosis at the time of TPE. We believe it compromises their chances of survival. We have stopped using synthetic or other materials to fill the dead space and cover the denuded pelvic floor at the time of TPE. In our experience, the VRAM flap is the most effective method to fill the dead space. It also appears to be the most effective method of vaginal reconstruction at the time of the TPE. The VRAM flap fills the dead space very effectively and is less likely to be associated with any form of GI fistula. It is highly effective for the creation of a neovagina, and our results to date are excellent with regard to restoration of a potentially functional neovagina. Graft rejection has not been a problem in our series of 36 patients to date. The blood supply to the flap is easily identifiable and can be protected throughout the procedure so that the risk of graft necrosis and graft rejection is diminished or avoided. There was a ‘‘learning curve’’ when we initiated continent urinary diversion and VRAM flaps as part of the reconstructive phase of the TPE procedure. Our institution is an academic teaching hospital, and we have the responsibility for training fellows in gynecologic oncology, and therefore, the surgical team is usually not the same for every procedure. Initially, the time of the procedure with the continent urinary diversion and VRAM flap was more than 9 –10 h, but with increasing experience, this has been adjusted to 6 –7 h. There was no correlation between the surgical time and the incidence of major complications. Hydroureter and hydronephrosis on CT or IVP are not an absolute contra-indication to pelvic exenteration unless the hydroureter is secondary to obvious pelvic and/or paraaortic lymphadenopathy or pelvic sidewall disease. We explore most of these patients as the site of the ureteral obstruction is often tumor around the uretero-vesical area, the parametria and the cardinal ligament/s. These patients are often excellent candidates for TPE if the pelvic and paraaortic lymph nodes are negative. We routinely check the integrity of the urinary diversion at 14 days post-operatively with a bilateral ureteral stentogram and a pouchogram to check the integrity of the ureteral anastomoses and the conduit in patients with continent conduits and ileal conduits. If there is no evidence of leakage of dye on these radiologic studies, the stents should be removed at that time. We have switched from using pediatric feeding tubes for stenting the ureters at the time of the urinary diversion procedure at TPE to single ‘‘J’’ ureteral catheters which are inserted over microglide wires (Boston Scientific/Microinvasive, Watertown, MA). These catheters are less likely to migrate or become dislodged from the ureters. They are soft, and the length can be adjusted according to the need of the individual patient. These stents are also less likely to kink or become blocked. We no longer use continuous suction drains in the pelvis and/ or abdomen. We still use a large Jackson-Pratt\ drain (Allegiance Corp., IL) but have it on alternating suction and to gravity as we believe that alternating suction and gravity drainage reduces the risk of small bowel and ureteral anastomotic leaks. Patients are now admitted the morning of the surgery. In the past, these patients were admitted up to 10 –14 days prior to the
procedure for Total Parenteral Nutrition, bowel preparation, consultation with a stoma nurse for ‘‘marking’’ for the colostomy and/or urostomy. This is accomplished in the outpatient setting, and we no longer utilize pre-operative TPN. In the past, our patients remained in the hospital until all the drains and the stents had been removed. We now send patients home with drains, stents and other appliances. Although this has not compromised the patient with regard to complications or survival, it makes it more difficult for the patient to cope with and adjust to this life changing procedure. The overall survival of our patients compares favorably with all previous reports [13,14,16– 19]. Patients with recurrent cervical cancer are clinically without evidence of disease at 5 years. These patients who are alive at 5 years have an 87% chance of being alive and free of disease at 10 or more years after the TPE. It was very interesting to note that 6 patients with cervical cancer developed late tumor recurrences at 6– 12 years after the TPE. Two of the 6 patients with late recurrences developed lung metastases, three patients presented with enlarged paraaortic nodes and one patient with liver metastases. All these patients had squamous cell carcinomas of the cervix, and all had received radiation and chemotherapy as their primary treatment modality. Two of the patients with positive paraaortic nodes presented with back pain secondary to hydroureter/hydronephrosis which was due to the enlarged paraaortic nodes. The third patient presented with recurrent pyelonephritis secondary to ureteral obstruction. All of these patients had annual CT scans and were without evidence of the hydronephrosis or hydroureter the year prior to their presentation with obvious tumor recurrence. Only 3 of these patients had the recurrence confirmed by cytology or pathology. Two of these patients had positive paraaortic nodes, and one patient had biopsy positive lung metastases. The other 3 patients declined further invasive procedures, intervention or treatment and the diagnosis of the late recurrence of the primary tumor was by exclusion. The incidence of deep vein thrombosis and pulmonary embolus was low in this group of extremely high-risk patients. All our patients received subcutaneous heparin as prophylaxis and early mobilization and ambulation post-operatively. When sequential compression devices were introduced into clinical practice in the early 1990s, we used these compression devices in addition to the subcutaneous heparin as prophylaxis in all our patients undergoing TPE. In our group of patients, there appeared to be a correlation between prolonged ileus and/or partial small bowel obstruction and anastomotic leaks, both ureteral and small or large bowel. When these patients have symptoms compatible with ileus and/ or partial small bowel obstruction for >5 days after the procedure, we recommend testing to confirm the integrity of all anastomotic sites. Early recognition allows improved chance for successful ‘‘conservative’’ management of these complications. We have decreased the length of broad-spectrum antibiotic administration for these patients as they are high-risk candidates for Candida and other fungal infections. These infections are common in this group of patients due to the indwelling
G.L. Goldberg et al. / Gynecologic Oncology 101 (2006) 261 – 268
ureteral stents, intra-peritoneal drains, central venous lines, naso-gastric tubes and prior radiation and chemotherapy. Candida colonization of the conduit and the ureteral stents is common, and the incidence of candidemia increases under these circumstances. We use prophylactic antibiotics and if treatment with broad-spectrum antibiotics is required, these should be discontinued as soon as clinically indicated. If prolonged antibiotic therapy is necessary in these patients, we usually initiate anti-fungal prophylaxis. The HIV status of 6 patients in this series was known. Many of these patients had their HIV status checked at the time of their initial diagnosis. We did not routinely check their HIV status at the time of disease recurrence and prior to the TPE. All these patients were controlled on anti-retroviral therapy prior to the surgery. These 6 patients appeared to have similar outcomes to the HIV negative group although the numbers are too small to comment on the clinical significance. In patients who are clinically free of disease >2 years, we have checked renal function annually. This includes serum renal chemistry, IVP or CT scans with intravenous contrast. All these patients demonstrated mild to moderate hydronephrosis and hydroureter on radiologic testing with contrast. Renal function remains normal, and there is usually no evidence of obstruction on these tests. When the results are equivocal with regard to renal function, a renal scan is used to confirm normal function. The >5-year follow-up of the renal function in our patients with both ileal conduits and continent urinary conduits remains within the normal range without evidence of decreased or diminished renal function in pts without clinical evidence of disease. When renal function or obstruction occurs, recurrent disease needs to be ruled out. We have long-term surviving patients with both the ileal conduit and the continent conduit who act as patient advocates. They help to discuss the surgical procedure in general and specifically the urinary diversion and vaginal reconstruction with patients who are being evaluated for a possible TPE. At present, TPE remains the only possible curative intervention for patients with recurrent carcinoma confined to the pelvis after initial surgery, radiation therapy and chemotherapy. The overall complication rate in our patients is similar to most reported series [14,16 –19]; the mortality rate in our series is the lowest reported to date. Our overall 5-year survival for these patients is encouraging, and advances and refinements in the surgical techniques have improved the reconstructive phase of the procedure and the potential for quality of life for these women. We believe that important factors are patient selection for TPE, patient education regarding the surgical procedure, the options with regard to urinary and colonic diversion, vaginal and pelvic floor reconstruction. The patient needs to understand her options at the time of the disease recurrence and the ability to meet with other patients who have experienced these procedures and their consequences. We will continue to modify our surgical approach to TPE in the hope that we will steadily reduce the morbidity of the procedure and increase the patients’ chances of long-term survival and a potentially good quality of life after this life altering and often life-saving intervention.
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References [1] Brunschwig A. Complete excision of pelvic viscera for abdominal carcinoma. Cancer 1948;1:177 – 88. [2] Barber HR. Relative prognostic significance of preoperative and operative findings in pelvic exenteration. Surg Clin North Am 1969;49:431 – 47. [3] Barber HRK. Chapter 63: Exenteration procedures in pelvic malignancy. In: J.J. Sciarra, T. McLin, C.H. Davis, editors. Davis’ Gynecology and Obstetrics. Haggerstown, MD: Harper and Row (Vol III). [4] Jimenez RE, Shoup M, Cohen AM, Paty PB, Guillem J, Wong WD. Contemporary outcomes of total pelvic exenteration in the treatment of colorectal cancer. Dis Colon Rectum 2003;46:1619 – 25. [5] Kakuda JT, Lamont JP, Chu DZ, Paz IB. The role of pelvic exenteration in the management of recurrent rectal cancer. Am J Surg 2003;186:660 – 4. [6] Chi DS, Barakat RR. Surgical management of advanced or recurrent endometrial cancer. Surg Clin North Am 2001;81:885 – 96. [7] Bosch FX, Munoz N, de Sanjose S, et al. Importance of human papillomavirus endemicity in the incidence of cervical cancer: an extension of the hypothesis on sexual behavior. Cancer Epidemiol Biomark Prev 1994;3:375 – 9. [8] Bosch FX, de Sanjose S, Chapter 1: Human papillomavirus and cervical cancer-burden and assessment of causality. (2003) 3 – 13. [9] Eluf-Neto J, Nascimento CM. Cervical cancer in Latin America. Semin Oncol 2001;28:188 – 97. [10] Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide [see comments]. J Pathol 1999;189:12 – 9. [11] Einstein MH, Goldberg GL. Human papillomavirus and cervical neoplasia. Cancer Investig 2002;1080 – 5. [12] Lawhead Jr RA, Clark DG, Smith DH, Pierce VK, Lewis Jr JL. Pelvic exenteration for recurrent or persistent gynecologic malignancies: a 10year review of the Memorial Sloan – Kettering Cancer Center experience (1972 – 1981). Gynecol Oncol 1989;33:279 – 82. [13] Averette HE, Lichtinger M, Sevin BU, Girtanner RE. Pelvic exenteration: a 15-year experience in a general metropolitan hospital. Am J Obstet Gynecol 1984;150:179 – 84. [14] Rodriguez Cuevas H, Torres A, de la Garza M, Hernandez D, Herrera L. Pelvic exenteration for carcinoma of the cervix: analysis of 252 cases. J Surg Oncol 1988;38:121 – 5. [15] Lopez MJ, Standiford SB, Skibba JL. Total pelvic exenteration. A 50-year experience at the Ellis Fischel Cancer Center. Arch Surg 1994;129:390 – 5 [discussion 395 – 6]. [16] Soper JT, Berchuck A, Creasman WT, Clarke-Pearson DL. Pelvic exenteration: factors associated with major surgical morbidity. Gynecol Oncol 1989;35:93 – 8. [17] Goldberg JM, Piver MS, Hempling RE, Aiduk C, Blumenson L, Recio FO. Improvements in pelvic exenteration: factors responsible for reducing morbidity and mortality. Ann Surg Oncol 1998;5:399 – 406. [18] Morley GW, Hopkins MP, Lindenauer SM, Roberts JA. Pelvic exenteration, University of Michigan: 100 patients at 5 years. Obstet Gynecol 1989;74:934 – 43. [19] Rutledge FN, McGuffee VB. Pelvic exenteration: prognostic significance of regional lymph node metastasis. Gynecol Oncol 1987;26: 374 – 80. [20] Beitler JJ, Anderson PS, Wadler S, et al. Pelvic exenteration for cervix cancer: would additional intraoperative interstitial brachytherapy improve survival? Int J Radiat Oncol Biol Phys 1997;38:143 – 8. [21] Smith HO, Genesen MC, Runowicz CD, Goldberg GL. The rectus abdominis myocutaneous flap: modifications, complications, and sexual function. Cancer 1998;83:510 – 20. [22] Bricker EM. Bladder substitution after pelvic evisceration. Surg Clin North Am 1950;30:1511 – 21. [23] Nurmi M, Puntala P, Alanen A. Evaluation of 144 cases of ileal conduits in adults. Eur Urol 1988;89 – 93. [24] Penalver MA, Bejany D, Donato DM, Sevin BU, Averette HE. Functional characteristics and follow-up of the continent ileal colonic urinary reservoir. Miami pouch. Cancer 1993;71:1667 – 72. [25] Penalver M, Donato D, Sevin BU, Bloch WE, Alvarez WJ, Averette H.
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Complications of the ileocolonic continent urinary reservoir (Miami pouch). Gynecol Oncol 1994;52:360 – 4. [26] Hatch KD, Shingleton HM, Soong SJ, Baker VV, Gelder MS. Anterior pelvic exenteration. Gynecol Oncol 1988;31:205 – 16. [27] Berek JS, Hacker NF, Lagasse LD. Rectosigmoid colectomy and reanastomosis to facilitate resection of primary and recurrent gynecologic cancer. Obstet Gynecol 1984;64:715 – 20. [28] Clarke-Pearson DL, DeLong ER, Synan IS, Coleman RE, Creasman WT.
Variables associated with postoperative deep venous thrombosis: a prospective study of 411 gynecology patients and creation of a prognostic model. Obstet Gynecol 1987;69:146 – 50. [29] Lockhart JL, Pow-Sang JM, Persky L, Kahn P, Helal M, Sanford E. A continent colonic urinary reservoir: the Florida pouch. J Urol 1990;144:864 – 7. [30] Stanhope CR, Symmonds RE. Palliative exenteration-what, when, and why? Am J Obstet Gynecol 1985;152:12 – 6.
Total pelvic exenteration: The Albert Einstein College of Medicine/Montefiore Medical Center Experience (1987 to 2003)i Gary L. Goldberg *, Paniti Sukumvanich, Mark H. Einstein, Harriet O. Smith, Patrick S. Anderson, Abbie L. Fields Division of Gynecologic Oncology, Department of Obstetrics and Gynecology and Women’s Health, Albert Einstein College of Medicine and Montefiore Medical Center, 1825 Eastchester Road-Room 722, Bronx, NY 10461, USA Received 26 May 2005 Available online 19 January 2006
Abstract Objective. To review the trends, modifications and results of 103 consecutive total pelvic exenterations (TPE) performed at the Montefiore Medical Center and Albert Einstein College of Medicine from 1987 to 2003. Methods. All patients who underwent TPE from January 1987 to December 2003 were included. The medical record, complications, followup, clinical status and demographic information were entered in a database. The procedure performed, the method of urinary diversion, colonic diversion, pelvic floor support and vaginal reconstruction were documented. Surviving patients were surveyed regarding their satisfaction with the urinary diversion, the vaginal reconstruction and their sexual function since the surgery. Results. 103 pts were identified. Indications for TPE were recurrent cancers of the cervix (95), endometrium (2), colon and rectum (5), vulva (1). Overall 5-year survival was 47%. 5-year survival for pts with recurrent cervix cancer was 48%. Six pts (6%) recurred >5 years after the TPE. 14 pts (14%) had ureteral anastomotic leaks (no difference between ileal conduit 9/65 (14%) versus 5/38 (13%) continent conduit ( P = 0.92). 34 pts (89%) with continent conduits were ‘‘continent.’’ 14 pts (17%) had wound complications. 4 pts (4%) had parastomal hernias. 5/11 (46%) pts who had a low rectal reanastomosis developed recurrence in the pelvis. 21/39 (54%) of pts with continent conduits would choose an ileal conduit if they had the option again. Long-term renal function was similar in pts with ileal and continent conduits. Mesh of any type for pelvic floor reconstruction is associated with infection and bowel/urinary fistulas. VRAM flaps for neovagina fill the pelvic dead space, reduce the risk of fistulas and 20/36 pts (55%) are sexually active. Conclusions. Our overall 5-year survival is encouraging, and modifications in surgical technique have improved the reconstructive phase. Low rectal anastomoses at TPE adversely affects survival. Many of our pts with continent urinary diversions would not choose this method again. Mesh of any type is associated with sepsis and bowel/urinary fistulas. VRAM for neovagina reduces fistula rate and are functional in >55% of pts. TPE remains a potentially curative option for these pts. D 2005 Elsevier Inc. All rights reserved. Keywords: Total pelvic exenteration; Complications; Urinary diversion; Recurrent cervical cancer; Cancer
Introduction Over 50 years ago, pelvic exenteration was first described by Brunschwig and colleagues from the Memorial Hospital in New York [1]. Initially, pelvic exenteration was utilized for the palliative surgical management of advanced and recurrent gynecologic cancers but, over the next 10 –15 years, evolved i
Presented in part at the annual Society of Gynecologic Oncologists Meeting in Miami in March 2005. * Corresponding author. Fax: +1 718 904 2774. E-mail address: [email protected] (G.L. Goldberg). 0090-8258/$ - see front matter D 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.ygyno.2005.10.011
into a curative intervention for advanced and recurrent gynecologic cancers confined to the central pelvis [2,3]. The extent of the surgical procedure required has been adapted to the site and location of the recurrent or residual disease. Total pelvic exenteration (TPE) entails the en bloc resection of the pelvic viscera in both the anterior and posterior urogenital compartments and is the only available procedure for extensive tumors of the cervix, uterus, vagina, vulva, colon (usually recto-sigmoid), bladder, urethra and occasionally ovary [4– 6]. Currently, the primary role of TPE is for the treatment of cancers of the cervix that recur in the central pelvis following
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radiation therapy with or without chemotherapy in patients with no evidence of occult metastatic disease outside the pelvis. Although the incidence of advanced stage cervical cancer appears to be declining in many developed countries, it remains a significant problem for women in developing and third world countries [7 –11]. It is a major health care issue in South America (and other developing and third world countries) where it is still the most common cancer in women [9]. There have been numerous reports describing the surgical procedure, technique and the outcome from numerous prestigious institutions around the world [5,6,12 –19]. The patient selection criteria, peri-operative preparation and post-operative care have changed significantly over the past two decades. The surgical procedure has evolved from a purely extirpative/ exenterative one to an operation that includes a reconstructive phase which has assumed even greater importance in recent years with refinements in urinary diversion, colon sparing surgery, preservation of the anal sphincter and vaginal and pelvic floor reconstruction. In keeping with other large academic medical centers, we have made significant modifications to our surgical techniques for both the extirpative and the reconstructive phases of the total pelvic exenteration procedure at the Albert Einstein College of Medicine and Montefiore Medical Center over the past 18 years. We have previously published a series of patients where we described the risk factors for poor prognosis at the time of TPE and those patients who might benefit from intraoperative or post-operative brachytherapy [20]. We have also reported on the modifications, complications and sexual function with regard to vaginal reconstruction using the Vertical Rectus Abdominis Myocutaneous (VRAM) flap at the time of TPE [21]. The majority of the alterations and modifications to the surgical procedures at TPE described in this report were initiated and performed by the primary author (GLG). Materials and methods After IRB approval (protocol #04-01-011E), there was a systematic review of in-patient and out-patient medical records from all patients who underwent TPE on the gynecologic oncology service at the Albert Einstein College of Medicine/Montefiore Medical Center from January 1987 to December 2003. Pts who underwent an anterior exenteration only or a posterior exenteration only were excluded from this analysis. A database was developed abstracting the predetermined variables of interest from the operative report, pathology reports, peri-operative studies, hospital course, duration of hospital stay, readmissions, operative and long-term complications, and disease status as of December 2003. Demographic information includes age, race, date of diagnosis, initial FIGO stage, date of TPE, histology, prior therapy including radiation therapy and/or chemotherapy. Other data extracted included the routine pre-operative and postoperative testing, CT scan/MRI, bone scan and renal scans. The types of surgical procedures performed, including the method of urinary diversion, colonic diversion, pelvic floor support and vaginal reconstruction was documented. Surviving patients were surveyed regarding their satisfaction with the vaginal reconstruction and their sexual function after the surgery. However, there was no baseline information for these patients regarding their sexual activity/function prior to the TPE. Thus, we were unable to compare their sexual activity pre- and post-TPE. This is a continuation of the initial patients reported by our group in 1998 [21].
Patients with continent urinary diversion were also questioned regarding their satisfaction with the procedure and related issues. The patients were questioned regarding their satisfaction with the results, specifically, urinary continence, absence of a bag/appliance, convenience and/or interference with their activities of daily living and whether they would choose a continent diversion again or an ileal conduit with a bag if they had to undergo the procedure again. Renal function was tested pre-operatively and post-operatively in all patients including blood chemistry, IVP or CT scan as clinically indicated. There was annual evaluation of the renal tract in the surviving patients with documentation of the results. Patients were followed in the office every 3 months for the first 2 years, then every 6 months until the fifth year and then annually thereafter. The surgical techniques used for the vaginal reconstruction [21], urinary diversion (ileal conduit or continent conduit [22 – 25] and low rectal anastomosis [26,27] have all been previously reported. Modifications unique to the Albert Einstein College of Medicine/Montefiore Medical Center experience will be presented. Statistical analysis, where appropriate, included Chi-square and Fischer’s Exact test.
Results Between 1987 and 2003, TPE was performed on 103 patients. We have follow-up information on all the patients in this group. Additional demographic characteristics are shown in Table 1. The mean age was 52.7 years (range 24 –81 years). The race and ethnic distribution was as follows: Caucasian (36%), Hispanic White (34%), African American (26%) and Asian – South Island/Pacific (4%). The majority of the patients (95) underwent the procedure for recurrent cervical cancer, 2 for recurrent endometrial cancer, 5 for persistent recto-sigmoid cancer after radiation and chemotherapy and 1 for recurrent vulva cancer (see Table 2). All the patients received pelvic radiation therapy prior to the TPE. Some patients had received extended radiation fields and brachytherapy, in addition to the pelvic radiation. Fifty-three patients (51%) received chemotherapy in addition to or concomitant with the radiation therapy and 50 patients (49%) received radiation therapy alone. Of the 95 patients with cervix cancer, the histo-pathology at the time of their diagnosis was that 75 (79%) had squamous cell carcinoma, 18 (19%) had adenocarcinoma and 2 (2%) had adenosquamous carcinoma. There was one peri-operative mortality in our series of patients. This patient expired on the 48th post-operative day
Table 1 Patient demographics #
(%)
(n = 103) Race AfricanAmerican Hispanic Caucasian Asian
27 35 37 4
26 34 36 4
Histology Squamous Adenocarcinoma Adenosquamous
76 25 2
74 24 2
Prior treatment Chemo/RT RT only
53 50
51 49
G.L. Goldberg et al. / Gynecologic Oncology 101 (2006) 261 – 268 Table 2 Primary cancer site Cervical cancer Endometrial cancer Colon cancer Vulva cancer
95 2 5 1
from possible sepsis related to a ureteral anastomotic leak. A pulmonary embolus could not be excluded as the patient’s family refused an autopsy to further clarify the cause of death. Another patient died >90 days post-operatively from sepsis, probably related to the mesh used for the pelvic floor. There were no intra-operative or immediate post-operative deaths in our series of patients. Thus, the immediate peri-operative survival rate in this group of patients was 98%. Complications As illustrated in Table 3, the majority of patients had febrile morbidity (71%). Urinary tract infections were documented in 37 patients. Of these 37 patients, 29 had continent urinary diversions and 8 had ileal conduits. Urinary tract infection/ pyelonephritis appears to be more common after TPE in those patients with continent conduits ( P < 0.001). Six patients with continent conduits (16%) had persistent difficulty with selfcatheterization despite adequate initial training and supervision in performing the procedure. Fourteen patients (14%) developed ureteral anastomotic leaks after the TPE. There was no significant difference in the incidence of ureteral anastomotic leaks between the ileal conduit group (9/65, 14%) and the continent conduit group (5/38, 13%, P = 0.92). 12/14 pts with ureteral leaks were in those who had a mesh placed to cover the denuded pelvic floor. The most common co-factor associated with an anastomotic leak was the use of mesh, irrespective of the type of mesh used. In order to perform the low rectal anastomosis and for the patient to have fecal continence, you require at least 4– 5 cm of rectum, and this means resection at the time of exenteration at/or very close to the original tumor or the site of the initial pelvic recurrence. We strongly believe that this affects the patients overall survival. Table 3 Complications Complication
#
(%)
Febrile morbidity UTI/Pyelonephritis Wound complications Difficulty with self catheterization Ureteral/Anastomotic leaks GI fistulas Pouch incontinence Small bowel obstruction Thromboembolic complications Ureteral stricture Stomal stricture Parastomal hernia Pouch fistula Urinary stones Mortality
73/103 37/103 17/103 6/38 14/103 11/103 4/38 9/103 7/103 5/103 4/103 4/103 1/38 2/103 1/103
71 36 17 16 14 11 11 9 7 5 4 4 3 2 1
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Eleven patients developed sepsis associated with the mesh that was used for the pelvic floor, and three of these subsequently developed entero-cutaneous or entero-perineal fistulas. Based on the current literature regarding the risk for symptomatic deep venous thrombosis [28], this complication was much lower than clinically anticipated. Four patients (3.9%) developed symptomatic deep venous thromboses postoperatively requiring anticoagulation. All four patients received anticoagulant therapy and in our series, there were no documented pulmonary emboli. The absolute number of pts who developed DVT in this series is unknown as they were not tested for unless clinically indicated. Seven patients had rectoperineal fistulas (excluding the 4 fistulas following low rectal anastomosis), and one patient had a urinary pouch-cutaneous fistula from a continent conduit. There were no entero- or colocutaneous or perineal fistulas in our patients who had a VRAM flap. The VRAM appears to fill the dead space in the pelvic cavity, and the radiated small bowel does not become adherent to the mesh or the denuded pelvic floor which increases the likelihood of a fistula. There were 4 patients (4%) who developed parastomal hernias at their colostomy sites. These patients were all managed conservatively. Wound complications occurred in 14 patients (17%). None of the patients had a wound dehiscence. Three patients required mesh to close the abdominal wall – all following a VRAM flap – 2 of these developed seromas with separation of the wound. The rest of the wound complications were varying degrees of wound infection and/or separation. None of these patients required surgical intervention for the wound complications. Urinary diversion Sixty-five patients (63%) had an ileal conduit and 39 patients (37%) had a continent urinary diversion. Initially, we used a modification of the ‘‘Indiana’’ pouch [29] and subsequently our own modifications of the ‘‘Miami’’ pouch [24,25] (Table 4). Fourteen patients had ureteral anastomotic leaks (14%). Four of these 14 patients required surgical correction despite initial conservative management. The other 10 patients (71%) were managed conservatively. Five patients developed ureteral strictures. Three of the 5 patients with ureteral strictures occurred in patients with a continent conduit and in 2 patients with an ileal conduit. This was not statistically significant ( P = 0.4). All the strictures were managed conservatively. No ureteral strictures occurred Table 4 Urinary diversion/low rectal anastomosis Type
#
(%)
Urinary diversion Ileal conduit Continent conduit
65 38
63 37
Low rectal reanastomosis Total Recurrent disease in pelvis Fistulas
11 5 4
45 36
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in our patients with continent conduits after we changed our method of ureteral implantation into the conduit. Initially, we used a technique of tunneling the implanted ureter through the tenia of the cecum and/or ascending colon (the reservoir). Subsequently, we have changed to direct ureteral implantation without any tunneling of the ureter. Two patients with continent conduits developed urinary stones in the conduit. Both patients had their calculi managed as outpatients. Thirtyfour patients (89%) with the continent conduit were actually continent of urine. Four patients were incontinent of urine, and all 4 have refused revision of the pouch or any other invasive intervention. These 4 patients were managed with indwelling foley-type sialastic catheters and a urostomy bag to control the urinary incontinence. There was one patient who developed a continent conduit-cutaneous fistula. This patient required surgical correction of the fistula and revision of the pouch. The renal function in patients who were clinically free of disease remained normal post-operatively with both the ileal conduit and the continent conduit. All these surviving patients displayed mild to moderate hydronephrosis on IVP and/or CT scan without evidence of obstruction or altered renal function by chemistry and/or renal perfusion scan when clinically indicated. The most common admission diagnosis was for urinary tract infections/pyelonephritis. This appeared to be more common in patients with continent conduits especially where there was difficulty with self-catheterization. Four patients (10%) with a continent conduit developed stomal stricture or stenosis. This required active intervention with stomal dilation on a regular basis. None of these patients has required surgical intervention, and one patient has had the conduit for >8 years. Twenty-one patients (54%) reported difficulty and/or annoyance with self-catheterization, problems and/or difficulty in with dealing with self-catheterization at night. All of these 21 patients expressed the opinion that they would undoubtedly have chosen an ileal conduit with a bag if they had the option again and needed to have the procedure repeated. Low rectal anastomosis Consistent with early reports in the literature [26,27], we started offering our patients with recurrent disease that appeared to be localized anterior recurrences, the option of low rectal anastomosis with conservation of the rectum and anus at the time of TPE (Table 4). Five of 11 patients (45%) with negative surgical margins and lymph nodes at the time of the TPE had early recurrent disease in the pelvis at or near the site of the rectal anastomosis. There were 4 (36%) recto-perineal fistulas in this group. Three of the 4 patients developed fistulas secondary to disease recurrence at the site of the anastomosis. We did not perform diverting colostomies in our patients undergoing low rectal anastomosis. We have abandoned the surgical option of low rectal anastomosis after our first 11 patients due to the high recurrence rate in the pelvis after these rectal sparing procedures and in our opinion, we believe it compromises the patient’s chance of long-term survival.
Vaginal reconstruction Forty-eight patients (47%) had vaginal reconstruction at the time of the TPE. Three patients (6%) had omentum/colon neovaginas, 9 (19%) had split thickness skin grafts (McIndoe type) and 36 (75%) had Vertical Rectus Abdominis Myocutaneous (VRAM) flaps. Our initial series VRAM flaps at the time of TPE was reported by Smith et al. in 1998 [21]. Additional 20 cases have been performed since that report and the overall results and outcome are similar. The anatomic restoration is excellent, and the graft fills the entire dead space in the pelvic cavity. There were no graft rejections in our series at Einstein/ Montefiore. There were 4 patients with partial necrosis of the VRAM neovagina. Three of these 4 patients were managed conservatively with eventual healing and one patient required surgical revision with an excellent result. The patients with the VRAM report sexual function in >50% of cases (see Table 5). Pelvic floor reconstruction We have utilized many different techniques and materials in order to cover and fill the denuded pelvis and dead space at the time of TPE. Initially, we used an omental sling or pedicle graft, and later, we tried different types of mesh to act as a sling and to cover the denuded pelvic cavity. It did not matter whether we used absorbable mesh (Vicryl), non-absorbable mesh (Prolene), allografts and other materials such as bovine pericardium, we experienced a high rate of enteric/ureteral anastomotic fistulas and sepsis related to these materials. Entero-cutaneous, entero-perineal fistulas and small bowel and ureteral anastomotic leaks were associated with the mesh or other foreign material. This occurred despite the use of omentum sutured over to cover the top of the mesh. With regard to the use of foreign graft material for pelvic floor reconstruction: the highest rate of small bowel fistulas and/or ureteral anastomotic leaks occurred in patients where Table 5 Neovagina
Neovagina Total Omentum/Colon McIndoe/Split-Thickness skin graft VRAM flap
#
(%)
48/103 3/48 9/48 36/48
47 6 19 75
# of pts
NED
DOD
18 3
2 13
VRAM Flap/Neovagina and sexual function Total 36 Sexually active 20 (56) Not sexually active 16 (45) # Satisfaction with VRAM flap/neovagina (N = 20) Very satisfied 5 Satisfied 12 Somewhat satisfied 3 Not satisfied 0
(%) 25 60 15
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these materials were used. We had a total of 14 ureteral anastomotic leaks and 11 GI fistulas. Of the 14 ureteral anstomotic leaks, 12 were in patients with a foreign graft and of the 11 GI fistulae, 6 had foreign material grafts. All of these 6 patients with GI fistulas had ureteral anstomotic leaks as well. Of the total leaks and fistulas, 18 of the 25 were associated with foreign material grafts. We have had no GI fistulas or ureteral anastomotic leaks to date where the pelvic cavity is ‘‘filled’’ with the rectus myocutaneous graft. Survival The 5-year survival for all our patients following TPE is 47% (Table 6). The overall survival rate for patients who are alive at 5 years is 87%. Six patients have developed recurrent disease more than 5 years after the TPE. Two of these 6 patients developed lung metastases diagnosed at 7 and 8 years after the TPE, respectively. Three of the 6 patients were diagnosed with enlarged paraaortic nodes at 6, 8, and 12 years respectively after the TPE. One of the 6 patients was diagnosed with liver metastases 7 years after the surgery. Overall 42 patients (41%) are clinically without evidence of disease, and 2 patients (2%) are alive with disease. Fifty-four patients (52%) are dead of the disease, and 5 patients (5%) have died from other causes including, myocardial infarction (3), stroke (1), motor vehicle accident (1). Of the 5 patients who have died of other causes, 2 were clinically without evidence of disease at 5 years. The 5-year survival rate for the 95 patients who had the TPE for recurrent cervix cancer is 48% (46/95). There were 25 patients with adenocarcinoma in this group, 5 of the 25 had adenocarcinoma of the rectosigmoid, 2 of the 25 had adenocarcinoma of the endometrium and 18 had adenocarcinoma of the cervix. There was no difference in the 5-year survival for patients with adenocarcinoma of the cervix 6/18 (33%) versus 41/77 (53%) patients with squamous cell carcinoma of the cervix ( P = 0.13). The most common admission diagnosis was for urinary tract infections/pyelonephritis. This appeared to be more common in patients with continent conduits especially where there was difficulty with self-catheterization.
Table 6 Disease status/survival
NED AWD DOD DOC 5-year survival—all patients >5-year survival—all patients 5-year survival—cervix cancer patients only >5-year survival—cervix cancer patients only Dead >5 years Lung metastases Paraaortic nodes Liver metastases
#
(%)
42 2 54 5 48 42 46/95 40/95 6 2 3 1
41 2 53 5 47 41 48 42 (at 7, 8 years) (at 6, 8, 12 years) (at 7 years)
NED—no evidence of disease; DOD—dead of disease; AWD—alive with disease; DOC—dead of other causes.
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Comment We have made a number of significant modifications to the TPE procedure over the past 18 years at the Albert Einstein College of Medicine/Montefiore Medical Center. We do not rely on examination under anesthesia, CT scan or MRI reports to determine whether our patients are eligible candidates for TPE. We offer the patient the option of an exploratory laparotomy to determine whether they are eligible or ineligible for the procedure. We generally do not perform palliative TPE and will usually abort the procedure if the lymph nodes are positive or if the tumor is not resectable from the pelvic sidewall with grossly clear surgical margins. In view of some reports in the literature we have completed the TPE in 3 patients with positive pelvic node/s. Two of the 3 patients are dead of disease in less than 1 year, and one patient is alive and clinically without evidence of disease at 11 months. This patient received intra-operative placement of brachytherapy after complete resection of the nodes [19,30]. Our group previously reported the risk factors for recurrence at the time of TPE and those patients who we believe might benefit from intra- or post-operative brachytherapy [20]. We have modified our technique of continent urinary diversion procedures in the following ways. We no longer use separate independent drainage of the conduit with a Mallinckrodt\ (Chicago, IL) or other drain. This was associated with a pouch-cutaneous fistula that required surgical revision and does not appear to reduce the complications. We have altered our method of ureteral implantation into the pouch from tunneling the ureter through the tenia of the colon to direct implantation of the ureter in the conduit without tunneling. Difficulty with self-catheterization was more common in our initial series of patients undergoing continent urinary diversion as we made the ileal portion of the conduits too long. The ileal segment then tended to become tortuous. Together with the tapering of the ileal segment and the ileo-cecal valve, this resulted in patients experiencing difficulty with self-catheterization. We subsequently have made the ileal segment shorter, and we now attach the pouch with sutures to the anterior abdominal wall. Both of these modifications have resulted in fewer patients experiencing difficulty with self-catheterization without affecting the continence of the urinary diversion. We have shortened the length of the ileal portion used for the stoma and taper this according to the body habitus of the patient and the state of the blood supply of the small bowel being utilized. We anchor the conduit to the anterior abdominal wall to try to prevent ureteral anastomotic leaks and other fistulae by reducing the risk of the conduit becoming adherent to the denuded pelvic floor. We discussed the option and performed low rectal anastomoses in eligible patients who elected to have a continent urinary diversion. This allowed these patients the opportunity to have no external stomal hardware, appliances or bags. The anastomotic breakdown and fistula rate for our patients undergoing low rectal anastomosis were similar to that reported by others [24,26]. Due to the high rate of early tumor recurrence
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at or near the site of the primary low rectal anastomosis in our initial series of 11 patients, we no longer offer our patients the choice of a low rectal anastomosis at the time of TPE. We believe it compromises their chances of survival. We have stopped using synthetic or other materials to fill the dead space and cover the denuded pelvic floor at the time of TPE. In our experience, the VRAM flap is the most effective method to fill the dead space. It also appears to be the most effective method of vaginal reconstruction at the time of the TPE. The VRAM flap fills the dead space very effectively and is less likely to be associated with any form of GI fistula. It is highly effective for the creation of a neovagina, and our results to date are excellent with regard to restoration of a potentially functional neovagina. Graft rejection has not been a problem in our series of 36 patients to date. The blood supply to the flap is easily identifiable and can be protected throughout the procedure so that the risk of graft necrosis and graft rejection is diminished or avoided. There was a ‘‘learning curve’’ when we initiated continent urinary diversion and VRAM flaps as part of the reconstructive phase of the TPE procedure. Our institution is an academic teaching hospital, and we have the responsibility for training fellows in gynecologic oncology, and therefore, the surgical team is usually not the same for every procedure. Initially, the time of the procedure with the continent urinary diversion and VRAM flap was more than 9 –10 h, but with increasing experience, this has been adjusted to 6 –7 h. There was no correlation between the surgical time and the incidence of major complications. Hydroureter and hydronephrosis on CT or IVP are not an absolute contra-indication to pelvic exenteration unless the hydroureter is secondary to obvious pelvic and/or paraaortic lymphadenopathy or pelvic sidewall disease. We explore most of these patients as the site of the ureteral obstruction is often tumor around the uretero-vesical area, the parametria and the cardinal ligament/s. These patients are often excellent candidates for TPE if the pelvic and paraaortic lymph nodes are negative. We routinely check the integrity of the urinary diversion at 14 days post-operatively with a bilateral ureteral stentogram and a pouchogram to check the integrity of the ureteral anastomoses and the conduit in patients with continent conduits and ileal conduits. If there is no evidence of leakage of dye on these radiologic studies, the stents should be removed at that time. We have switched from using pediatric feeding tubes for stenting the ureters at the time of the urinary diversion procedure at TPE to single ‘‘J’’ ureteral catheters which are inserted over microglide wires (Boston Scientific/Microinvasive, Watertown, MA). These catheters are less likely to migrate or become dislodged from the ureters. They are soft, and the length can be adjusted according to the need of the individual patient. These stents are also less likely to kink or become blocked. We no longer use continuous suction drains in the pelvis and/ or abdomen. We still use a large Jackson-Pratt\ drain (Allegiance Corp., IL) but have it on alternating suction and to gravity as we believe that alternating suction and gravity drainage reduces the risk of small bowel and ureteral anastomotic leaks. Patients are now admitted the morning of the surgery. In the past, these patients were admitted up to 10 –14 days prior to the
procedure for Total Parenteral Nutrition, bowel preparation, consultation with a stoma nurse for ‘‘marking’’ for the colostomy and/or urostomy. This is accomplished in the outpatient setting, and we no longer utilize pre-operative TPN. In the past, our patients remained in the hospital until all the drains and the stents had been removed. We now send patients home with drains, stents and other appliances. Although this has not compromised the patient with regard to complications or survival, it makes it more difficult for the patient to cope with and adjust to this life changing procedure. The overall survival of our patients compares favorably with all previous reports [13,14,16– 19]. Patients with recurrent cervical cancer are clinically without evidence of disease at 5 years. These patients who are alive at 5 years have an 87% chance of being alive and free of disease at 10 or more years after the TPE. It was very interesting to note that 6 patients with cervical cancer developed late tumor recurrences at 6– 12 years after the TPE. Two of the 6 patients with late recurrences developed lung metastases, three patients presented with enlarged paraaortic nodes and one patient with liver metastases. All these patients had squamous cell carcinomas of the cervix, and all had received radiation and chemotherapy as their primary treatment modality. Two of the patients with positive paraaortic nodes presented with back pain secondary to hydroureter/hydronephrosis which was due to the enlarged paraaortic nodes. The third patient presented with recurrent pyelonephritis secondary to ureteral obstruction. All of these patients had annual CT scans and were without evidence of the hydronephrosis or hydroureter the year prior to their presentation with obvious tumor recurrence. Only 3 of these patients had the recurrence confirmed by cytology or pathology. Two of these patients had positive paraaortic nodes, and one patient had biopsy positive lung metastases. The other 3 patients declined further invasive procedures, intervention or treatment and the diagnosis of the late recurrence of the primary tumor was by exclusion. The incidence of deep vein thrombosis and pulmonary embolus was low in this group of extremely high-risk patients. All our patients received subcutaneous heparin as prophylaxis and early mobilization and ambulation post-operatively. When sequential compression devices were introduced into clinical practice in the early 1990s, we used these compression devices in addition to the subcutaneous heparin as prophylaxis in all our patients undergoing TPE. In our group of patients, there appeared to be a correlation between prolonged ileus and/or partial small bowel obstruction and anastomotic leaks, both ureteral and small or large bowel. When these patients have symptoms compatible with ileus and/ or partial small bowel obstruction for >5 days after the procedure, we recommend testing to confirm the integrity of all anastomotic sites. Early recognition allows improved chance for successful ‘‘conservative’’ management of these complications. We have decreased the length of broad-spectrum antibiotic administration for these patients as they are high-risk candidates for Candida and other fungal infections. These infections are common in this group of patients due to the indwelling
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ureteral stents, intra-peritoneal drains, central venous lines, naso-gastric tubes and prior radiation and chemotherapy. Candida colonization of the conduit and the ureteral stents is common, and the incidence of candidemia increases under these circumstances. We use prophylactic antibiotics and if treatment with broad-spectrum antibiotics is required, these should be discontinued as soon as clinically indicated. If prolonged antibiotic therapy is necessary in these patients, we usually initiate anti-fungal prophylaxis. The HIV status of 6 patients in this series was known. Many of these patients had their HIV status checked at the time of their initial diagnosis. We did not routinely check their HIV status at the time of disease recurrence and prior to the TPE. All these patients were controlled on anti-retroviral therapy prior to the surgery. These 6 patients appeared to have similar outcomes to the HIV negative group although the numbers are too small to comment on the clinical significance. In patients who are clinically free of disease >2 years, we have checked renal function annually. This includes serum renal chemistry, IVP or CT scans with intravenous contrast. All these patients demonstrated mild to moderate hydronephrosis and hydroureter on radiologic testing with contrast. Renal function remains normal, and there is usually no evidence of obstruction on these tests. When the results are equivocal with regard to renal function, a renal scan is used to confirm normal function. The >5-year follow-up of the renal function in our patients with both ileal conduits and continent urinary conduits remains within the normal range without evidence of decreased or diminished renal function in pts without clinical evidence of disease. When renal function or obstruction occurs, recurrent disease needs to be ruled out. We have long-term surviving patients with both the ileal conduit and the continent conduit who act as patient advocates. They help to discuss the surgical procedure in general and specifically the urinary diversion and vaginal reconstruction with patients who are being evaluated for a possible TPE. At present, TPE remains the only possible curative intervention for patients with recurrent carcinoma confined to the pelvis after initial surgery, radiation therapy and chemotherapy. The overall complication rate in our patients is similar to most reported series [14,16 –19]; the mortality rate in our series is the lowest reported to date. Our overall 5-year survival for these patients is encouraging, and advances and refinements in the surgical techniques have improved the reconstructive phase of the procedure and the potential for quality of life for these women. We believe that important factors are patient selection for TPE, patient education regarding the surgical procedure, the options with regard to urinary and colonic diversion, vaginal and pelvic floor reconstruction. The patient needs to understand her options at the time of the disease recurrence and the ability to meet with other patients who have experienced these procedures and their consequences. We will continue to modify our surgical approach to TPE in the hope that we will steadily reduce the morbidity of the procedure and increase the patients’ chances of long-term survival and a potentially good quality of life after this life altering and often life-saving intervention.
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