Pelvic Radical Surgery

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CANCERS UNIQUE TO WOMEN

PELVIC RADICAL SURGERY Hector M. Tarraza, MD, FACOG, FACS, and R. Mark Ellerkmann, MD

In 1809, a country surgeon named Ephraim McDowell, who was practicing in the rolling hills of Danville, Kentucky, performed the first successful elective laparotomy with subsequent ovariotomy. Over the ensuing 7 years, Dr. McDowell went on to perform two similar operations for gynecologic pathology, publishing his success in the seventh volume of the Eclectic Repertory and Analytical Review. This report made its way to England, where John Lizars, Professor of Surgery at the College of Surgeons of Edinburgh, made reference to it in his own 1925 publication, Observations on Extraction of Diseased Ovaria, in which he reported four similar ovariectomies that he had performed. Thus, the groundwork for radical abdominal gynecologic surgery was begun, and Dr. Ephraim McDowell has become known in surgical history as one of its founding fathers.37 RADICAL HYSTERECTOMY

Although around the world cervical carcinoma is the most common lethal gynecologic malignancy, its incidence in this country has decreased dramatically. This decrease is attributed to the advent of the Papanicolaou smear in the 1950s and its routine use as a screening tool and standard of care. In the United States, 14,000 women are diagnosed annually with cervical cancer, making it the second most common gynecologic malignancy and third most common malignancy in women. The age-adjusted incidence (20 cases per 100,000) increases in the third decade of life. The current treatment of cervical cancer is based on its history, known biologic behavior, and its stage or anatomic distribution. In general, for early disease up through stage Ila, radical surgery with complete excision of the From the Division of Gynecologic Oncology, Maine Medical Center, Portland, Maine SURGICAL ONCOLOGY CLINICS OF NORTH AMERICA VOLUME 7 •NUMBER 2 • APRIL 1998

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lesion is usually the preferred treatment of choice. Surgery can preserve ovarian function, result in less tissue injury, and is undertaken in a relatively short period of time. For advanced disease greater than Ila, radiation therapy has become the treatment of choice, because it has been shown to be superior in terms of morbidity and cure. The correct staging of cervical cancer has come to dictate therapy and provide prognosis. The International Federation of Gynecology and Obstetrics (FIGO) system has been accepted widely as the standard for staging of cervical cancer. In 1995, FIGO modified the staging criteria for stage I disease based on millimeters of invasion. Nevertheless, staging of cervical cancer is clinically rather than surgically based. Accepted diagnostic tools traditionally have been limited to the use of chest radiograph, cystoscopy, sigmoidoscopy, and intravenous pyelogram for official staging purposes. Within the last decade, CT, MR imaging, and transvaginal and transrectal ultrasonography have been used to detail the extent of disease, especially in terms of lymphatic involvement. The stage of any malignancy is a predictor of outcome. Based on data from the 1991 FIGO report, survival rates for patients with cervical cancer based on clinical stage range from 81.6% 5-year survival rate for stage I disease to 12.1%5-year survival rate for stage IV disease. 14 Histopathology is also an important factor in prognosis. A multivariate analysis of the histopathologic prognostic factors of cervical cancer in patients who undergo radical hysterectomy suggests a poorer prognosis with adenocarcinoma.22 In early stage disease, nodal involvement, predicted by depth of cervical stromal invasion, lymphatic and vascular space involvement, and tumor size is a significant prognostic indicator of survival. In a series of studies by Inn et al,19•20 the number of metastatic nodes was of more prognostic significance than either nodal size or bilaterality. After radical hysterectomy for stage lb and Ila disease and irrespective of adjuvant radiation therapy, negative nodal involvement is associated with a 90% survival rate versus a 65% survival rate if the nodes are positive. Other possible prognostic factors may include human papillomavirus status and DNA ploidy.51 MICROINVASION

In approaching the treatment of cervical cancer, several areas must be considered carefully. The first is the issue of "microinvasive" disease, which is defined differently depending on whether the FIGO classification-which considers the depth and width of the lesion-or the Society of Gynecologic Oncologists (SGO) classification-which considers the depth, lymphovascular space involvement (LVI), and multifocality of the lesion-is used. In general, the three most important criteria are considered to be the depth of invasion, LVI, and the status of cone margins, all of which are predictive of nodal involvement. Assuming all other prognostic factors are negative and the depth of invasion is less than 1 mm, the risk of lymph node involvement is clinically insignificant. Indeed, between 1 and 3 mm invasion, the risk is still minimal. This risk, however

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becomes substantially greater once the invasion exceeds 3 mm. Recent data demonstrate that for 3.1- to 5-mm invasive lesions, the risk of nodal involvement approximates 7%, yet such invasion may meet the official FIGO definition of "microinvasion." If LVI is concurrently present, this risk suddenly doubles. 10 Based on this context, treatment recommendations for microinvasive disease less than 3 mm of invasion with no LVI and negative cone margins include close follow-up (in a case in which fertility is desired) and simple modified radical hysterectomy. If LVI is seen or the depth of invasion exceeds 3 mm, however, a radical hysterectomy with pelvic lymphadenectomy is the treatment of choice. 21 Another important and controversial management problem concerns the treatment of "bulky" (i.e., large tumor) stage lb cervical lesions. Given the widely accepted premise that tumor volume correlates with both prognosis and resistance to radiation therapy, some authors have advocated neoadjuvant radiation therapy before surgery. Approximately 5% to 10% of stage lb and Ila lesions are defined as bulky, typically when a transverse diameter is more than 6 cm. Some data suggest improved outcome if these lesions are first radiated before surgery. Gallion et al1 6 reported a significant decrease in the incidence of pelvic recurrence in patients with stage lb more than 5 cm who were treated initially with radiation therapy followed by a simple extrafascial hysterectomy. The surgical complication rates, however, even for a simple hysterectomy after full or reduced dose pelvic radiation, were elevated by 10%.16 Morrow and Curtin33 recommend the use of adjuvant simple hysterectomy in all operable patients with stage lb and Ila lesions more than 4-cm diameter with squamous or glandular histology. At the time of surgery, they recommend sampling the common iliac and lower pelvic nodes and, if positive for residual disease, proceeding with a modified radical hysterectomy. OVARIAN MANAGEMENT

Whether to leave the ovaries in situ in early stage cervical cancer continues to depend on many factors. It has become standard practice to preserve ovaries in young premenopausal women who undergo radical hysterectomy for early cervical cancer. Surgically, transposing the ovaries out of the potential pelvic field of radiation, moving them to the paracolic gutters above the iliac crest, minimizing their exposure to radiation and thus preserving their function has been reported as helpful. 10 The concern for occult ovarian metastases has been raised by reports suggesting a 1% to 7% risk for stage lb adenocarcinoma of the cervix. The risk from squamous cell metastases with stage I and Ila is much lower. Still, given the risk of ovarian involvement, it is probably best not to transpose the ovaries. If postoperative radiation therapy is indicated, the ovaries should be included in the field. The argument not to transpose is further strengthened by painful ovarian cysts occurring near the kidney and premature ovarian failure, both of which have been reported. 34 (Editor's note: The sentiment expressed by Dr. James Orr in his article in this issue entitled "Cervical Cancer" reflects a contrary philosophy. The differences between

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authors is reflective of the overall controversies about managing normal ovaries during surgery for cervical cancer.) STAGE 18 AND llA

The management of lb and Ila cervical cancer has been debated for decades. As mentioned, for early cervical cancer up to stage Ila, radiation therapy and radical surgery offer comparable survival rates. In a large clinical trial of 2000 patients treated with radiation therapy at M.D. Anderson Hospital, Fletcher and Rutledge15 reported a 5-year cure rate ranging from 91.5% for stage I disease to 83.5% for stage Ila. These survival rates approximate those reported in several trials that examine surgical treatment for the same stage disease. 52 There are decided advantages to surgery, however, such as less long-term morbidity, less cost, surgical staging offering greater insight as to the disease distribution, conservation of ovaries, and less time of treatment. These advantages, coupled with current superior medical support and anesthesia, antibiotics, and blood banking, make radical hysterectomy a safe and effective operation for women of all ages. No longer should it be viewed as a "select" option for younger women. Historically, the development of the radical hysterectomy was publicized by Wertheim in 1912 after his experience with 500 cases. His mortality rate of 20%, combined with the discovery and introduction of radium therapy, impeded the evolution of radical hysterectomy. It was not until 1944 that Dr. J.V. Meigs at Harvard reinstituted the concept of radical hysterectomy. With "modern" surgical and medical techniques of his time, Meigs reported on the curative results of 47 patients treated with radical hysterectomy and bilateral pelvic lymphadenectomy without the high mortality rates of previous series. The procedure soon became popular not only for the treatment of early stage cervical carcinoma but also for stage II endometrial carcinoma, stage I vaginal carcinoma confined to the apex, and centrally persistent or recurrent carcinoma after radiation therapy. The operation as described by Meigs incorporated the Halstedian principle of radical en bloc dissection: the removal of all tissue adjacent to the cervix, including the upper third of the vagina, the entire uterosacral and uterovesicle ligaments, and the entire parametrium (Fig. 1). Meigs included pelvic lymphadenectomy to include dissection of the ureteral, obturator, hypogastric, and iliac nodes. Over the ensuing years, the radical hysterectomy underwent modification in terms of extent of resection and dissection. In an attempt to address and better define these variations on hysterectomy, Piver et al36 proposed five variations ranging from the class I or simple extrafascial hysterectomy indicated in cases of in situ or microinvasive disease less than 3 mm invasion to the class V ultraradical hysterectomy (i.e., exenteration) used in a central recurrent cervical carcinoma. Each class of hysterectomy can be performed with or without adenectomy or lymphadenectomy. The classification system logically tailors the operation to the

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Figure 1. Radical hysterectomy specimen. Note the entire paracervical, parametrial, and upper third of the vag ina.

extent of disease. For example, the type II, or modified radical hysterectomy, is favored by some surgeons for microinvasive disease up to 3 mm of invasion that demonstrates LVI, as salvage therapy after radiation in which a small cervical lesion remains, and possibly for endometrial cancer involving the lower uterine segment. The modified radical hysterectomy operation is similar to the "simple" or type I hysterectomy in some respects, but it differs by removing some portion of parametrial tissues. The retroperitoneal, pararectal, and paravesical spaces are developed to allow full visualization of the ureter. The ureter then can be unroofed rather than completely dissected and rolled laterally, and the medial half of the cardinal ligament is transected. The uterosacral ligaments, exposed by developing the rectovaginal space, are partially preserved by transecting them midway between the uterus and their sacral attachments, and the paracolpos (bladder pillars) are taken only to a level that allows resection of the proximal 1 to 2 cm of vagina. Using this approach, the blood supply to the distal ureter and bladder and the integrity of the autonomic nerves innervating the lower urinary tract can be preserved. THE MORE RADICAL HYSTERECTOMIES

Reserved for larger lesions for which an increased margin of resection is needed, the class III or Meigs-Okabayashi approach is known for its complete resection of the rectal and bladder pillars at their respective attachments, the resection of the cardinal ligaments at the pelvic sidewall, and resection of the upper half of the vagina. The class IV radical hyster-

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ectomy, indicated when hope exists of preserving the bladder in a recurrent centrally located lesion, attempts an even more extensive excision of the paravaginal tissue. Along with complete dissection of the ureter and removal of all periureteral tissue, the operation is also known for sacrificing the superior vesicle artery and, on occasion, the internal iliac vessels. Up to three fourths of the vagina is removed in this operation. The most radical operation in the Rutledge classification is the class V hysterectomy, a rarely performed operation indicated when either the extension of disease includes the bladder or distal urethra or when exenteration for a small central recurrence is not possible. Excision of the lesion is attempted and reimplantation of the ureter performed. Although not included in the Rutledge classification system, the Wertheim radical hysterectomy is the most widely performed radical hysterectomy in the United States today. Its indications include cases of stage lb and Ila carcinoma of the cervix, centrally located recurrent cervical cancer in postradiated patients, cases of endometrial cancer involving the cervix, and cases of stage I and II vaginal carcinoma involving the vaginal fornices. By resecting less vagina and preserving the posterior portion of the cardinal ligaments, thereby keeping the autonomic innervation of the bladder and rectum intact, it is considered less radical or potentially less morbid than the type III or Meigs-Okabayashi radical hysterectomy. THE TECHNIQUES

The initial steps and philosophies in radical hysterectomy follow those of any laparotomy for female pelvic malignancy. Obtaining washings and careful visual and tactile exploration of the pelvis and abdomen to evaluate extent of disease are performed. When confronting cervical cancer, particular care is taken to appreciate fully possible lymphatic, parametrial, and paracervical involvement. Because the parametria and paracolpos are the first tissues to be involved by contiguous invasion (2% of patients with stage lb cervical carcinoma have involvement of the lateral parametrium and two thirds of these patients have positive nodes43 ) biopsies of the enlarged nodes should be obtained and the anterior and posterior cul-de-sacs, lower uterine segment, and lateral fornices should be evaluated for palpable disease. If any findings of advanced disease are uncovered intraoperatively, modification of the surgical procedure (i.e., type of operation to be performed) should be contemplated and, when appropriate, changes made to fit the newly attained insight about disease distribution. If, after initial operative evaluation, the patient is still deemed to be a candidate for radical hysterectomy, the retroperitoneal spaces are opened and developed in the standard fashion. Examination of the retroperitoneal pelvic anatomy, including the ureters, major vessels, and lymphatics, for metastatic disease is carried out and suspicious tissues can be sent for frozen section. Here again, last minute changes in the operation may need to be made based on evolving information. Development of the paravesical, paravaginal, and pararectal spaces allows isolation of the re-

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spective intervening pedicles. The bladder pillar is isolated by dissection of the vesicouterine reflection, and the paravesical and paravaginal spaces are developed by dissecting between the obliterated umbilical artery and external iliac. Dissecting the ureter medially from the hypogastric artery, the pararectal space is developed and the cardinal ligament along with the uterine artery is isolated. The artery then can be ligated at its origin and attention turned to further dissection of the ureter and its unroofing, taking care not to strip it of its adventitia. Further dissection of the vesicouterine reflection and ligation of vesicocervical ligament allows the bladder flap to be pushed well below the level of the cervix. Attention can be turned posteriorly with dissection of the rectal-vaginal septum and isolation and transection of the uterosacral ligaments and proximal rectal pillars. The vesicouterine ligament and medial third of the cardinal ligaments are then divided up to the level of the vaginal wall and the upper 2 cm of the vagina are excised with the specimen. Surgical margins can be sent for frozen section if desired. The reconstructive phase is then performed: the vesicovaginal peritoneum is reapproximated to the rectal peritoneum, drains are placed retroperitoneally and the pelvic sidewalls are reperitonealized (some surgeons oppose reperitonealization on grounds that it predisposes to lymphocyte formation), and a suprapubic catheter is introduced.

LYMPHADENECTOMY It has become standard practice both for prognostic and possible therapeutic advantages to include total pelvic and, if indicated, periaortic lymphadenectomies at the time of radical hysterectomy. Whether the lymphadenectomy is performed before or after the removal of the uterus varies per the surgeon. Pros and cons exist for both approaches. In any case, there has been increased interest during the last 20 years in staging formally the lymphatic involvement to better determine the value of postoperative extended field radiation therapy and the need for other treatments directed at advanced disease (surgically proven). Lymphatic metastases are believed to be embolic because intervening lymphatic tissue is often not involved and the lymphatic drainage generally is well established, pelvic to periaortic nodes and beyond. Pelvic lymphadenectomy is performed when the retroperitoneal spaces are developed and typically entails the removal of all fatty and lymphatic tissue from the iliac vessels extending from the bifurcation of the common iliac artery to the deep circumflex iliac artery distally. The dissection includes removing the fat pad overlying the fascia of the psoas muscle and obturator nerve, excising lymphatic tissue from the external iliac artery and vein (sparing the genitofemoral nerve), and clearing the obturator fossa between the obturator nerve and the obliterated hypogastric artery. Lymphatic tissue and fat deep to the obturator also can be taken along with ligation of the obturator artery and vein, but care must be taken to avoid hemorrhage. If the pelvic nodes are positive for disease, the common iliac nodes must be dissected.

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COMPLICATIONS

As is true with any radical surgery, the morbidity associated with radical hysterectomy depends on the surgeon's technique, the preoperative condition of the patient, history of previous radiation or pelvic surgery, the extent of disease, type of radical hysterectomy, and postoperative care. There are, however, specific problems related to radical hysterectomy and pelvic lymphadenectomy. In general, one in seven patients experience a major complication, and 1 in 330 have a fatal outcome. Patient age more than 65- although possibly associated with an increased intraoperative blood loss, increased frequency of immediate postoperative complications, and longer hospital stay- has not been associated with increased long-term morbidity or survival.33 As might be expected, Photopulos and Zwaag35 reported the advantage of modified radical or class II hysterectomy by demonstrating shorter operating time, shorter hospital stay, decreased fistula formation, and quicker return to normal bladder function. The most common intraoperative complication is hemorrhage, with as many as two out of three patients requiring a transfusion. Other morbidity in descending order of frequency includes injury to major vessels, the bladder, the ureter, the obturator nerve, and the rectum. Immediate postoperative complications include an increased incidence of deep venous thrombosis approximating 25%, 48 ureteral stricture and fistula formation, lymphocyst formation, and bladder dysfunction. Long-term morbidity can present with lower extremity lymphedema, bowel obstruction, and a foreshortened vagina, which leads to sexual dysfunction. Although nearly 75% of patients who undergo a Wertheim radical hysterectomy regain adequate bladder function within 1 to 2 weeks after surgery,8 stress and overflow incontinence, detrusor instability, and cystocele formation are commonly encountered long term but are usually resolvable, postoperative complications. The extent of the operation and the degree to which the cardinal and uterosacral ligaments and bladder pillars are resected determine the increased risk of these morbid sequelae. Direct injury to the sensory and motor innervation of the detrusor muscle with subsequent compromise of both the sympathetic and parasympathetic autonomic system can occur. Resulting bladder hypertonicity and hypotonicity therefore may be encountered; for this reason, suprapubic catheterization is performed routinely at the time of surgery for postoperative decompression and drainage. Ureteral injury was once a common complication of radical hysterectomy, with stricture and fistula formation complicating anywhere from 5% to 10% of all cases. Refinement in surgical technique and reduction in the incidence of lymphocyst formation have contributed to diminution of these complications that currently affect 1% to 3% of all cases. 13 With the dissection of the retroperitoneal spaces and standard pelvic lymphadenectomy, lymphocyst formation is a common complication of radical hysterectomy. Even with the introduction and routine use of percutaneous drainage catheters, lymphocyst formation may complicate anywhere from 5% to 30% of cases. Most are small, asymptomatic and selfresolving; some, however, can be extremely large and lead to life-threat-

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ening compression of the pelvic sidewall vessels and ureter, with resulting obstruction and sequelae that include lower extremity lymphedema, deep venous thrombosis, and ureteral obstruction. These must be drained under CT scan or ultrasonographic guidance. Another complication of radical hysterectomy is injury to the obturator nerve at the time of pelvic lymphadenectomy. Compromise of the obturator nerve, which supplies the adductor and gracilis muscles of the upper thigh, can result in failure to adduct the lower extremity. The more radical the hysterectomy, the higher the incidence of postoperative vaginal shortening and stricture, especially if adjuvant radiation therapy is used, and resulting sequelae of dyspareunia and decreased libido. If extensive surgical resection of the vagina is mandated by the extent of disease, then care should be taken at the time of reconstruction to augment vaginal length. Postoperative small bowel obstruction, which occurs on an average at 13 months from the time of surgery, can complicate 5% of nonradiated patients. This complication rate rises to 20% if patients undergo postoperative radiation. 31 RECURRENCE

Between 10% and 20% of patients treated with radical hysterectomy and pelvic lymphadenectomy for stage lb to Ila cervical cancer experience recurrence. Of these, 58% are detected within the first 12 months and 83% within the first 2 years.12•25 Those factors associated with a higher incidence of recurrence include larger lesions with evidence of lymphatic, hematologic or extracervical invasion, nodal metastasis, and adenosquamous carcinoma. Twenty-five percent experience recurrence locally in the upper vagina, but the pelvic side wall, central pelvis, and distant metastases involving the liver, lung, bone, and large bowel are also potential sites. Common signs and symptoms of recurrence are numerous with the ominous triad of weight loss, pelvic pain, and lower extremity edema, with partial to complete ureteral obstruction being the most common sign.7 Ultimate diagnosis must be confirmed histologically by biopsy. Treatment for unresectable, persistent, or recurrent disease is limited, with 1-year survival rates between 10% and 15%. PELVIC EXENTERATION

More than four decades have passed since Brunschweig introduced the first pelvic exenterative procedure for the palliative treatment of advanced and recurrent gynecologic cancer.5 The operation has undergone many modifications since 1948, and the indications for which it is currently performed have become more defined. These modifications, combined with better patient selection and advances in surgical technology, operative expertise, postoperative care, and rehabilitation have decreased the operative mortality rate from 23% to less than 5% and increased the 5-year survival rate from 17% to 41 % to 61 %. 6•32• 40 In Brunschweig's origi-

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nal operation, again based on the Halstedian concept of en bloc dissection, the pelvic viscera, including cervix, uterus, adnexa, bladder, rectosigmoid, and vagina, were resected and the ureters transplanted to the colon with subsequent formation of a "wet colostomy." Although the principle remains the same, refinements in vaginal reconstruction, bowel reanastamosis, and urinary diversion have made this ultraradical operation less morbid. It is currently considered a salvage operation to be performed less as a palliative than as a curative procedure. Pelvic exenteration is usually reserved for those patients with histologically confirmed postradiation recurrence or persistent vaginal, cervical, vulvar, and occasionally ovarian and uterine carcinoma located centrally in the pelvis. Other indications may include stage IVa cervical cancer, malignant vesicovaginal fistula, adenocarcinoma or melanoma of the urethra, and carcinoma of the sigmoid colon, rectum, and bladder. Of all indications, recurrent cervical carcinoma is the most common. Although usually performed as a secondary treatment for persistent disease after radiation therapy, exenteration also may be indicated, albeit rarely, as the primary intervention. Appropriate patient selection is the best predictor of postoperative outcome after exenterative surgery. Preoperative evaluation for clinical evidence of metastatic disease combined with diagnostic testing using CT, intravenous pyelogram lymphangiography, and guided fine-needle biopsy of suspicious lesions or nodes should be considered on all patients. The well-known triad of sciatic pain, lower extremity edema, and ureteral obstruction suggests unresectability, and the presence of multiple pelvic nodes or pelvic sidewall involvement is an absolute contraindication to surgery. Several authors have reported the importance of tumor type, histologic appearance, and biologic characteristics of the malignancy. Poor outcome has been associated with poorly differentiated cervical tumors and adenocarcinoma.24,32 In general, incurability as represented by the presence of distant metastases, extrapelvic lymph node involvement, or pelvic wall or bone invasion is regarded as a contraindication to exenterative procedures, Other relative contraindications include minimal nodal disease, poor cardiopulmonary status, systemic disease, and substantial obesity. The contraindications to exenterative procedures recently have been reviewed and the efficacy of palliative exenteration explored. It is generally accepted that patients with either persistent nodal disease after radiation therapy or gross residual disease after exenteration fare poorly, with mean survival rates being less than 1 year, Of those patients who are explored for possible exenterative procedures, 30% to 50% are unresectable, Nevertheless, and certainly controversial, several authors suggest a role for palliative exenteration for alleviation of pain in unresectable disease,33,47

THE TYPES OF EXENTERATION

Exenterations are defined by what organs are removed and the margin of resection with respect to the levator ani muscles. All exenterations

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include the resection of the cervix, uterus, parametria, paravaginal and uterosacral ligaments, adnexa, and pelvic nodes. In anterior exenteration, indicated for small cervical and anterior vaginal wall lesions, the bladder and distal ureters are excised and, if there is involvement of the lower half of the vagina, concurrent resection of the adjacent levator muscles is required. In posterior exenteration, typically indicated for cervical or vaginal cul-de-sac, the operation is essentially a combination of the MeigsOkabayashi radical hysterectomy, total vaginectomy, and concurrent rectosigmoid resection. Total exenteration combines the two (Fig. 2). Additionally, the surgical margins can be extended to include additional anatomic resection of the levator ani muscles themselves, partial or complete resection of the vulva, lymphadenectomy, or partial pubectomy. In 1990, Magrina28 published a proposed classification system to describe better the degree of resection. Depending on the pelvic viscera resected, four general exenterative categorizations have since been used: anterior, posterior, total, and extended. Because the procedure must be tailored to the extent of the disease encountered, subgroups were devised with respect to the level of resection of the pelvic viscera, levator muscles, urogenital diaphragm, and pelvic muscles. Supralevator or type I exenterations are indicated for upper cervicovaginal lesions for which only resection about or at the level of the levator muscle is required for complete tumor removal. In this procedure, the levator ani, urogenital diaphragm, and vulvoperineum are left undisturbed, thus reducing blood loss and simplifying reconstruction. The infralevator or type II exentera-

Figure 2. Sagittal cross-section of a total pelvic exenteration. Left to right: rectum, uterus, cervix and vagina, and the bladder.

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tion is indicated for lesions located in the middle or lower vagina for which resection of the levator muscles and partial resection of the urogenital diaphragm and vulvoperineum at the level of the urethral meatus, vaginal introitus, or lower anal canal is required. The exenteration with concurrent vulvectomy or type III is indicated for vulvovaginal lesions that require the resection of the levator ani muscles, urogenital diaphragm, and vulvoperineum and subsequent extensive reconstruction. 28 The last 20 years have shown great strides in the improvement and preservation of gastrointestinal, urinary, and sexual function in patients who undergo exenterative procedures. Advances in surgical stapling instrumentation have made possible low rectal resections and primary reanastomosis in cases that previously would have required a colostomy. Additionally, the advances in surgical technology have decreased significantly operative time, blood loss, and operative complications. 46 OUTCOME

As with radical hysterectomy, further and more accurate patient selection occurs intraoperatively when the abdomen and pelvis are explored. Tactile and visual findings consistent with extrapelvic lymphatic involvement or metastatic disease lead to termination of the operation. After this inspection, the retroperitoneal spaces are opened to evaluate the pelvic sidewall involvement; if positive, the surgery is generally abandoned. As a large series from M.D. Anderson Hospital showed, the 3-year survival rate for patients with positive margins and sidewall involvement is only 22% 42 and attempted pelvic wall resection is not associated with improved outcome. 44 However, promising preliminary data by Hockel and Knapstein18 looking at radical resection of pelvic sidewall disease followed by high-dose postoperative brachytherapy may change this premise. If contiguous pelvic peritoneal involvement is discovered, a decision must be made concerning its complete resectability. If the lesion can be included completely in the en bloc resection, significant salvage therapy may be rendered. The extent of pelvic node involvement and its influence on prognosis are of concern. The presence of multiple positive pelvic nodes reduces long-term survival. Indeed, the value of an exenterative procedure is questionable.2 However, if there is only microscopic lymph node involvement, long-term survival can be much better. As Stanhope and Symmonds47 observed in their series of patients with microscopic pelvic nodal disease, 5-year survival rate was 23%. Thus, the presence of microscopic pelvic node disease should not be considered an absolute contraindication to exenteration. URINARY DIVERSIONS

One of the most challenging problems in radical pelvic surgery has centered around the surgical approaches to urinary diversion, ranging

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from a simple percutaneous nephrostomy to a complex continent ileocolic urinary reservoir. The common theme is the preservation of renal function and, whenever possible, the preservation of existing anatomy. Historically, cutaneous forms of intestinal urinary diversion were developed in response to the high complication rate in terms of stricture and calculi surrounding cutaneous ureterostomies. In 1911, Coffey,9 by designing a nonrefluxing ureterocolonic anastomosis, refined the original ureterosigmoidostomy described by Simon in 1852. The uretero-ileal loop introduced by Bricker in 1950 and later modified by Leadbetter marked a turning point in the advancement of pelvic exenteration. At the same time, Gilchrist developed the ileocecal continent reservoir that used the ileocecal valve, antiperistaltic action of the ileum, and intermittent catheterization to provide continence. In part because of its technical difficulty, continent urinary reservoirs did not become popular until the 1970s. Rather, variations on Bricker's original work popularized cutaneous urinary ileal and colonic conduits. Indicated in anterior and total exenterations, persistent vesicovaginal fistula in radiated tissue, and unresectable carcinoma, the ileal conduit became the procedure of choice for cutaneous intestinal urinary diversion. Improvements in ureteroanastomosis and stoma formation using the Turnball technique significantly reduced the operative and postoperative complication rate. If the ileum cannot be used, other segments of small and large bowel, ideally unradiated, have been used with varying results. The jejunal conduit, indicated when high uretero and pyeloenteroanastomoses are required, is seldom used because of its association with significant electrolyte abnormalities related to the reabsorption of potassium and urea and excretion of sodium and chloride into the urine. The transverse colon also has been used for urinary conduits in patients who are extremely obese or who have foreshortened ureters. Usually this procedure requires mobilization of either the hepatic or splenic flexure and the resection of approximately 15 cm of transverse colon to which an end-toside ureteral anastomosis is performed. Sigmoid colon has been used rarely because it is often radiated and its use significantly shortens the colon, making a low rectal anastomosis even more difficult. Continent urinary reservoirs have replaced ileal and colonic conduits at many institutions. Improvements in continent urinary diversion accompanied by favorable results have made this approach the procedure of choice in the carefully selected patient population. Patients most suitable for this type of procedure include motivated individuals with no history of intrinsic bowel disease or prior radiotherapy. In essence, approaches in continent urinary diversion have attempted to simulate the bladder by the creation of a nonabsorbing, high-volume, low-pressure storage vesicle that prevents reflux and allows easy catheterization. Various pouches have been developed over the last two decades, and their names-Indiana, Mainz, Florida-are synonymous with their inherent variations. In 1982, Kock et al23 designed a continent ileal reservoir for cutaneous urinary diversion from detubularized ileum that used both an afferent nipple to prevent reflux and an efferent nipple to provide continence through self-catheterization by way of an abdominal stoma. Detubulari-

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zation of the ileum prevented the problematic pressure spikes seen with previous reservoirs. 23 Subsequently modified by Skinner et al, 45 this operation is technically difficult and time consuming and is usually indicated when the colon is not suitable, either because of inflammatory bowel disease or foreshortened ureters, for pouch formation. Results have been promising, however, with average capacity between 600 and 1400 mL, a resting pressure of 6 cm of water, and a catherization frequency of roughly 6 hours. In contrast to the Kock ileal pouch, several ileocolic reservoirs have been developed that are technically less difficult to perform. In general, the entire right colon, including the cecum and part of the transverse colon, are mobilized and detubularized and a continence mechanism is brought about by plicating the ileal segment and implanting the ureters proximal to the cecum. In 1987, Rowland et al41 published their data on the Indiana continent urinary reservoir in which they described a detubularized ileocecal pouch, plicated terminal ileum, and tunneled ureteroanastomosis. In the same year, Lockhart27 described using the cecum and ascending and proximal right transverse colon for the reservoir with direct ureterocolic anastomosis and plication of the terminal ileum to provide continence. VAGINAL RECONSTRUCTION

Numerous approaches to vaginal reconstruction have been described over the years. The first reports of neovagina construction were by Wharton49 and Mcindoe and Bannister in 193830; currently, vaginal reconstruction in patients who desire preservation of sexual function is routinely performed at the time of exenteration. Ultimately, the goal is to recreate a functional vagina with a durable and pliable lining while minimizing trauma to the donor site. In 1976, McGraw et al29 published their experience of constructing neovaginas w ith bilateral gracilis myocutaneous flaps . Unfortunately, problems with continued innervation of the new vagina can be disconcerting to women during sexual function. Less than 10 years later, Berek et al4 reported a success rate of 88% in their experience with neovaginal construction using a split-thickness skin graft to line a cylindrical pocket composed of an omental J flap anteriorly and the rectocolo-reanastomosis posteriorly. Further experience in the use of split-thickness skin graft vaginoplasty at the University of Michigan Medical Center has resulted in satisfactory results, making this their procedure of choice in neovaginal construction. 3 Elaborating this technique, Wheeless 50 describes good results with a modification of the omental J flap in which he creates a neovagina from the omentum. Alternatively, Pursell et al3 8 have advocated the use of a distally based rectus abdominus myocutaneous flap for pelvic reconstruction of a neovagina or perineal defect at the time of exenteration. Although similar to the gracilis myocutaneous flap operation in providing revascularization and obliteration of endopelvic dead space, the use of the rectus abdominus

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myocutaneous flap has been promoted because of its low complication rate (flap loss), decreased operative time, and overall ease.38 In summary, reconstructive surgery, including the development of a neovagina for continued sexual function and psychological well-being, has come to play an important role in ultraradical pelvic surgery. Pelvic reconstruction, including the use of gracilis and rectus abdominus flaps, has contributed in reducing the operative mortality and morbidity associated with exenterative procedures. With the refinement and development of surgical approaches accompanied by advances in synthetic material design, the hope for further improvement in pelvic reconstructive surgery is high. COMPLICATIONS

Although operative mortality has been decreased to less than 5%, the overall complication rate remains high. The complications surrounding exenterative procedures are innumerable and depend in large part on the extent and radicalness of the surgery. Additionally, comorbidity, including nutritional status and history of previous pelvic radiation therapy, influences the complication rate. Most patients who undergo exenteration experience a complication, and half of these are considered major. Morrow and Curtin33 reviewed the type and frequency of complications related to pelvic exenteration from six large series. Average blood loss was approximately 3 L, and the most common complications included wound dehiscence (12%), pelvic sepsis (10%), intestinal leakage (8%), urinary fistula and obstruction (6%), small bowel obstruction (5%), and pulmonary embolus (1.5%). Because complications are related to the procedures undertaken, so should they be described. The extirpation of the pelvic viscera and resulting denuded pelvic floor predisposes patients to small bowel obstruction and formation of enteric fistula. Various preventive approaches, including the mobilization of omentum and peritoneum to serve as a pelvic carpet and synthetic absorbable mesh as a carpet lid, have been used with varying success. Bowel resection is often complicated by anastomotic breakdown, paralytic ileus, small and large bowel obstruction, and stomal necrosis. The various reconstructive techniques can be complicated by flap necrosis and prolapse of the neovagina. The complications surrounding the various types of urinary diversions can be described best in terms of early and late manifestations. Between 10% and 15% of patients who undergo urinary diversion incur some type of related postoperative complication. Five percent of urinary conduits are complicated by leakage of urine, usually at the site of the ureteral anastomosis, with possible subsequent sepsis, urinoma, or abscess formation. Excessive tension or postoperative mesenteric constriction predisposes conduits to infarction and stoma necrosis, and 20% of patients experience a postoperative pyelonephritis secondary to stasis and reflux. Late complications of urinary diversion include a 10% to 20% risk of developing stomal stenosis, herniation, retraction, or de-

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terioration of the peristomal skin. Ureteral stenosis occurs between 1.5% and 18.4% of the time17 and, if severe and untreated, can lead to renal compromise. The most common site of stenosis is at the ureterointestinal anastomosis, where infection and ischemia can be contributing factors. Other complications include both recurrent urinary tract infections and 5% to 10% incidence of superimposed acute pyelonephritis. If a posterior exenteration is performed, significant postoperative voiding dysfunction can be encountered. Ureteral calculi and electrolyte imbalances, most notably hyperchloremic acidosis, are also common. Several factors have been associated with higher complication rates. Prior radiation therapy has been demonstrated by several authors to be associated with poor wound healing and an increased incidence of serious gastrointestinal and genitourinary complications.11· 39 Exenterations that require urinary diversion have been associated with significant complications. Soper et al46 encountered a higher incidence of major complications in patients who underwent sigmoid and ileal conduit procedures compared with transverse colon conduit or posterior exenteration. Factors that have been shown to decrease the incidence of perioperative and postoperative complications include the use of omentum and peritoneum to cover a denuded pelvic floor and the use of myocutaneous flaps in pelvic reconstruction. 2M 2

WHY ULTRARADICAL PELVIC SURGERY?

Pelvic exenterative procedures are the only possible curative therapy for women with recurrent or persistent central pelvic malignancy after radiation therapy. During the last 20 years, a significant increase in longterm survival has been realized, in part because of better patient selection and because of decreased operative morbidity and mortality. Various innovations and improvements in both surgical technique and perioperative and postoperative management have made this possible. Nevertheless, the radical nature of pelvic exenteration continues to make this a highly morbid operation. Although operative mortality has decreased to less than 10%, operative morbidity in terms of life-threatening complications remains between 30% and 50%. 13•32• 46 The need to reoperate because of life-threatening complications remains high and the associated operative mortality with reoperation is significant. Although series have reported a reoperative mortality rate of 40% to 60%, some institutions have more promising results. 41 • 46 The 5-year survival rate after pelvic exenteration ranges between 20% and 60%. Survival depends on patient selection and the type of exenterative procedure being performed. Approximately 40% of patients who undergo exenteration are alive 5 years later. The most common site of recurrence is in the pelvis, with risk factors for recurrence including positive margins, nodal metastasis, pelvic wall involvement, and initial large tumor burden.

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References 1. Anderson B: Ovarian transposition in cervical cancer. Gynecol Oncol 40:206, 1993 2. Barber HRK, Hones WB: Lymphadenectomy in pelvic exenteration for recurrent cervix cancer. JAMA 2115:1945, 1971 3. Beemer W, Hopkins MP, Morely GW: Vaginal reconstruction in gynecologic oncology. Obstet Gynecol 72:911, 1988 4. Berek JS, Hacker Nf, Ligasse LD: Vaginal reconstruction performed simultaneously with pelvic exenteration. Obstet Gynecol 63:318, 1984 5. Brunschweig A: Complete excision of pelvis viscera for advanced carcinoma: A onestage abdominoperineal operation with end colostomy and bilateral ureteral implantation into colon about the colostomy. Cancer 1:177, 1948 6. Brunschweig A, Daniel WW: Pelvic exenteration operations. Ann Surg 151:571, 1960 7. Burke TW, Hoskins WJ, Heller PB, et al: Clinical patterns of tumor recurrence after radical hysterectomy in Stage lb cervical carcinoma. Obstet Gynecol 69:382-385, 1987 8. Chamberlain DH, Hopkins MP, Roberts JA, et al: The effect of early removal in dwelling urinary catheter after radical hysterectomy. Gynecol Oncol 43:98, 1991 9. Coffey RC: Physiologic implantation of the severed ureter or common bile duct into the intestine. JAMA 56:397, 1911 10. Creasman WT: Early invasive carcinoma of the cervix. Presented at the 25 Annual Meeting of the Society of Gynecologic Oncologists. Orlando, February 6- 9, 1994 11. Curry SL, Nahhas WA, Jahshan AE, et al: Pelvic exenteration: A 7-year experience. Gynecol Oncol 11:119, 1981 12. Dave K, Kapadia A: Retrospective evaluation of recurrence after radical hysterectomy in patients with cervical cancer. Eur J Gynaecol Oncol 11:67, 1990 13. Disaia PJ, Creasman WT: Clinical Gynecologic Oncology, ed 4. St. Louis, Mosby Year Book, 1993 14. FICO: Annual report on results of treatment in gynecological cancer. Int J Gynaecol Obstet 36 (suppl): 1, 1991 15. Fletcher GH, Rutledge FN: Extended field technique in the management of the cancers of the uterine cervix. AJR Am J Roentgenol 114:116, 1972 16. Gallion HH, van Nagell J Jr, et al: Combined radiation therapy and extrafascial hysterectomy in the treatment of stage lb barrel shaped cervical cancer. Cancer 56:262, 1985 17. Hancock KC, Copeland LJ, Gershenson DM, et al: Urinary conduits in gynecologic oncology. Obstet Gynecol 67:680, 1986 18. Hocke! M, Knapstein PG: The combined operative and radiotherapeutic treatment (CORT) of recurrent tumors infiltrating the pelvic wall: First experience with 18 patients. Gynecol Oncol 46:199, 1992 19. Inn T, Morita K: The prognostic significance of number of positive nodes in cervical carcinoma stages IB, Ha and IIlb. Cancer 65:1923, 1990 20. Inn T, Chihara T, Morita K: The prognostic significance of the size of the largest nodes in metastatic carcinoma from the uterine cervix. Gynecol Oncol 19:187, 1984 21. Johnson N, Lilford RJ, Jones SE, et al: Using decision analysis to calculate the optimum treatment for microinvasive cervical cancer. Br J Cancer 65:717, 1992 22. Kamura T, Tsukamoto N, Tsuruchi N, et al: A multivariate analysis of the histopathologic prognostic factors of cervical cancer in patients undergoing radical hysterectomy. Cancer 69:181, 1992 23. Kock NG, Nilson AE, Nilson LO, et al: Urinary diversion via a continent ilea! reservoir: Clinical results in 12 patients. J Urol 128:469, 1982 24. Kraybill WG, Lopez MJ, Bricker EM: Total pelvic exenteration as a therapeutic option in advanced malignant disease of the pelvis. Surg Gynecol Obstet 166:259, 1988 25. Krebs HB, et al: Recurrent cancer of the cervix following hysterectomy and pelvic node dissection. Obstet Gynecol 59:422, 1982 26. Lancey CG, Stern JL, Feigenbaum S, et al: Vaginal reconstruction after exenteration with use of gracilis myocutaneous flaps. Am J Obstet Gynecol 158:1278, 1988 27. Lockhart JL: Remodeled right colon: An alternative urinary reservoir. J Urol 138:730, 1987 28. Magrina JF: Types of pelvic exenteration: A reappraisal. Gynecol Oncol 37:363, 1990

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29. McGraw JB, Massey FM, Shanklin KD, et al: Vaginal reconstruction with gracilis myocutaneous flap. Plast Reconstr Surg 58:176, 1976 30. Mcindoe AH, Banister JB: An operation for the care of congenital absence of the vagina. Obstetrics and Gynecology of the British Empire 45:490, 1938 31. Montz FJ, Holschneider CH, Solh S, et al: Small bowel obstruction following radical hysterectomy: Risk factors, incidence and operative findings . Gynecol Oncol 53:114, 1994 32. Morley GW, Hopkins MJ, Lindenauer SM, et al: Pelvic exenteration, University of Michigan: 100 patients at 5 years. Obstet Gynecol 74:934, 1989 33. Morrow CP, Curtin JP: Gynecologic Cancer Surgery. New York, Churchill Livingstone, 1996 34. Parker M, Bosscher J, Barnhill D, et al: Ovarian management during radical hysterectomy in the premenopausal patient. Obstet Gynecol 82:187, 1993 35. Photopulos GJ, Zwaag RV: Class II radical hysterectomy shows less morbidity and good treatment efficacy compared to Class III. Gynecol Oncol 40:21, 1991 36. Piver S, Rutledge F, Smith JP: Five classes of extended hysterectomy. Am J Obstet Gynecol 44:265, 1974 37. Price JA: The early ovariotomists: Pioneers in abdominal surgery. Ulster Medical Journal 36:1, 1967 38. Pursell SH, Day TG, Tobin GR: Distally based rectus abdominus flaps for reconstruction in radical gynecologic procedures. Gynecol Oncol 37:234, 1990 39. Roberts WS, Cavanaugh D, Bryson SC, et al: Major morbidity after pelvic exenteration: A seven-year experience. Obstet Gynecol 69:617, 1987 40. Robertson G, Lopes A, Beynon G, et al: Pelvic exenteration: A review of the Gateshed experience 1974-1992. Br J Obstet Gynaecol 101:529, 1994 41. Rowland RG, Mitchell ME, Bihrle R, et al: Indiana continent urinary reservoir. J Urol 137:1136, 1987 42. Rutledge FN, Smith JP, Wharton JT, et al: Pelvic exenteration: Analysis of 296 patients. Am J Obstet Gynecol 121:881, 1977 43. Sartori E, Fallo L, Laface B, et al: Extended hysterectomy in early stage carcinoma of the uterine cervix: Treating the radicality. International Journal of Gynecologic Cancer 5:143, 1995 44. Shingleton HM, Soong S, Gelder MS, et al: Clinical and histopathologic factors predicting recurrence and survival after pelvic exenteration for cancer of the cervix. Obstet Gynecol 73:1027, 1989 45. Skinner DG, Lieskovsky G, Skinner EC, et al: Current Problems in Surgery: Urinary Diversion. Chicago, Year Book Medical Publishers, 1987 46. Soper JT, Berchuck A, Creasman WT, et al: Pelvic exenteration: Factors associated with major surgi..:al morbidity. Gynecol Oncol 35:93, 1989 47. Stanhope CR, Symmonds RE: Palliative exenteration: What, when and why? Am J Obstet Gynecol 152:12, 1985 48. Walsh JT, Bonner J, Wright FW: A study of pulmonary embolus and deep leg vein thrombosis after major gynecological surgery using labeled fibrinogen phlebography and lung scanning. Journal of Obstetrics and Gynecology of the British Commonwealth 81 :311, 1974 49. Wharton LR: A simple method of constructing a vagina: Report of four cases. Ann Surg 107:842, 1938 50. Wheeless CR: Neovagina constructed from an omental J flap and a split-thickness skin graft. Gynecol Oncol 35:224, 1989 51. Wiggins DL, Granai CO, Steinhoff MM, et al: Tumor angiogenesis as a prognostic factor in cervical carcinoma. Gynecol Oncol 56:353, 1995 52. Zander J, et al: Carcinoma of the cervix: An attempt to individualize treatment. Results of a 20-year cooperative study. Am J Obstet Gynecol 139:752, 1981

Address reprint requests to Hector M. Tarraza, MD, FACOG, FACS Professor and Chairman Department of Ob/Gyn Maine Medical Center 22 Bramball Street Portland, ME 04102