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Modified laparoscopic sacrocolpopexy with mesh for severe pelvic organ prolapse
International Journal of Gynecology and Obstetrics 121 (2013) 170–172
Contents lists available at SciVerse ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Modified laparoscopic sacrocolpopexy with mesh for severe pelvic organ prolapse Lan Zhu ⁎, Zhixing Sun, Mei Yu, Bin Li, Xiaochuan Li, Jinghe Lang Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China
a r t i c l e
i n f o
Article history: Received 23 July 2012 Received in revised form 24 November 2012 Accepted 14 January 2013 Keywords: Clinical outcome Mesh Pelvic organ prolapse Sacrocolpopexy Severe
a b s t r a c t Objective: To evaluate anatomic and sexual outcomes among patients with severe pelvic organ prolapse, defined as stage III or higher by Pelvic Organ Prolapse Quantification (POP-Q), who underwent modified laparoscopic sacrocolpopexy. Methods: Between March 2007 and December 2010, a prospective study in Beijing, China, enrolled 21 patients who underwent vaginal hysterectomy, followed by modified laparoscopic sacrocolpopexy with the attachment of mesh straps transvaginally and the sacral attachment of mesh laparoscopically. Patients were assessed at 6 weeks, 6 months, and yearly. Anatomic success was defined as POP-Q lower than stage II. Sexual outcomes were assessed via the short-form Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Results: During a median follow-up of 43.5 months (range 18–60 months), the surgical success rate was 100%, the patient satisfaction rate was 90.4%, and 1 patient (4.8%) experienced mesh exposure. Postoperatively, 20 patients were sexually active (95.2%). There was a significant improvement between pre- and postoperative PISQ-12 scores both for the total score (31.6 vs 38.5; P b 0.001), and for 5 individual items (Pb 0.01). Conclusion: Modified laparoscopic sacrocolpopexy with mesh seemed to be safe and might simplify the surgical approach to severe POP with satisfying anatomic and functional outcomes. It did not affect sexual function negatively. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction
2. Materials and methods
For women with severe pelvic organ prolapse (POP) who have borne children, the main aim of treatment is to preserve sexual function with a high rate of surgical success. Recent studies [1,2] have focused on finding an effective surgical procedure that results in fewer recurrent prolapses and has less effect on sexual function. Sacrocolpopexy provides one of the highest cure rates for POP, ranging from 74% to 98% [1,3], and causes less impairment of sexual function compared with total pelvic floor reconstruction with mesh. For these reasons, it remains the classical approach for the treatment of women with severe POP who wish to preserve sexual function. Laparoscopic sacrocolpopexy (LSC) is reported to offer good clinical results similar to those of abdominal sacrocolpopexy [2], with the added benefit of being minimally invasive. However, LSC is a lengthy procedure with an average operating time of 158 minutes [4], which is the main limitation of this approach. The aim of the present study was to evaluate the anatomic and sexual function outcomes, in addition to the complications, of a modified approach to LSC using mesh among women affected with severe POP.
In a prospective study at the Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Beijing, China, patients who had a clinical diagnosis of severe POP and who underwent modified LSC with mesh were enrolled between March 1, 2007, and December 31, 2010. Informed consent was obtained from all patients, and ethics approval was obtained from the Ethics Committee of Peking Union Medical College Hospital prior to performing the first surgical procedure. All of the study participants had borne children and were not planning to bear any more. In addition, all patients met the following entry criteria: diagnosis of stage III or higher POP by Interactive Pelvic Organ Prolapse Quantification (POP-Q) [5]; no preoperative urinary incontinence (evaluated by history); age younger than 60 years; and no hemorrhagic disease or blood coagulation disorder. Women who could not tolerate the laparoscopic procedures were excluded from the study. A single surgeon (L.Z.) carried out all of the operations as follows. The patient was placed in a lithotomy position under intravenous anesthesia. For those who still had a uterus, vaginal hysterectomy was performed routinely before the modified LSC. The modified LSC was divided into 2 stages: the transvaginal part and the laparoscopic part. In the transvaginal part of the operation, a hydro-dissection (via the injection of 40–60 mL of physiologic saline and 1:200 000 of angiotensin into the vaginal submucosa of the vesicovaginal and rectovaginal space, respectively) was performed to create 2 newly
⁎ Corresponding author at: Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China, 100730. Tel.: +86 10 65296784, +86 10 13911714696; fax: +86 10 65124875. E-mail address: [email protected] (L. Zhu).
0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2012.11.016
L. Zhu et al. / International Journal of Gynecology and Obstetrics 121 (2013) 170–172
dissected anterior and posterior vaginal walls, each 3.5 cm by 3.0 cm, closest to the vaginal vault. A polypropylene mesh (GyneMesh 10 cm × 15 cm; Ethicon, Somerville, NJ, USA) was pre-cut into 2 strips of 3.5 cm in width. Nine interrupted sutures (3 sutures in 3 rows with a spacing of 1 cm) using 7-0 silk (Mersilk; Ethicon) were placed through the meshes and into the dissected anterior and posterior vaginal walls to secure the meshes. Notably, the sutures did not traverse the whole vagina mucosa layer. The excess anterior mesh was excised at the vault, and the excess posterior mesh was placed in the pelvic cavity. Thereafter, the 2 segments of anterior and posterior meshes (which were previously sutured onto the dissected anterior and posterior vaginal walls) were attached by using interrupted suturing with 7-0 silk at the vaginal vault. By contrast, continuous, absorbable sutures (1/0 Vicryl; Ethicon) were used to attach the anterior to the posterior vagina mucosa, under which the meshes were placed. For the laparoscopic part of the operation, the right paracolic sulci were exposed under a laparoscope. The peritoneum covering the sacral promontory was opened, and the right ureter was visualized by using blunt dissection. Laterally, the presacral region was opened to identify the avascular surgical planes. Next, the peritoneal incision, immediately right of the midline, was continued down the right uterosacral ligament to reach the vaginal vault. The vaginal vault was lifted up by the assistant using oval forceps that were wrapped with sponges. Under a laparoscope, the mesh was measured from the vaginal vault to the sacral promontory to determine the desired length, and the necessary trimming was done. The distal end of the mesh was interrupted sutured and fixed to the anterior longitudinal ligament at the sacral promontory with a total of 3 non-absorbable sutures (Ethibond; Ethicon). A vaginal examination was performed with fingers to ensure the POP-Q measurement for POP-Q point C was − 8 cm to − 10 cm after suspension. The parietal peritoneum was then closed to end the surgical procedure. General patient characteristics were collected from the chart before the women were discharged, and the information was verified and input into a computer database. Both the anatomic and sexual assessments were conducted by examiners in the Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, who were blind to other study data. Anatomic results were evaluated for pelvic organ support at 6 weeks, 6 months, and 12 months after surgery, and then yearly via the standardized POP-Q technique. Surgical success for the anterior and posterior segments was defined as POP-Q stage I or lower, as recommended by the NIH Standardization Workshop [6]. Patient satisfaction was determined by a quality-of-life questionnaire. Sexual outcomes were assessed at 6 months after surgery and then yearly via the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The follow-up rate was 100%, and the most recent measurements for each patient were reported in the study. A paired t test was used to compare the means of variables with normal or approximately normal distributions (the Shapiro–Wilk test was used to determine the distribution of population), and Wilcoxon rank-sum test was used to compare pre- and postoperative total PISQ-12 scores. All analyses were done via SPSS version 16.0 (IBM, Armonk, NY, USA). For all tests, a P value of less than 0.05 was taken to be significant.
3. Results During the study period, 21 patients had modified LSC with mesh and were enrolled in the study. All participants had stage III or higher POP-Q. The age range of the study group was 32–54 years, and the mean was 41.5 years. Gravidity ranged from 2 to 5 (mean, 3.2), and parity ranged from 1 to 4 (mean, 1.9). No patient was excluded from the analysis.
171
Table 1 Pre- and postoperative POP-Q measurements.a Measurement
Preoperative, cm
Postoperative, cm
P valueb
Aa Ba C GH PB TVL Ap Bp
1.5 ± 1.9 1.1 ± 2.8 3.4 ± 1.3 5.6 ± 1.0 2.4 ± 0.5 7.7 ± 0.9 1.8 ± 3.5 0.9 ± 4.1
−2.5 ± 0.5 −2.6 ± 0.9 −8.9 ± 0.7 4.4 ± 0.7 3.9 ± 0.5 9.6 ± 1.1 −2.1 ± 0.5 −2.8 ± 0.7
b0.01 b0.01 b0.001 b0.05 b0.05 b0.01 b0.01 b0.05
a b
Values are given as mean± SD unless stated otherwise. By paired t test comparing pre- and postoperative POP-Q measurements.
The mean operating time was 95.6 minutes (range, 85–150 minutes), and the mean blood loss was 147 mL. No intraoperative complications such as injuries or hemorrhage occurred; the postoperative febrile morbidity (defined as “2 oral temperatures higher than 38 °C, taken at least 4 hours apart starting 24 hours after the operation” [7]) was 4.8% (1/21). Over the median follow-up time of 43.5 months (range, 18– 60 months), the surgical success rate was 100%. Objective assessment demonstrated that the POP-Q score for each patient improved significantly compared with the preoperative value (Table 1). Postoperatively no patient had symptomatic prolapse, and all patients had good apical anatomic support. Subjectively, approximately 90.4% of the patients thought that their operation was “very successful,” and 95.2% considered themselves “much better” than before the operation. Three months after surgery, 20 of 21 patients (95.2%) were sexually active. According to the PISQ-12 score, there was a significant improvement in total PISQ-12 score and in 5 individual PISQ-12 items (sexual excitement, sexual desire, avoidance of intercourse because of prolapse, negative emotional reactions during sexual activity, and comparison of orgasmic level between the past and the present) (Table 2). Six months after surgery, 1 patient (4.8%) developed stress urinary incontinence (SUI), and 1 patient (4.8%) experienced exposure of approximately 3 cm by 2 cm of mesh at the vaginal vault, which required transvaginal surgical excision of the exposed mesh and vaginal mucosa suturing under intravenous anesthesia. Six months after repair, gynecologic examination indicated that the mucosa of the vaginal vault was completely normal. The patient was followed for another 2 years, and recurrent prolapse did not occur. 4. Discussion Abdominal sacrocolpopexy is an operation that lifts the prolapsed vagina back up to its normal position by attachment of a synthetic mesh from the top and back of the vagina to the ligaments of the sacrum.
Table 2 Pre- and postoperative PISQ-12 results.a Item
Preoperative score
Postoperative score
Mean improvement, percentage
P valueb
Total score Sexual excitement Sexual desire Avoidance of intercourse due to prolapse Negative emotional reactions during sexual activity Comparison of orgasmic level between past and present
31.6 ± 3.2 2.1 ± 0.7 1.7 ± 0.6 1.5 ± 1.4
38.5 ± 3.9 2.5 ± 0.7 2.4 ± 0.8 3.4 ± 0.8
21.9 16.7 38.2 123.3
b0.001 b0.01 0.001 0.001
1.1 ± 1.0
3.1 ± 0.8
195.2
b0.001
1.1 ± 0.6
2.7 ± 0.6
131.8
b0.001
Abbreviation: PISQ, Prolapse/Urinary Incontinence Sexual Questionnaire. a Values are given as mean± SD unless stated otherwise. b By Wilcoxon rank-sum test comparing pre- and postoperative PISQ-12 scores.
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L. Zhu et al. / International Journal of Gynecology and Obstetrics 121 (2013) 170–172
With a success rate of 74% to 98% [1,3], abdominal sacrocolpopexy has long been regarded as the gold standard procedure for the treatment of POP. Sacrocolpopexy involves vaginal suspension from several sites. Meshes can be attached to the vaginal vault, the mid-anterior and posterior vaginal walls, or the perineal body, and are then suspended to the sacral promontory. Attaching meshes to the vaginal vault, which might not provide enough support, leads to easy tears that can result in failure of the repair. Inserting meshes deep into the perineal body, with the anterior strip placed behind of the trigone of bladder, should also be avoided to decrease the risk of hemorrhage and detrusor instability after surgery. In addition, the effect on sexual function of attaching meshes to the perineal body remains unknown. As a result, the meshes were inserted into the superior third of the anterior and posterior vaginal walls in the present study. In 1994, Nezhat et al. [8] reported the first instance of using LSC to manage POP, in which the prolapsed vaginal vault was attached to the anterior longitudinal ligament of the sacrum over the third and fourth sacral vertebrae using mesh. Subsequently, operational difficulties prompted some surgeons to attach the vaginal vault to the anterior longitudinal ligament of the sacral promontory [9,10], leading to a satisfactory success rate similar to that for abdominal sacrocolpopexy [2]; however, this procedure requires agility with laparoscopic suturing and, thus, lengthens the operating time. Ganatra et al. [4] reviewed several studies on LSC and concluded that the mean operating time was 158 minutes, leading to a bottleneck in the development of LSC. In the present study, part of the procedure was carried out via the transvaginal route, which greatly simplified the suturing procedure with the laparoscope. The mean operating time was 95.6 minutes, which is much shorter than the reported average of 158 minutes. In addition, over the median follow-up time of 43.5 months, the rates of patient satisfaction and objective success were 90.4% and 100%, respectively. The reduced operating time, coupled with adequate clinical results, make this modified LSC approach more feasible. Historically, few studies have contrasted sexual function before and after POP operations. According to a pooled analysis [4], assessment of postoperative sexual function outcomes in 8 studies found that 7.8% (range, 0%–47%) of patients had sexual dysfunction after LSC. At present, the PISQ is the only validated sexual function questionnaire (i.e. with level B evidence, and recommended by the ICS) for women with POP. The present study used PISQ-12, which contained 12 questions selected from the long form [11]. All patients except 1 (because of mesh exposure) were postoperatively sexually active, with a dyspareunia rate of 4.8%. For the 20 patients who were sexually active after surgery, the total PISQ-12 score and 5 individual PISQ-12 items (sexual excitement, sexual satisfaction, avoidance of intercourse, negative emotional reactions, and orgasmic level) improved significantly, which is an advantage of the present approach. The main factor that affects sexual function negatively might be mesh exposure, which usually occurs in the first 3–36 months after operation [12,13]. The incidence of vaginal mesh exposure has been reported to vary from 3% to 14% among patients treated by sacrocolpopexy [13,14]. In a study of 402 patients who were followed for 12 months, Stepanian et al. [15] found that women who underwent concurrent hysterectomy during sacrocolpopexy had a mesh exposure rate of 2.3%, compared with 0.7% of women with a history of previous hysterectomy who underwent sacrocolpopexy. Because both incidences of mesh exposure were very low, however, they found no significant difference (P = 0.18) in the risk of mesh-related complications. In the present study, concurrent hysterectomy was carried out before the meshes were transvaginally attached and sutured to the vaginal vault to reduce the difficulty of the operation under the laparoscope. The mesh exposure rate of 4.8% (1/21), which is slightly high owing to the small sample volume, seems acceptable; however, more prospective, high-powered trials are needed to confirm these results.
Intraoperative complications of sacrocolpopexy that have been reported include injuries to the bladder, ureters, or bowel, and hemorrhage owing to injuries to the venous plexus of the presacral region. In general, these severe complications have a low incidence, and no intraoperative complications occurred in the present study. Postoperative complications, by contrast, include SUI, urinary tract infection, urinary retention, bowel dysfunction, and mesh exposure or extrusion. According to the pooled analysis by Ganatra [4], 17.8% (range, 2.4%–44%) of patients treated by LSC had SUI, urinary urgency, or urinary retention postoperatively, whereas postoperative bowel dysfunction such as constipation, anal pain, and fecal incontinence occurred in 9.8% (range, 0%–25%) of the patients. In the present study, 1 patient (4.8%) developed postoperative SUI. No other complications were observed, which may be due to the small sample volume. The present assessment had some limitations. First, the number of patients was small and the patients were evaluated over a short period of time. Second, owing to the sample size, it was not possible to have 2 study groups to compare the risk of mesh exposure between patients who underwent concurrent hysterectomy at the time of sacrocolpopexy and those with a history of previous hysterectomy. Third, in terms of evaluating sexual outcomes, the study design did not include a control group, which therefore prevented statistical analyses between groups because all of the patients were exposed to surgical intervention. In summary, modified LSC with mesh was found to be a simple and safe procedure for the treatment of severe POP, and it did not seem to interfere with sexual function. A prospective controlled trial with a larger patient sample and a longer follow-up period would confirm the present results. Conflict of interest The authors have no conflicts of interest. References [1] Hilger WS, Poulson M, Norton PA. Long-term results of abdominal sacrocolpopexy. Am J Obstet Gynecol 2003;189(6):1606–10. [2] Rozet F, Mandron E, Arroyo C, Andrews H, Cathelineau X, Mombet A, et al. Laparoscopic sacral colpopexy approach for genito-urinary prolapse: experience with 363 cases. Eur Urol 2005;47(2):230–6. [3] Occelli B, Narducci F, Cosson M, Ego A, Decocq J, Querleu D, et al. Abdominal colposacroplexy for the treatment of vaginal vault prolapse with or without urinary stress incontinence. Ann Chir 1999;53(5):367–77. [4] Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, et al. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol 2009;55(5):1089–103. [5] Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175(1):10–7. [6] Barber MD, Brubaker L, Nygaard I, Wheeler II TL, Schaffer J, Chen Z, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 2009;114(3):600–9. [7] Ghezzi F, Franchi M, Buttarelli M, Serati M, Raio L, Maddalena F. The use of suction drains at burch colposuspension and postoperative infectious morbidity. Arch Gynecol Obstet 2003;268(1):41–4. [8] Nezhat CH, Nezhat F, Nezhat C. Laparoscopic sacral colpopexy for vaginal vault prolapse. Obstet Gynecol 1994;84(5):885–8. [9] Cosson M, Rajabally R, Bogaert E, Querleu D, Crépin G. Laparoscopic sacrocolpopexy, hysterectomy, and burch colposuspension: feasibility and short-term complications of 77 procedures. JSLS 2002;6(2):115–9. [10] Ross JW. Techniques of laparoscopic repair of total vault eversion after hysterectomy. J Am Assoc Gynecol Laparosc 1997;4(2):173–83. [11] Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct 2003;14(3):164–8. [12] Higgs PJ, Chua HL, Smith AR. Long term review of laparoscopic sacrocolpopexy. BJOG 2005;112(8):1134–8. [13] Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol 2008;199(6):688.e1–5. [14] Visco AG, Weidner AC, Barber MD, Myers ER, Cundiff GW, Bump RC, et al. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol 2001;184(3):297–302. [15] Stepanian AA, Miklos JR, Moore RD, Mattox TF. Risk of mesh extrusion and other mesh-related complications after laparoscopic sacral colpopexy with or without concurrent laparoscopic-assisted vaginal hysterectomy: experience of 402 patients. J Minim Invasive Gynecol 2008;15(2):188–96.
Contents lists available at SciVerse ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Modified laparoscopic sacrocolpopexy with mesh for severe pelvic organ prolapse Lan Zhu ⁎, Zhixing Sun, Mei Yu, Bin Li, Xiaochuan Li, Jinghe Lang Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China
a r t i c l e
i n f o
Article history: Received 23 July 2012 Received in revised form 24 November 2012 Accepted 14 January 2013 Keywords: Clinical outcome Mesh Pelvic organ prolapse Sacrocolpopexy Severe
a b s t r a c t Objective: To evaluate anatomic and sexual outcomes among patients with severe pelvic organ prolapse, defined as stage III or higher by Pelvic Organ Prolapse Quantification (POP-Q), who underwent modified laparoscopic sacrocolpopexy. Methods: Between March 2007 and December 2010, a prospective study in Beijing, China, enrolled 21 patients who underwent vaginal hysterectomy, followed by modified laparoscopic sacrocolpopexy with the attachment of mesh straps transvaginally and the sacral attachment of mesh laparoscopically. Patients were assessed at 6 weeks, 6 months, and yearly. Anatomic success was defined as POP-Q lower than stage II. Sexual outcomes were assessed via the short-form Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Results: During a median follow-up of 43.5 months (range 18–60 months), the surgical success rate was 100%, the patient satisfaction rate was 90.4%, and 1 patient (4.8%) experienced mesh exposure. Postoperatively, 20 patients were sexually active (95.2%). There was a significant improvement between pre- and postoperative PISQ-12 scores both for the total score (31.6 vs 38.5; P b 0.001), and for 5 individual items (Pb 0.01). Conclusion: Modified laparoscopic sacrocolpopexy with mesh seemed to be safe and might simplify the surgical approach to severe POP with satisfying anatomic and functional outcomes. It did not affect sexual function negatively. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction
2. Materials and methods
For women with severe pelvic organ prolapse (POP) who have borne children, the main aim of treatment is to preserve sexual function with a high rate of surgical success. Recent studies [1,2] have focused on finding an effective surgical procedure that results in fewer recurrent prolapses and has less effect on sexual function. Sacrocolpopexy provides one of the highest cure rates for POP, ranging from 74% to 98% [1,3], and causes less impairment of sexual function compared with total pelvic floor reconstruction with mesh. For these reasons, it remains the classical approach for the treatment of women with severe POP who wish to preserve sexual function. Laparoscopic sacrocolpopexy (LSC) is reported to offer good clinical results similar to those of abdominal sacrocolpopexy [2], with the added benefit of being minimally invasive. However, LSC is a lengthy procedure with an average operating time of 158 minutes [4], which is the main limitation of this approach. The aim of the present study was to evaluate the anatomic and sexual function outcomes, in addition to the complications, of a modified approach to LSC using mesh among women affected with severe POP.
In a prospective study at the Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Beijing, China, patients who had a clinical diagnosis of severe POP and who underwent modified LSC with mesh were enrolled between March 1, 2007, and December 31, 2010. Informed consent was obtained from all patients, and ethics approval was obtained from the Ethics Committee of Peking Union Medical College Hospital prior to performing the first surgical procedure. All of the study participants had borne children and were not planning to bear any more. In addition, all patients met the following entry criteria: diagnosis of stage III or higher POP by Interactive Pelvic Organ Prolapse Quantification (POP-Q) [5]; no preoperative urinary incontinence (evaluated by history); age younger than 60 years; and no hemorrhagic disease or blood coagulation disorder. Women who could not tolerate the laparoscopic procedures were excluded from the study. A single surgeon (L.Z.) carried out all of the operations as follows. The patient was placed in a lithotomy position under intravenous anesthesia. For those who still had a uterus, vaginal hysterectomy was performed routinely before the modified LSC. The modified LSC was divided into 2 stages: the transvaginal part and the laparoscopic part. In the transvaginal part of the operation, a hydro-dissection (via the injection of 40–60 mL of physiologic saline and 1:200 000 of angiotensin into the vaginal submucosa of the vesicovaginal and rectovaginal space, respectively) was performed to create 2 newly
⁎ Corresponding author at: Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China, 100730. Tel.: +86 10 65296784, +86 10 13911714696; fax: +86 10 65124875. E-mail address: [email protected] (L. Zhu).
0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2012.11.016
L. Zhu et al. / International Journal of Gynecology and Obstetrics 121 (2013) 170–172
dissected anterior and posterior vaginal walls, each 3.5 cm by 3.0 cm, closest to the vaginal vault. A polypropylene mesh (GyneMesh 10 cm × 15 cm; Ethicon, Somerville, NJ, USA) was pre-cut into 2 strips of 3.5 cm in width. Nine interrupted sutures (3 sutures in 3 rows with a spacing of 1 cm) using 7-0 silk (Mersilk; Ethicon) were placed through the meshes and into the dissected anterior and posterior vaginal walls to secure the meshes. Notably, the sutures did not traverse the whole vagina mucosa layer. The excess anterior mesh was excised at the vault, and the excess posterior mesh was placed in the pelvic cavity. Thereafter, the 2 segments of anterior and posterior meshes (which were previously sutured onto the dissected anterior and posterior vaginal walls) were attached by using interrupted suturing with 7-0 silk at the vaginal vault. By contrast, continuous, absorbable sutures (1/0 Vicryl; Ethicon) were used to attach the anterior to the posterior vagina mucosa, under which the meshes were placed. For the laparoscopic part of the operation, the right paracolic sulci were exposed under a laparoscope. The peritoneum covering the sacral promontory was opened, and the right ureter was visualized by using blunt dissection. Laterally, the presacral region was opened to identify the avascular surgical planes. Next, the peritoneal incision, immediately right of the midline, was continued down the right uterosacral ligament to reach the vaginal vault. The vaginal vault was lifted up by the assistant using oval forceps that were wrapped with sponges. Under a laparoscope, the mesh was measured from the vaginal vault to the sacral promontory to determine the desired length, and the necessary trimming was done. The distal end of the mesh was interrupted sutured and fixed to the anterior longitudinal ligament at the sacral promontory with a total of 3 non-absorbable sutures (Ethibond; Ethicon). A vaginal examination was performed with fingers to ensure the POP-Q measurement for POP-Q point C was − 8 cm to − 10 cm after suspension. The parietal peritoneum was then closed to end the surgical procedure. General patient characteristics were collected from the chart before the women were discharged, and the information was verified and input into a computer database. Both the anatomic and sexual assessments were conducted by examiners in the Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, who were blind to other study data. Anatomic results were evaluated for pelvic organ support at 6 weeks, 6 months, and 12 months after surgery, and then yearly via the standardized POP-Q technique. Surgical success for the anterior and posterior segments was defined as POP-Q stage I or lower, as recommended by the NIH Standardization Workshop [6]. Patient satisfaction was determined by a quality-of-life questionnaire. Sexual outcomes were assessed at 6 months after surgery and then yearly via the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The follow-up rate was 100%, and the most recent measurements for each patient were reported in the study. A paired t test was used to compare the means of variables with normal or approximately normal distributions (the Shapiro–Wilk test was used to determine the distribution of population), and Wilcoxon rank-sum test was used to compare pre- and postoperative total PISQ-12 scores. All analyses were done via SPSS version 16.0 (IBM, Armonk, NY, USA). For all tests, a P value of less than 0.05 was taken to be significant.
3. Results During the study period, 21 patients had modified LSC with mesh and were enrolled in the study. All participants had stage III or higher POP-Q. The age range of the study group was 32–54 years, and the mean was 41.5 years. Gravidity ranged from 2 to 5 (mean, 3.2), and parity ranged from 1 to 4 (mean, 1.9). No patient was excluded from the analysis.
171
Table 1 Pre- and postoperative POP-Q measurements.a Measurement
Preoperative, cm
Postoperative, cm
P valueb
Aa Ba C GH PB TVL Ap Bp
1.5 ± 1.9 1.1 ± 2.8 3.4 ± 1.3 5.6 ± 1.0 2.4 ± 0.5 7.7 ± 0.9 1.8 ± 3.5 0.9 ± 4.1
−2.5 ± 0.5 −2.6 ± 0.9 −8.9 ± 0.7 4.4 ± 0.7 3.9 ± 0.5 9.6 ± 1.1 −2.1 ± 0.5 −2.8 ± 0.7
b0.01 b0.01 b0.001 b0.05 b0.05 b0.01 b0.01 b0.05
a b
Values are given as mean± SD unless stated otherwise. By paired t test comparing pre- and postoperative POP-Q measurements.
The mean operating time was 95.6 minutes (range, 85–150 minutes), and the mean blood loss was 147 mL. No intraoperative complications such as injuries or hemorrhage occurred; the postoperative febrile morbidity (defined as “2 oral temperatures higher than 38 °C, taken at least 4 hours apart starting 24 hours after the operation” [7]) was 4.8% (1/21). Over the median follow-up time of 43.5 months (range, 18– 60 months), the surgical success rate was 100%. Objective assessment demonstrated that the POP-Q score for each patient improved significantly compared with the preoperative value (Table 1). Postoperatively no patient had symptomatic prolapse, and all patients had good apical anatomic support. Subjectively, approximately 90.4% of the patients thought that their operation was “very successful,” and 95.2% considered themselves “much better” than before the operation. Three months after surgery, 20 of 21 patients (95.2%) were sexually active. According to the PISQ-12 score, there was a significant improvement in total PISQ-12 score and in 5 individual PISQ-12 items (sexual excitement, sexual desire, avoidance of intercourse because of prolapse, negative emotional reactions during sexual activity, and comparison of orgasmic level between the past and the present) (Table 2). Six months after surgery, 1 patient (4.8%) developed stress urinary incontinence (SUI), and 1 patient (4.8%) experienced exposure of approximately 3 cm by 2 cm of mesh at the vaginal vault, which required transvaginal surgical excision of the exposed mesh and vaginal mucosa suturing under intravenous anesthesia. Six months after repair, gynecologic examination indicated that the mucosa of the vaginal vault was completely normal. The patient was followed for another 2 years, and recurrent prolapse did not occur. 4. Discussion Abdominal sacrocolpopexy is an operation that lifts the prolapsed vagina back up to its normal position by attachment of a synthetic mesh from the top and back of the vagina to the ligaments of the sacrum.
Table 2 Pre- and postoperative PISQ-12 results.a Item
Preoperative score
Postoperative score
Mean improvement, percentage
P valueb
Total score Sexual excitement Sexual desire Avoidance of intercourse due to prolapse Negative emotional reactions during sexual activity Comparison of orgasmic level between past and present
31.6 ± 3.2 2.1 ± 0.7 1.7 ± 0.6 1.5 ± 1.4
38.5 ± 3.9 2.5 ± 0.7 2.4 ± 0.8 3.4 ± 0.8
21.9 16.7 38.2 123.3
b0.001 b0.01 0.001 0.001
1.1 ± 1.0
3.1 ± 0.8
195.2
b0.001
1.1 ± 0.6
2.7 ± 0.6
131.8
b0.001
Abbreviation: PISQ, Prolapse/Urinary Incontinence Sexual Questionnaire. a Values are given as mean± SD unless stated otherwise. b By Wilcoxon rank-sum test comparing pre- and postoperative PISQ-12 scores.
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With a success rate of 74% to 98% [1,3], abdominal sacrocolpopexy has long been regarded as the gold standard procedure for the treatment of POP. Sacrocolpopexy involves vaginal suspension from several sites. Meshes can be attached to the vaginal vault, the mid-anterior and posterior vaginal walls, or the perineal body, and are then suspended to the sacral promontory. Attaching meshes to the vaginal vault, which might not provide enough support, leads to easy tears that can result in failure of the repair. Inserting meshes deep into the perineal body, with the anterior strip placed behind of the trigone of bladder, should also be avoided to decrease the risk of hemorrhage and detrusor instability after surgery. In addition, the effect on sexual function of attaching meshes to the perineal body remains unknown. As a result, the meshes were inserted into the superior third of the anterior and posterior vaginal walls in the present study. In 1994, Nezhat et al. [8] reported the first instance of using LSC to manage POP, in which the prolapsed vaginal vault was attached to the anterior longitudinal ligament of the sacrum over the third and fourth sacral vertebrae using mesh. Subsequently, operational difficulties prompted some surgeons to attach the vaginal vault to the anterior longitudinal ligament of the sacral promontory [9,10], leading to a satisfactory success rate similar to that for abdominal sacrocolpopexy [2]; however, this procedure requires agility with laparoscopic suturing and, thus, lengthens the operating time. Ganatra et al. [4] reviewed several studies on LSC and concluded that the mean operating time was 158 minutes, leading to a bottleneck in the development of LSC. In the present study, part of the procedure was carried out via the transvaginal route, which greatly simplified the suturing procedure with the laparoscope. The mean operating time was 95.6 minutes, which is much shorter than the reported average of 158 minutes. In addition, over the median follow-up time of 43.5 months, the rates of patient satisfaction and objective success were 90.4% and 100%, respectively. The reduced operating time, coupled with adequate clinical results, make this modified LSC approach more feasible. Historically, few studies have contrasted sexual function before and after POP operations. According to a pooled analysis [4], assessment of postoperative sexual function outcomes in 8 studies found that 7.8% (range, 0%–47%) of patients had sexual dysfunction after LSC. At present, the PISQ is the only validated sexual function questionnaire (i.e. with level B evidence, and recommended by the ICS) for women with POP. The present study used PISQ-12, which contained 12 questions selected from the long form [11]. All patients except 1 (because of mesh exposure) were postoperatively sexually active, with a dyspareunia rate of 4.8%. For the 20 patients who were sexually active after surgery, the total PISQ-12 score and 5 individual PISQ-12 items (sexual excitement, sexual satisfaction, avoidance of intercourse, negative emotional reactions, and orgasmic level) improved significantly, which is an advantage of the present approach. The main factor that affects sexual function negatively might be mesh exposure, which usually occurs in the first 3–36 months after operation [12,13]. The incidence of vaginal mesh exposure has been reported to vary from 3% to 14% among patients treated by sacrocolpopexy [13,14]. In a study of 402 patients who were followed for 12 months, Stepanian et al. [15] found that women who underwent concurrent hysterectomy during sacrocolpopexy had a mesh exposure rate of 2.3%, compared with 0.7% of women with a history of previous hysterectomy who underwent sacrocolpopexy. Because both incidences of mesh exposure were very low, however, they found no significant difference (P = 0.18) in the risk of mesh-related complications. In the present study, concurrent hysterectomy was carried out before the meshes were transvaginally attached and sutured to the vaginal vault to reduce the difficulty of the operation under the laparoscope. The mesh exposure rate of 4.8% (1/21), which is slightly high owing to the small sample volume, seems acceptable; however, more prospective, high-powered trials are needed to confirm these results.
Intraoperative complications of sacrocolpopexy that have been reported include injuries to the bladder, ureters, or bowel, and hemorrhage owing to injuries to the venous plexus of the presacral region. In general, these severe complications have a low incidence, and no intraoperative complications occurred in the present study. Postoperative complications, by contrast, include SUI, urinary tract infection, urinary retention, bowel dysfunction, and mesh exposure or extrusion. According to the pooled analysis by Ganatra [4], 17.8% (range, 2.4%–44%) of patients treated by LSC had SUI, urinary urgency, or urinary retention postoperatively, whereas postoperative bowel dysfunction such as constipation, anal pain, and fecal incontinence occurred in 9.8% (range, 0%–25%) of the patients. In the present study, 1 patient (4.8%) developed postoperative SUI. No other complications were observed, which may be due to the small sample volume. The present assessment had some limitations. First, the number of patients was small and the patients were evaluated over a short period of time. Second, owing to the sample size, it was not possible to have 2 study groups to compare the risk of mesh exposure between patients who underwent concurrent hysterectomy at the time of sacrocolpopexy and those with a history of previous hysterectomy. Third, in terms of evaluating sexual outcomes, the study design did not include a control group, which therefore prevented statistical analyses between groups because all of the patients were exposed to surgical intervention. In summary, modified LSC with mesh was found to be a simple and safe procedure for the treatment of severe POP, and it did not seem to interfere with sexual function. A prospective controlled trial with a larger patient sample and a longer follow-up period would confirm the present results. Conflict of interest The authors have no conflicts of interest. References [1] Hilger WS, Poulson M, Norton PA. Long-term results of abdominal sacrocolpopexy. Am J Obstet Gynecol 2003;189(6):1606–10. [2] Rozet F, Mandron E, Arroyo C, Andrews H, Cathelineau X, Mombet A, et al. Laparoscopic sacral colpopexy approach for genito-urinary prolapse: experience with 363 cases. Eur Urol 2005;47(2):230–6. [3] Occelli B, Narducci F, Cosson M, Ego A, Decocq J, Querleu D, et al. Abdominal colposacroplexy for the treatment of vaginal vault prolapse with or without urinary stress incontinence. Ann Chir 1999;53(5):367–77. [4] Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, et al. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol 2009;55(5):1089–103. [5] Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175(1):10–7. [6] Barber MD, Brubaker L, Nygaard I, Wheeler II TL, Schaffer J, Chen Z, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 2009;114(3):600–9. [7] Ghezzi F, Franchi M, Buttarelli M, Serati M, Raio L, Maddalena F. The use of suction drains at burch colposuspension and postoperative infectious morbidity. Arch Gynecol Obstet 2003;268(1):41–4. [8] Nezhat CH, Nezhat F, Nezhat C. Laparoscopic sacral colpopexy for vaginal vault prolapse. Obstet Gynecol 1994;84(5):885–8. [9] Cosson M, Rajabally R, Bogaert E, Querleu D, Crépin G. Laparoscopic sacrocolpopexy, hysterectomy, and burch colposuspension: feasibility and short-term complications of 77 procedures. JSLS 2002;6(2):115–9. [10] Ross JW. Techniques of laparoscopic repair of total vault eversion after hysterectomy. J Am Assoc Gynecol Laparosc 1997;4(2):173–83. [11] Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct 2003;14(3):164–8. [12] Higgs PJ, Chua HL, Smith AR. Long term review of laparoscopic sacrocolpopexy. BJOG 2005;112(8):1134–8. [13] Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol 2008;199(6):688.e1–5. [14] Visco AG, Weidner AC, Barber MD, Myers ER, Cundiff GW, Bump RC, et al. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol 2001;184(3):297–302. [15] Stepanian AA, Miklos JR, Moore RD, Mattox TF. Risk of mesh extrusion and other mesh-related complications after laparoscopic sacral colpopexy with or without concurrent laparoscopic-assisted vaginal hysterectomy: experience of 402 patients. J Minim Invasive Gynecol 2008;15(2):188–96.