Surgical repair of pelvic organ prolapse is one of the most frequent gynecological procedures, and its frequency is expected to increase as the population is gradually aging.1,2
According to a recent Cochrane review,3 abdominal promontofixation is the criterion standard surgical procedure for correction of the uterovaginal prolapse. This procedure is associated with a lower rate of recurrent prolapse and less dyspareunia compared with vaginal approach. Laparoscopic promontofixation compared with laparotomic approach is associated with shorter hospital stay, quicker postoperative recovery, and decreased blood loss and postoperative pain.4,5
In literature dealing with laparoscopic promontofixation, a mesh is used to suspend the central compartment to the anterior longitudinal ligament of the sacrum.6 Despite the promising results confirmed by several studies,7,8 laparoscopic promontofixation is a challenging technique because of the long learning curve required and the risks of serious complications associated with the mesh use (vaginal mesh erosion or fistula, severe dyspareunia, spondylodiscitis) that can be debilitating and require multiple surgeries to repair. These postoperative complications are more commonly reported after colposacropexy rather than in cases of uterine or cervical suspension (hysterosacropexy and cervicosacropexy, respectively).9 Krause et al10 described for the first time the technique of laparoscopic hysterosacropexy without mesh and demonstrated the efficacy and feasibility of this technique in the management of uterine prolapse in women who want to preserve the uterus. Because of the preservation of the uterus, their technique did not include restoration of pericervical fascia but only a support of posterior aspect of the cervix.10
In this study, we report our experience in the use of laparoscopic mesh-less cervicosacropexy technique and its surgical and functional outcomes in a cohort of women with uterovaginal prolapse without desire of uterine preservation.
MATERIALS AND METHODS
In this prospective, single-center cohort study, women with uterovaginal prolapse stage 2 or higher according to the Pelvic Organ Prolapse Quantitative (POP-Q) classification system11 undergoing laparoscopic mesh-less cervicosacropexy in our center were enrolled between July 2013 and March 2016. Exclusion criteria were history of neoplastic or preneoplastic gynecological diseases, including abnormal cervical cytological examination, contraindications to laparoscopy, and cases with previous total hysterectomy. Women were enrolled at the preoperative visit and widely advised on available treatment strategies before making their choice. All women provided written informed consent. The study protocol was approved by our local ethical committee (1212016/O/Sper).
The following data were collected for each patient: age, body mass index, vaginal parity, menopausal status, hormone replacement therapy use, history of previous abdominal surgery for genital prolapse, and/or urinary incontinence. Before surgery, genital prolapse was described using POP-Q classification. Patients were assessed preoperatively using gynecological examination, pelvic ultrasound, smear test, urodynamic study to evaluate subclinical stress incontinence, and, in case of abnormal uterine bleeding, diagnostic hysteroscopy with endometrial biopsy. For each patient, operating times, hospitalization length, and perioperative and postoperative complications were recorded. All patients were also evaluated before and every 6 months after surgery for prolapse-related symptoms (urinary stress incontinence, urge incontinence, voiding dysfunction, dyspareunia, and feeling of genital prolapse). To evaluate pelvic organs' function both during preoperative assessment and 12 months after surgery, patients also responded to the following validated questionnaires:
- the Female Sexual Function Index (FSFI) questionnaire to assess sexual function.12 Each domain was considered dysfunctional when the corresponding score was equal to or lower than 4.3; a cutoff value of 26.5 for the global score was used to diagnose sexual dysfunction.13
- the Bristol Female Lower Urinary Tract Symptoms (BFLUTSs) questionnaire to allow the assessment and quantification of lower urinary tract symptoms in women, including incontinence symptoms (5 items), voiding symptoms (3 items), and filling symptoms (4 items).14,15
- the Knowles-Eccersley-Scott Symptom (KESS) questionnaire to evaluate bowel functions; its total score was the sum of all scores gained on individual questions with a maximum of 39 points.16 We considered a cutoff criterion of 10 or higher as a good indicator of constipation.
During follow-up, a gynecological examination was performed by an independent researcher every 6 months to evaluate anatomical recurrence of genital prolapse (POP-Q stage ≥2), in particular of central prolapse (POP-Q score C ≥−1). Patients were asked about the sensation of bulge, personal satisfaction related to surgery (assessed as “high,” “moderate,” or “no satisfaction”), and any retreatment in case of failure (pessary or surgery).
All procedures were performed under general anesthesia with antibiotic prophylaxis. Patients were placed in the semi-lithotomic position, which allowed both vaginal and laparoscopic approaches, and a bladder catheter was placed. Before laparoscopy, other vaginal procedures were performed when necessary to repair any anterior and/or posterior prolapse. After CO2 pneumoperitoneum was created, a 12-mm trocar was placed in the umbilical site to introduce laparoscope and camera. Three 5-mm trocars were inserted in the suprapubic area. A subtotal hysterectomy was performed by conventional technique.17 The uterus was removed from the abdominal cavity via safe endobag mechanical morcellation.
Bologna mesh-less cervicosacropexy consists of suspension of the cervix up to the anterior longitudinal ligament of the sacral promontory through a continuous suture (nonabsorbable monofilament suture) plicating the right uterosacral ligament. Surgical steps are (1) identification of the course of the right ureter and of the sacral promontory; (2) incision of the peritoneum at the level of the sacral promontory and development of the presacral space (Fig. 1A); (3) after identification of common iliac vessels, the superior hypogastric plexus, and right hypogastric nerve, positioning of a first stitch on the longitudinal ligament of the sacral promontory, preserving integrity of middle sacral vessels and autonomic nerves (Fig. 1B); (4) craniocaudal plication with transfixion of the right uterosacral ligament, along its intermediate and distal (proximal to the cervix) part of right uterosacral ligament (Fig. 1C); (5) suspension of the posterior cervix at the level of insertion of the uterosacral ligaments and restoration of the pericervical fascia (Fig. 1D); (6) retrograde transfixion of the right uterosacral ligament to the sacral promontory (Fig. 1E); (7) tension-free binding of the suture to the first stitch, with approximation of the cervix to the sacrum under moderate tension to achieve adequate elevation according to the need of suspension, at least 8 to 10 cm above the level of vaginal introitus (Fig. 1F); and (8) closure of the parietal peritoneum, to avoid internal herniation.
After removal of the urinary catheter on postoperative day 2, a postvoid residual volume (normal if less than 100 mL) was evaluated.
All the procedures were performed by experienced surgeons after training in laparoscopic prolapse repair.
Analysis was performed using the Statistical Package for Social Sciences software version 20.0 (SPSS Inc, Chicago, Ill). Continuous data were expressed as mean and SD or median and range when indicated, whereas categorical variables were reported in absolute and percent values. Comparison of preoperative and postoperative questionnaire scores was performed using Student t test and Wilcoxon signed-rank test. Significance was set at P < 0.05.
Forty-six women were enrolled in the study. Preoperative data are summarized in Table 1. Mean (±SD) preoperative C point was 1.8 (±1.4) with a range of −0.5 to 4.0.
Anterior vaginal wall repair in 41 patients (89.2%), posterior vaginal wall repair in 37 (80.4%), Kelly urethropexy in 11 (24%), transvaginal tape placement in 6 (13%), paravaginal repair in 16 (34.8%), adhesiolysis in 14 (30.4%), bilateral salpingo-oophorectomy in 41 (89.2%), and bilateral salpingectomy with conservation of the ovaries in 5 (11.8%) were performed. No case of laparotomic conversion was observed.
Mean operative time was 97.4 ± 25.6 (range, 60–180) minutes, mean hospitalization length was 3.6 ± 0.9 (range, 2–6) days, and mean hemoglobin level decrease was 2.2 ± 0.8 (range, 0.4–4.2) g/dL.
On second postoperative day, 1 patient (2.2%) complained transient urinary retention that was resolved spontaneously after 2 days.
During the first month after surgery, 5 patients (10.9%) presented with “de novo” constipation (without evidence of posterior vaginal wall prolapse) and 2 patients (4.3%) with “de novo” low back pain. “De novo” low back pain resolved spontaneously after 6 months, whereas constipation ameliorated without complete resolution with the use of bulking laxative and diet.
The median follow-up was 24 (range, 12–38) months. Postoperative symptoms and POP-Q data at follow-up are illustrated in Table 2. During the follow-up period, the objective success rate for central prolapse, defined as POP-Q score C higher than −1, was 93.5% (43/46 women) and there were 3/46 (6.5%) women with central compartment failure. Furthermore, other 2 patients presented at follow-up an anterior stage 2 prolapse, determining a global objective success rate of 89.1% (41/46 women). All objective recurrences were observed during the first 6 months of follow-up. Only women with recurrent central prolapse (3/46, 6.5%) complained symptom of bulge, whereas other patients with anterior prolapse recurrence were asymptomatic. One patient with symptomatic stage 4 central prolapse was submitted to a second laparoscopic surgery with the finding of rupture of the suture at the level of cervical stump. For this patient, the same technique of mesh-less cervicosacropexy was performed and no recurrence was observed during follow-up of 12 months. The other 4 patients with objective failure were treated conservatively because they were pauci or asymptomatic.
At 12 months of follow-up
- overall FSFI scores improved significantly (P = 0.002) after surgery (Figs. 2A, B). Before surgery, 16 patients (34.8%) had a sexual life–related distress, defined as FSFI score 26.5 or lower; after surgery, only 1 patient had persistent sexual dysfunction.
- median preoperative total KESS score was 8.8 ± 4.7 (mean ± SD; range, 0–17), whereas after surgery it was 6.3 ± 3.2 (mean ± SD; range, 2–11) (Fig. 2C), with a significant improvement (P = 0.007) of the scores after surgery.
- overall BFLUTS scores significantly decreased after surgery (BFLUTS–filling symptoms, P = 0.003; BFLUTS–voiding symptoms, P = 0.004; BFLUTS-total, P = 0.005), except for BFLUTS–incontinence symptoms (P = 0.08) (Figs. 2D, E).
Thirty-nine women (84.8%) reported having had a very high satisfaction, whereas 6 (13%) had a moderate satisfaction. Only 1 patient expressed a negative feeling about the operation.
Our data demonstrated that laparoscopic mesh-less cervicosacropexy for uterovaginal prolapse seems to be an effective surgical technique for 2 years of midterm follow-up. This mesh-less technique had a more than satisfying success rate with only 3 recurrences of central compartment prolapse.
Despite the good results, laparoscopic promontofixation with mesh use is associated with important complications strictly related to the use of the mesh. Vaginal mesh exposure (VME) was the most common complication related to mesh use.18 The consequences of erosion varied from negligible to severe, and VME often required more than 1 reoperation.19,20 The probability of mesh erosion in women undergoing cervicosacropexy with mesh use was approximately 2.5%.21 In our series, no cases of vaginal erosions were observed during follow-up. Claerhout et al22 after a mean follow-up of 12.5 months after laparoscopic colposacropexy with mesh reported a “de-novo” dyspareunia in 19% of the patients. In our study, no women complained “de-novo” dyspareunia during follow-up. The absence of “de-novo” dyspareunia in mesh-less promontofixation may be explained by several factors: (1) supracervical hysterectomy does not impact negatively on the length of the vagina and allows the preservation of uterosacral and cardinal ligaments23; (2) mesh-less procedure is less associated with foreign material reactions and vaginal erosions; and (3) low risk of autonomic pathways' injury due to a minimal dissection of the retroperitoneal spaces rather than to the classical steps of mesh procedure.10 In our series, “de-novo” constipation was reported only in some patients (10.9%) during follow-up, whereas Maher et al24 recorded de-novo bowel symptoms in 10% to 50% of women after promontofixation using mesh. Dissection of the medial sacral promontory could be associated with an increased risk of irritation of the sympathetic fibers of the superior hypogastric, resulting in obstructed defecation syndrome.25 According to Krause et al,10 we standardized the retroperitoneal dissection at the level of the sacral promontory with a lateral approach, minimizing the risk of injury of neural pathways. We also had only 2 patients with “de-novo” low back pain, whereas Sergent et al26 reported in a series of 124 patients with mesh promontofixation 15 cases (12%) who accused “de-novo” postoperative lumbar pain.26 Lumbosacral spondylodiscitis is a serious but rare complication. Deffieux et al27 reported spondylodiscitis in 0.2% of laparoscopic sacralcolpopexy. Infection near the operated areas, VME or vaginal fistula, and the location where the mesh is sutured to the promontory (disc or vertebra) are the main risks factors for the development of spondylodiscitis.28 No case of spondylodiscitis was reported in our series.
Concerning functional outcomes of our technique, the validated questionnaire scores showed an improvement of bladder, bowel, and sexual functions 12 months after surgery. Costantini et al29 demonstrated that pelvic organ prolapse plays a role in female sexual dysfunction and reported a significant improvement in the domain of sexual desire, arousal, and orgasm after surgery. In our study, overall FSFI scores improved significantly after laparoscopic mesh-less cervicosacropexy.
Some limitations of the study should be acknowledged: the results cannot be generalized because of the small sample size, the single institution and surgeon experience, the absence of a control group, and a short follow-up. Long-term follow-up and randomized multicenter study are needed to draw definitive conclusions. Laparoscopic mesh-less cervicosacropexy represents an effective, safe, and feasible option for the surgical treatment of uterovaginal prolapse in sexually active women, avoiding postoperative complications due to the use of mesh.
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