Laparoscopic sacrocolpopexy posthysterectomy: intraoperative feasibility and safety in obese women compared with women of normal weight

A single-centre, retrospective cohort study was performed to evaluate the outcomes and adverse events following insertion of a lightweight mesh, Restorelle^®, in women undergoing LSC (manuscript accepted for publication in European Journal of Obstetrics and Gynecology). The study excluded sacrohysteropexy, as it was designed to evaluate a mesh specifically designed for sacrocolpopexy. Secondary analysis was performed to evaluate the efficacy and safety of LSC in obese women compared with those with a normal body mass index (BMI). All women who underwent LSC between March 2005 and January 2013 were invited to participate and provided informed consent. During this time, operating surgeons routinely offered LSC to all women presenting with vault prolapse defined as point C at stage 2, or stage 1 with a large concomitant anterior- or posterior-compartment POP, irrespective of their BMI. Contraindications to a laparoscopic procedure included previous major intra-abdominal surgery with significant intra-abdominal scarring preventing access to the sacral promontory, and respiratory or cardiovascular disease leaving women unable to tolerate a general anaesthetic. Inclusion criteria for secondary analysis were surgery for LSC, BMI at the time of surgery recorded in the case records and patient willingness and ability to provide informed consent and attend follow-up examination. Women were excluded if inclusion criteria were not met. All operations were performed in a tertiary unit by one of three subspecialist surgeons trained in laparoscopic urogynaecology.

The study was approved by the North-West Greater Manchester Central Research Ethics Committee (reference 12/NW/0277) and registered with Current Controlled Trials (ISRCTN19907894). Informed consent was obtained from all individual participants in the study.

The same technique was used for all women, regardless of BMI. LSC was performed under general anaesthesia, and all women received antibiotic prophylaxis. Women were placed in the Lloyd-Davies position and a Foley catheter inserted. Three trocars were used: one primary umbilical 10-mm cannula and two lateral (one 5 mm and one 11 mm) trocars. The sacral promontory was identified, the prevertebral parietal peritoneum dissected to expose the retroperitoneal fat and the retroperitoneal fat dissected to expose the anterior vertebral ligament. The peritoneal incision was then extended towards the rectosigmoid. The bladder was dissected from the anterior vaginal wall and the peritoneum dissected from the posterior vaginal wall. The dissection was extended in cases of a large rectocele or cystocele to facilitate extension of mesh placement. The two arms of a Y-shaped piece of mesh were sutured to the anterior and posterior walls of the vagina using polydioxanone (PDS), with a minimum of four sutures on each. The vault was positioned tension free at the level of the ischial spines and the mesh fixed to the sacral promontory using Protack staples. The peritoneum was then closed using a continuous running suture.

Demographic data on age, smoking status, parity and mode of any deliveries, preoperative comorbidities, prolapse symptoms, prior conservative management and previous prolapse or incontinence surgery was collected. Preoperative BMI was used to group women into BMI class according to the World Health Organisation (WHO) classification: normal weight = 18.5–24.9 kg/m²; overweight = 25.0–29.9 kg/m²; obese ≥30 kg/m² [9]. Complications were recorded using the International Continence Society/International Urogynaecological Association (ICS/IUGA) classification of complications related directly to the insertion of prostheses (meshes, implants, tapes) or grafts in female pelvic floor surgery [10]. Paper case notes and electronic data systems were hand-searched for information regarding operating time, duration of anaesthetic, anaesthetic complications and duration of in-patient stay.

Preoperatively, all women underwent a Pelvic Organ Prolapse Quantification (POP-Q) system examination. Postoperatively, they underwent POP-Q grading and an assessment for mesh palpability. All scores were converted to their corresponding stages using the system described by IUGA/ICS [11]. Postoperative assessment was routinely conducted by an independent health-care practitioner, who was not the operating surgeon, to limit bias. Women completed a Patient Global Impression of Improvement (PGI-I) questionnaire for urogenital prolapse to assess subjective improvement after treatment [12]. All data were collected by one researcher and cross-checked by one of two other researchers for standardisation.

The primary outcome measure of safety was evaluated using perioperative complication rates, duration of operation and anaesthetic and duration of in-patient stay. Secondary outcomes were patient-reported success rate using PGI-I, defined as very much better, much better and objective cure (defined as prolapse stage 0 or 1 on POP-Q examination). Data were analysed using two definitions of recurrence: vault POP stage ≥2, and point C above the level of the midvagina (defined as half the total vaginal length).

There were no cases of conversion to laparotomy, vascular injury, blood loss requiring blood transfusion, return to theatre, deep vein thrombosis or wound infection (Table 3). Bladder injury occurred in two normal weight and two overweight women. All were closed intraoperatively with completion of the LSC and managed with an indwelling catheter for 1 week, with no long-standing morbidity. There was one ureteric injury in the normal weight group, which was successfully repaired at the time of LSC. One serosal rectal injury occurred in the normal-weight group, was recognised and oversewn intraoperatively with completion of the LSC, with no further complications or long-standing morbidity.

There was a trend towards increased operating time in women of normal weight, although this was not statistically significant and not related to grade of lead surgeon (p = 0.978) (Fig. 2). There was no difference in duration of anaesthetic administration between groups (Fig. 3) or in duration of hospital stay (p = 0.898; median for all groups 1 day, IQR 1–2 days).

There were no cases of mesh erosion or other mesh complications.

Six-month follow-up data was available for 80 women. There was no significant difference in subjective cure rate, defined as very much or much better, on PGI-I. Rates were reported as 76.9% in the normal weight, 72% in the overweight and 65.4% in the obese group (overall p = 0.669, normal weight vs obese p = 0.556). Two women in the overweight group reported feeling very much worse: one developed chronic pelvic pain due to nerve entrapment following degenerative spinal disease, and one developed severe constipation.

There was no difference in objective cure at 6 months measured using the POP-Q for anterior, posterior and apical compartments between normal weight, overweight and obese women, (p = 0.098, 0.282 and 0.402, respectively). The apical compartment was above the level of the midvagina (defined as half the total vaginal length) in all women except for one case of recurrence. This recurrence occurred in the overweight group in woman who experienced a stage 3 vault POP, which she reported occurred suddenly 5 months postoperatively following a chest infection. She subsequently declined further investigation and was treated with a ring pessary.

This was a single-site, retrospective study which may have led to selection bias. However, this was minimised by the fact all women with vault prolapse were offered LSC during this time frame, regardless of BMI. The retrospective design of the study also meant there were some missing data points. Due to the size of the obese cohort, data for these women were combined into one group rather than being analysed separately obese, severely obese and morbidly obese women. Morbidly obese women, in particular, present a different set of surgical and anaesthetic challenges to obese and severely obese women, meaning conclusions from this study should be extrapolated to morbidly obese women with caution.

Although the three groups had similar baseline characteristics, the obese cohort was more likely to have a stage 3–4 apical POP on preoperative POP-Q. This may reflect that obese women with stage 2 vault POP were less likely to opt for surgery or an abdominal approach, or that in this cohort, they presented with a greater degree of POP than women who were overweight or of normal BMI. Preoperative POP stage 3 or 4 is a risk factor for recurrence, and this bias could have affected subjective and objective cure rates in the obese group, although our analysis would suggest this was not the case [3, 18].

This study demonstrates LSC is equally effective and with a comparable safety profile for normal weight, overweight and obese women when performed by a trained laparoscopic urogynaecologist. Data show a trend towards increased operating time in normal weight women. One possible explanation is that surgeons are more likely to undertake complex cases, such as those with dense adhesions or previous urostomy, in women of normal BMI. An alternative explanation is that surgeons may prefer teaching trainee surgeons whilst operating on women of normal BMI, which in turn may lead to longer operating times. This could also be a reflection of the small sample size.

All operations were performed in a tertiary unit by subspecialist urogynaecologists trained in laparoscopic urogynaecology. LSC can be technically challenging and requires an experienced laparoscopic surgeon to perform, particularly in overweight and obese women due to difficulty accessing the sacral promontory. This is because the sacral promontory may be more difficult to identify and dissect in overweight and obese women, increasing the risk of a major vascular injury. Another difficulty performing LSC in obese women is in maintaining adequate ventilation while generating sufficient abdominal pressure to perform the procedure. We found this is easier when working with anaesthetists with bariatric experience. Our findings may not be generalisable to smaller units that do not have the equipment or personnel for managing obese women undergoing laparoscopy.

Findings from this study are important, particularly in the context of the expanding obesity epidemic. Our data supports offering LSC to obese women with vault prolapse. It is our practice to offer both a LSC and a non-mesh alternative in the form of a vaginal sacrospinous fixation to all suitable women presenting with vault prolapse who wish to have surgical management as part of a patient-centred, nondirective approach to care.