Objective
Our first objective was to compare peri- and postoperative adverse events between robotic-assisted laparoscopic sacrocolpopexy (RSC) and conventional laparoscopic sacrocolpopexy (LSC) in a cohort of women who underwent these procedures at a tertiary care center. Our second objective was to explore whether hysterectomy and rectopexy at the time of sacrocolpopexy were associated with these adverse events.
Study Design
This was a retrospective cohort study of women who underwent either RSC or LSC with or without concomitant hysterectomy and/or rectopexy from 2006-2012. Once patients were identified as either having undergone RSC or LSC, the electronic medical record was queried for demographic, peri-, and postoperative data.
Results
Four hundred six women met study inclusion criteria. Mean age and body mass index of all the women were 58 ± 10 years and 27.9 ± 4.9 kg/m 2 . The women who underwent RSC were older (60 ± 9 vs 57 ± 10 years, respectively; P = .009) and more likely to be postmenopausal (90.9% vs 79.1%, respectively; P = .05). RSC cases were associated with a higher intraoperative bladder injury rate (3.3% vs 0.4%, respectively; P = .04), a higher rate of estimated blood loss of ≥500 mL (2.5% vs 0, respectively; P = .01), and reoperation rate for pelvic organ prolapse (4.9% vs 1.1%, respectively; P = .02) compared with LSC. Concomitant rectopexy was associated with a higher risk of transfusion (2.8% vs 0.3%, respectively; P = .04), pelvic/abdominal abscess formation (11.1% vs 0.8%, respectively; P < .001), and osteomyelitis (5.6% vs 0, respectively; P < .001). The mesh erosion rate for all the women was 2.7% and was not statistically different between LSC and RSC and for patients who underwent concomitant hysterectomy and those who did not.
Conclusion
Peri- and postoperative outcomes after RSC and LSC are favorable, with few adverse outcomes. RSC is associated with a higher rate of bladder injury, estimated blood loss ≥500 mL, and reoperation for recurrent pelvic organ prolapse; otherwise, the rate of adverse events is similar between the 2 modalities. Concomitant rectopexy is associated with a higher rate of postoperative abscess and osteomyelitis complications.
Uterovaginal prolapse and posthysterectomy vaginal apex prolapse are highly prevalent conditions in women that are associated with significant morbidity and a negative impact on quality of life. Surgical options to treat symptomatic pelvic organ prolapse (POP) include vaginal and abdominal approaches. Abdominal sacrocolpopexy, an operation that places mesh on the anterior and posterior vagina to suspend it to the sacrum, is considered the gold standard for vaginal apex prolapse repair and has demonstrated superior anatomic outcomes compared with vaginal suspension procedures. However, abdominal sacrocolpopexy is associated with higher morbidity and longer time to return to activities of daily living when compared with vaginal approaches.
Robotic-assisted laparoscopic sacrocolpopexy (RSC) and conventional laparoscopic sacrocolpopexy (LSC) have become alternatives to the open abdominal approach as these procedures aim at bridging the gap between the advantages of vaginal surgery, namely decreased morbidity and faster patient recovery, with the surgical success rates of abdominal sacrocolpopexy. Additionally, minimally invasive abdominal sacrocolpopexy may be beneficial for young, sexually active women with symptomatic POP, as the procedure restores normal pelvic anatomy and maintains vaginal length.
Recently, there has been a focus on comparing short- and long-term outcomes of minimally invasive approaches to sacrocolpopexy. Most of these studies have looked at outcomes in cohorts of patients after RSC and have demonstrated that the robotic approach appears safe and effective with limited risk of complications and good long-term efficacy. Data on efficacy and short-term outcomes after LSC remain scarce, with the exception of several uncontrolled case series and retrospective cohort studies and 2 randomized trials, one of which compared RSC and LSC procedures and the other compared abdominal sacrocolpopexy with LSC. Although efficacy outcomes data do exist, there are currently no large studies that compare peri- and postoperative adverse events of sacrocolpopexy performed both robotically and with conventional laparoscopy. Therefore, the primary objective of this study was to compare peri- and postoperative adverse events between RSC and LSC in a large cohort of women who underwent these procedures at a tertiary care center. Secondary aims were to explore whether hysterectomy and rectopexy at the time of sacrocolpopexy were associated specifically with these adverse events.
Materials and Methods
This study evaluated a retrospective cohort of women who underwent either RSC or LSC with or without concomitant hysterectomy and/or rectopexy at a tertiary care urogynecology center from 2006-2012. After institutional review board approval was obtained for this study, women were identified by their assigned postoperative Current Procedural Terminology codes for laparoscopic colpopexy (57425) and abdominal colpopexy (57280) for the 4 surgeons who perform minimally invasive abdominal sacrocolpopexy at our institution. This captured both RSC and LSC procedures and those procedures that had been converted to open abdominal cases. Women were excluded if they had undergone either open abdominal or laparoscopic uterosacral colpopexy or laparoscopic hysteropexy and if the open abdominal sacrocolpopexy was planned and not a conversion from the minimally invasive approach. Women from our previously published randomized controlled trial, in which women were enrolled from 2007-2009, were included in this cohort of women because we aimed to capture all women who underwent minimally invasive sacrocolpopexy from 2006-2012. Once patients were identified as either having undergone RSC or LSC at our institution, the health system-wide electronic medical record was queried for demographic, perioperative, and postoperative data. Adverse events were considered related to the surgical case if they occurred intraoperatively, in the immediate postoperative period (30 days), or up to 12 months after the index surgery for certain outcomes. Adverse events were analyzed not only independently but also as a composite rate, which was defined as a grade 3 or higher complication by the Clavien-Dindo Grading System for surgical complications. A grade 3 complication was defined as a complication that required surgical, endoscopic, or radiologic imaging/intervention (with or without anesthesia). A grade 4 complication was one that was considered life-threatening. Long-term outcomes such as recurrent POP and recurrent and de novo stress urinary incontinence (SUI) were included, regardless of time of presentation.
Four of our providers performed minimally invasive abdominal sacrocolpopexy at some point during the 2006-2012 study period. One provider had been full-time faculty many years before the start of the study period. The other 3 surgeons joined the practice out of fellowship from 2006-2011. All surgeons had performed >50 RSC and LSC cases either in fellowship or in practice before the start of this study. Our providers perform RSC and LSC using 2 pieces of light-weight polypropylene mesh. All women are positioned in low lithotomy position using Allen stirrups so that there is access to the vagina during the operation. An end-to-end anastomosis (EEA) sizer is placed in the vagina for manipulation of the apex and in the rectum for delineation of the rectovaginal septum. A Foley catheter is placed in the bladder for continuous drainage throughout the operation. After intraperitoneal access is gained and laparoscopic or robotic ports are placed and the robot is docked to the patient, the sacral promontory is identified, and the presacral space is entered and dissected until the anterior longitudinal ligament is cleared over S1-2, which serves as the attachment point for the graft. Dissection caudally through the peritoneum and subperitoneal fat is carried down to the level of the posterior cul-de-sac. The vagina is elevated cephalad with the EEA sizer; the peritoneum overlying the anterior vaginal apex is incised transversely, and the bladder is dissected off of the anterior vagina with sharp dissection, creating at least a 4-cm area for mesh fixation. Similarly, the peritoneum overlying the posterior vagina is incised, and dissection is performed overlying the vagina and extending into the posterior cul-de-sac, creating at least a 4- to 5-cm area for mesh attachment. Once dissection is complete, the mesh is fashioned into 2 arms that are approximately 4 × 15 cm in size. The graft is attached to the posterior vaginal wall with 4-6 permanent sutures or delayed-absorbable no. 0 or 2-0 sutures in an interrupted fashion, approximately 2 cm apart from each other. Sutures are placed through the fibromuscular tissue of the vagina, but not through the underlying epithelium. The graft extends approximately halfway down the posterior vaginal wall. The second arm of the graft is then attached to the anterior vaginal wall in a similar fashion. Delayed absorbable sutures are used for the most distal stitches close to the bladder to decrease the risk of permanent suture erosion into the bladder. The vagina is then elevated with the EEA sizer toward the sacrum, and appropriate suspension without tension is determined by visualization and with a vaginal examination before attachment of the graft to the sacrum. The graft is trimmed to the appropriate length and then sutured to the anterior longitudinal ligament at the level of S1-2 with 2-3 permanent no. 0 or 2-0 monofilament sutures. The peritoneum is then closed over the exposed graft with absorbable sutures. A cystoscopy in performed to ensure no bladder or ureteral injury.
Patients were included if they underwent concomitant POP and/or SUI procedures at the time of sacrocolpopexy, which included hysterectomy (vaginal or laparoscopic), cystocele repair, rectocele repair, and midurethral sling placement. At our institution, we favor supracervical hysterectomy at the time of sacrocolpopexy to reduce the risk of mesh erosion. Total hysterectomy is performed if there is an indication for it, as in the case of abnormal cervical disease or if the patient specifically requests it after reviewing the risks and benefits. Concomitant rectopexy was also performed (in patients with concurrent rectal prolapse) by a colorectal surgeon in some cases. Operating room (OR) times (defined as the time at which the patient enters the room to the time the patient exits the room) and case times (incision to close) were also recorded.
Descriptive statistics were reported for all groups as subsample/total sample (%) with 95% confidence intervals (CIs) for categorical variables and as mean ± SD and median (range) for all continuous variables. For the primary analysis, the LSC group was compared with the RSC group with the exclusion of those patients who received concomitant rectopexy. A secondary analysis was performed to evaluate the outcomes of those who received LSC or RSC with rectopexy with those who did not receive a rectopexy and those women who underwent LSC or RSC with hysterectomy with those who did not. Comparisons of outcomes were performed with the Student t test for parametric continuous outcomes, the Mann Whitney U test for nonparametric outcomes, and a chi-square test for all categorical outcomes. Associations between outcomes were measured by Pearson’s correlation. All tests were 2-sided and were considered significant at the .05 level. Multivariate analysis was not performed because the small number of adverse events that were noted resulted in unstable models. We used JMP software (version 10.0; SAS Institute Inc, Cary, NC) for all statistical analyses.
Results
Five hundred eighty-two women were identified; 406 women met inclusion criteria and had experienced either minimally invasive abdominal sacrocolpopexy or conversion to open abdominal sacrocolpopexy from the minimally invasive approach from 2006-2012. Mean age and body mass index of all women were 58 ± 10 years and 27.9 ± 4.9 kg/m 2 , respectively. Two hundred sixty-one women underwent LSC; 145 women underwent RSC. Four surgeons performed these cases. One surgeon was responsible for 60.8% of the cases (143/261 LSC; 104/145 RSC), and the remaining 3 surgeons were responsible for 24.1% (77/261 LSC; 21/145 RSC), 9.4% (27/261 LSC; 11/145 RSC), and 5.4% (14/261 LSC; 8/145 RSC) of the cases. Overall, 83.5% of women underwent concomitant POP or SUI procedures: 25.6% hysterectomy (104/406), 7.1% anterior repair (29/406), 43.1% posterior repair (175/406), and 65% midurethral sling placement (264/406).
LSC vs RSC
Table 1 displays demographic data for the RSC and LSC groups without concomitant rectopexy. RSC patients were older (60 ± 9 vs 57 ± 10 years; P = .009) and more likely to be postmenopausal (90.9% vs 79.1%; P = .05) compared with the LSC group. Concomitant hysterectomy and rectocele repair were more common with LSC compared with the RSC cases: 28.7% vs 20% ( P = .05) and 48.7% vs 33.1% ( P = .002), respectively.
| Variable | All women (n = 370) | LSC (n = 249) | RSC (n = 121) | P value |
|---|---|---|---|---|
| Mean age, y ± standard deviation | 58.2 ± 9.8 | 57.3 ± 10.3 | 60.1 ± 8.5 | .009 a |
| Mean body mass index, kg/m 2 ± standard deviation | 27.7 ± 5.0 | 27.9 ± 5.0 | 27.1 ± 4.7 | .13 |
| Median vaginal parity, n (range) | 2 (0–7) | 2 (0–7) | 2 (0–5) | .77 |
| Median preoperative prolapse stage, n (range) | 3 (2–4) | 3 (2–4) | 3 (2–4) | .25 |
| Current tobacco use, % | 7.6 | 6.8 | 9.0 | .19 |
| Menopausal, % | 83.0 | 79.1 | 90.9 | .05 a |
| Previous pelvic organ prolapse surgery, % | 36.8 | 34.9 | 40.4 | .30 |
OR times for LSC and RSC were 300 ± 64 minutes vs 346 ± 60 minutes ( P < .001), respectively. The case times were 235 ± 60 minutes vs 275 ± 56 minutes ( P < .001). These times were significantly longer for RSC compared with LSC. Peri- and postoperative outcomes were compared with operative times, and there were no statistical associations between operating time and ileus, neurologic injury, pulmonary and cardiac complications, and deep vein thrombosis/pulmonary embolus. Overall, 2.5% of RSC cases (3/121) were converted to LSC for technical problems that were related to the robot. The overall conversion rate to an open abdominal procedure for both groups was 1.9% (95% CI, 0.9–3.9); 7 of 370 cases underwent conversion for the following indications: suboptimal visualization (n = 1), presacral bleeding (n = 1), adhesive disease (n = 1), intraoperative finding of a right common iliac artery aneurysm (n = 1), enterotomy (n = 2), and pulmonary compromise (n = 1). Mean length of hospital stay was 1.4 ± 0.7 and 1.5 ± 1.0 days for RSC and LSC cases, respectively, and this finding was not statistically significant ( P = .71).
Peri- and postoperative outcomes for patients who underwent either RSC or LSC without concomitant rectopexy are displayed in Table 2 . Overall, bladder and bowel injury rates were 1.2% (95% CI, 0.5–2.9) and 1.6% (95% CI, 0.7–3.5), respectively. The vascular injury rate was 0.7% (95% CI, 0.3–2.1) and involved bleeding from the right hypogastric vessel or the presacral space and was managed with either application of manual pressure with a sponge or vascular clips. The wound infection rate was 3.7% (95% CI, 2.3–6.0) and included only women with cellulitis of the port incisions, all of which were treated successfully with oral antibiotic therapy. The pelvic abscess rate was 0.8% (95% CI, 0.3–2.4), and these women were treated with percutaneous drainage and/or intravenous antibiotic therapy followed by an outpatient oral regimen. None of the women required reoperation for treatment of abscess. Postoperative ileus and bowel obstruction rates were 0.5% (95% CI, 0.1–1.9) and 0.8% (95% CI, 0.3–2.4), respectively, for all women who underwent sacrocolpopexy without combined rectopexy. The postoperative neurologic injury rate was 3.5% (95% CI, 2.1–5.9) and included 10 women with either iliohypogastric or ilioinguinal nerve entrapment (n = 7), who were treated with either expectant management or trigger point injection; 1 incident of pudendal neuralgia treated with neurotropic oral medications, 1 lumbosacral radiculopathy managed with physical therapy, and 1 genitofemoral neuropathy treated with trigger point injection and oral medications. Most neurologic injuries were sensory in nature, and all injuries resolved over time.
| Variable | All women (n = 370) | LSC (n = 249) | RSC (n = 121) | Odds ratio (95% confidence interval) a | P value |
|---|---|---|---|---|---|
| Conversion to open abdominal | 1.9 (0.9–3.9) | 2.0 (0.9–4.6) | 1.7 (0.5–5.8) | 0.5 (0.1–1.5) | .81 |
| Bladder injury | 1.2 (0.5–2.9) | 0.4 (0.07–2.2) | 3.3 (1.3–8.2) | 0.1 (0.02–0.93) | .04 b |
| Ureteral injury | 0 | 0 | 0 | — | — |
| Bowel injury | 1.6 (0.7–3.5) | 1.2 (0.4–3.5) | 2.5 (0.8–7.0) | 0.55 (0.1–2.8) | .36 |
| Vascular injury | 0.7 (0.3–2.1) | 0.8 (0.2–2.9) | 0.8 (0.1–4.5) | 1.1 (0.1–12.4) | .98 |
| Estimated blood loss ≥500 mL | 1.0 (0.4–2.5) | 0 | 2.5 (0.8–7.0) | 0.2 (0.02–0.81) | .01 b |
| Wound infection | 3.7 (2.3–6.0) | 2.8 (1.4–5.7) | 4.1 (1.7–9.3) | 0.8 (0.3–2.4) | .50 |
| Hematoma | 0.7 (0.3–2.1) | 1.2 (0.4–3.5) | 0 | — | .23 |
| Transfusion | 0.5 (0.1–1.8) | 0.4 (0.07–2.2) | 0 | 0.6 (0.03–8.9) | .49 |
| Pelvic abscess | 0.8 (0.3–2.4) | 0.8 (0.2–2.9) | 0.8 (0.1–4.5) | 1.4 (0.3–7.3) | .98 |
| Osteomyelitis | 0 | 0 | 0 | — | — |
| Deep vein thrombosis/pulmonary embolus | 0.5 (0.1–1.8) | 0.8 (0.2–2.9) | 0 | — | .32 |
| Ileus | 0.5 (0.1–1.9) | 0.8 (0.2–2.9) | 0 | — | .32 |
| Bowel obstruction | 0.8 (0.3–2.4) | 0.4 (0.07–2.2) | 1.7 (0.5–5.8) | 0.6 (0.08–4.0) | .21 |
| Neurologic injury | 3.5 (2.1–5.9) | 3.6 (1.9–6.7) | 3.3 (1.3–8.2) | 1.3 (0.4–4.2) | .88 |
| Pulmonary | 1.6 (0.7–3.5) | 1.6 (0.6–4.1) | 1.7 (0.5–5.8) | 0.7 (0.2–3.3) | .97 |
| Cardiac | 0.8 (0.3–2.4) | 0.8 (0.2–2.9) | 0.8 (0.1–4.5) | 0.8 (0.1–5.0) | .98 |
| Mesh erosion | 2.7 (1.5–4.9) | 2.4 (1.1–5.2) | 3.3 (1.3–8.2) | 0.3 (0.06–1.8) | .62 |
| Clavien-Dindo Grading System grade 3 c | 26.3 (22.0–31.0) | 26.4 (21.3–32.3) | 26.1 (19.0–34.6) | 1.0 (0.6–1.5) | .81 |
b Statistically significant difference at α = .05
c Requires surgical, endoscopic, or radiologic imaging/intervention (with or without anesthesia).
RSC cases were associated with a higher intraoperative bladder injury rate (3.3% [95% CI, 1.3–8.2] vs 0.4% [95% CI, 0.07–2.2]; P = .04). Each bladder injury occurred at the time of dissection and was repaired with a double-layer closure followed by retrograde fill of the bladder to ensure adequate closure; there was no need for ureteral instrumentation or reimplantation for any of these injuries. RSC was also associated with a higher rate of estimated blood loss (EBL) of ≥500 mL (2.5% [95% CI, 0.8–7.0] vs 0; P = .01). Otherwise, there were no statistical differences in peri- and postoperative outcomes between the 2 groups.
Concomitant hysterectomy
One hundred four of 406 women (25.6%) underwent concomitant hysterectomy (79.8% supracervical, 20.2% total). The rate of hysterectomy was higher in the LSC group compared with the RSC group (28.7% [95% CI, 23.6–34.5] vs 20% [95% CI, 14.3–27.2], respectively; P = .04), and supracervical hysterectomy was more likely in RSC patients than total hysterectomy when compared with LSC patients (96.6% vs 73.3%, respectively; P = .006). When total hysterectomy was performed (20.2% of all cases), vaginal hysterectomy was performed in 95.2% of cases; the remaining 4.8% were performed laparoscopically. Concomitant hysterectomy was associated with longer OR time and only slightly longer case time compared with sacrocolpopexy without hysterectomy (mean increase, 61 and 10 minutes respectively). The operative and case times in patients who underwent concomitant hysterectomy remained longer for RSC compared with LSC (361 ± 68 vs 308 ± 66 minutes [ P < .001] and 299 ± 62 vs 240 ± 60 minutes [ P < .001]). Otherwise, there were no differences noted in peri-and postoperative outcomes or adverse events in those women who underwent hysterectomy vs those who did not (data not shown).
Combined sacrocolpopexy and rectopexy
Demographic data for patients who underwent sacrocolpopexy with concomitant rectopexy are displayed in Table 3 . Women who underwent rectopexy had less severe POP preoperatively and were less likely to be menopausal. Of the 36 women who underwent concomitant rectopexy, 12 procedures were performed with LSC, and 24 procedures were performed with RSC. There were no differences between the women in these 2 groups. Table 4 shows peri- and postoperative outcomes for patients who underwent either RSC or LSC with or without concomitant rectopexy. Concomitant rectopexy was associated with a higher risk of transfusion (2.8% [95% CI, 0.5–14.2] vs 0.3% [95% CI, 0.05–1.5]; P = .04), cardiac-related complications (5.6% [95% CI, 1.5–18.1] vs 0.8% [95% CI, 0.3–2.4]; P = .01), and pelvic/abdominal abscess formation (11.1% [95% CI, 4.4–25.3] vs 0.8% [95% CI, 0.3–2.4]; P < .001). Rectopexy was also associated with a higher risk of osteomyelitis (5.6% [95% CI, 1.5–18.1] vs 0; P < .001). Osteomyelitis (n = 2) in this group occurred equally in RSC and LSC cases; bowel resection was performed in 8.6% of rectopexy cases and was not associated with infectious perioperative outcomes (data not shown).
| Variable | No rectopexy (n = 370) | All rectopexy (n = 36) | P value |
|---|---|---|---|
| Mean age, y ± standard deviation | 58.2 ± 9.8 | 58.1 ± 12.7 | .96 |
| Mean body mass index, kg/m 2 ± standard deviation | 27.7 ± 4.9 | 26.1 ± 4.9 | .08 |
| Median vaginal parity, n (range) | 2 (0–7) | 2 (0–6) | .6 |
| Median preoperative prolapse stage, n (range) | 3 (2–4) | 2 (1–3) | < .001 a |
| Current tobacco use, % | 7.6 | 8.3 | .30 |
| Menopausal, % | 83.0 | 69.4 | .04 a |
| Previous pelvic organ prolapse surgery, % | 36.8 | 41.7 | .56 |
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