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Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.

ABSTRACT: Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment. Evidence comparing outcomes and costs is lacking. We compared costs and clinically relevant outcomes in women randomized to laparoscopic sacrocolpopexy compared with robotic sacrocolpopexy.Participants with symptomatic stage POP II or greater, including significant apical support loss, were randomized to either laparoscopic or robotic sacrocolpopexy. We compared surgical costs (including costs for robot, initial hospitalization) and rehospitalization within 6 weeks. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events.We randomized 78 women (mean age 59 years): laparoscopic (n=38) and robotic (n=40). The robotic sacrocolpopexy group had higher initial hospital costs ($19,616 compared with $11,573, P<.001) and over 6 weeks, hospital costs remained higher for robotic sacrocolpopexy ($20,898 compared with $12,170, P<.001). When we excluded costs of robot purchase and maintenance, we did not detect a statistical difference in initial day of surgery costs of robotic compared with laparoscopic ($12,586 compared with $11,573; P=.160) or hospital costs over 6 weeks ($13,867 compared with $12,170; P=.060). The robotic group had longer operating room times (202.8 minutes compared with 178.4 minutes, P=.030) and higher pain scores 1 week after surgery (3.5±2.1 compared with 2.6±2.2; P=.044). There were no group differences in symptom bother by Pelvic Floor Distress Inventory, POP stage, or rate of adverse events.Costs of robotic sacrocolpopexy are higher than laparoscopic, whereas short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs.Clinicaltrials.gov, www.clinicaltrials.gov, NCT01124916.I.

SUBMITTER: Anger JT

PROVIDER: S-EPMC4266590 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.

Anger Jennifer T JT Mueller Elizabeth R ER Tarnay Christopher C Smith Bridget B Stroupe Kevin K Rosenman Amy A Brubaker Linda L Bresee Catherine C Kenton Kimberly K

Obstetrics and gynecology 20140101 1

<h4>Objective</h4>Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment. Evidence comparing outcomes and costs is lacking. We compared costs and clinically relevant outcomes in women randomized to laparoscopic sacrocolpopexy compared with robotic sacrocolpopexy.<h4>Methods</h4>Participants with symptomatic stage POP II or greater, including significant apical support loss, were randomized to either laparoscopic or robotic sacrocolpopexy. We compared su ...[more]

PMID: 24463657

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Project description:Sacrocolpopexy has been dubbed the “gold standard” repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for ≥ 12 months with surgical success at ≥ 12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004).

Project description:Sacrocolpopexy has been dubbed the âgold standardâ repair for apical pelvic organ prolapse (POP). This study sought to determine a genetic cause for sacrocolpopexy failure by comparing genotypes from 10 women who suffered from early POP reoccurance after sacrocolpopexy surgery, versus 40 randomly selected women with long term success after the same procedure. We objectively defined early overt failure after robotic-assisted laparoscopic sacrocolpopexy as having a pelvic organ prolapse quantification system examination (POP-Q) of stage III or IV occurring in more than one compartment within six months after surgery. All medical records identified during this process were then reviewed by a panel of urogynecology attendings and fellows to select patients who were truly clinical outliers. By this method we identified 10 patients (cases) who experienced early overt surgical failure. We also randomly selected 40 controls from our research database which includes greater than 500 patients who underwent robotic-assisted laparoscopic sacrocolpopexy during the same time period and had been objectively and subjectively assessed for â¥ 12 months with surgical success at â¥ 12 months that did not undergo prolapse re-operation or re-treatment. Demographics and peri-operative details were compared between cases and controls. Exclusion criteria for controls included use of other graft material besides polypropylene mesh, prior surgery for prolapse involving graft material, and conversion to laparotomy. DNA from the 10 cases and 40 controls was isolated from buccal swabs and genotyped on a single nucleotide polymorphism (SNP) array that contains 250,000 markers (NspI 250K SNP array, Affymetrix, Santa Clara, CA). All women in this study identified as Caucasian. All subjects provided written informed consent to study participation and data release. This was a case-control study approved by the Institutional Review Board at the Atlantic Health System in Morristown New Jersey (R11-10-004). This case-control study compared single genotypes of 10 cases to 40 controls. All subjects were identified as Caucasian. Cases were women who experienced early overt POP recurrence after robotic sacrocolpopexy, and controls were randomly selected women with long term success after the same procedure.

Project description:Pelvic organ prolapse (POP) is a common health problem. The lifetime risk of undergoing surgery for prolapse is 11%. POP significantly affects the effects on quality of life and activities of daily living. Laparoscopic sacrocolpopexy (LSC) has been viewed as the gold standard treatment for women with POP who desire reconstructive surgery. However, LSC is associated with technical difficulties, resulting in a long learning curve and operative time. Recently, our team introduced a new laparoscopic technique of inguinal ligament suspension (LILS) and had confirmed its safety and efficacy in treating vaginal vault prolapse. As a new surgical technique for POP, a prospective randomized controlled trial comparing the LILS with the standard technique of LSC is necessary. Therefore, we will conduct a trial.The trial is a randomized controlled trial. It compares LILS with LSC in women with stage 2 or higher uterine prolapse. The primary outcomes of this study are perioperative parameters, including surgical time, blood loss, intraoperative complications, and hospital stay as well as surgical anatomical results using the pelvic organ prolapse questionnaire (POP-Q) classification at 6 weeks, 6 months, 12 months, and annually till 5 years after surgery. Secondary outcomes are subjective improvement in urogenital symptoms and quality of life, postoperative complications, postoperative recovery, sexual functioning, and cost-effectiveness at each follow-up point. Validated questionnaires will be used and the data will be analyzed according to the intention-to-treat principle. Based on an objective success rate of 90%, a noninferiority margin of 15%, and a dropout of 20%, 107 patients are needed in each arm to prove the hypothesis with a 95% confidence interval.The trial is a randomized controlled, multicenter, noninferiority trial that will provide evidence whether the efficacy and safety of LILS is noninferior to LSC in women with symptomatic stage 2 or higher uterine prolapse.China Trial Register (CTR): ChiCTR-INR-15007408 . Registered on 9 November 2015.

Project description:ObjectiveTo determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.DesignPragmatic, blinded randomized controlled trial.SettingMultidisciplinary hernia clinics in Houston, USA.Participants124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.InterventionsRobotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).Main outcome measuresThe primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat.ResultsPatients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair.ConclusionThis study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs.Trial registrationClinicaltrials.gov NCT03490266.

Project description:OBJECTIVE:To evaluate 1- and 2-year urinary continence rates after Burch retropubic urethropexy compared with a retropubic midurethral sling for women with urinary incontinence undergoing sacrocolpopexy. METHODS:We conducted a planned secondary analysis of a multicenter, randomized, single-blind trial comparing Burch with a sling that enrolled participants from June 2009 to August 2013. Objective outcome measures of continence were assessed at 1- and 2-year follow-up through office visits and validated questionnaires. Overall continence was defined as a negative stress test, no retreatment for stress incontinence, and no self-reported urinary incontinence (International Consultation on Incontinence Questionnaire, Short Form, score, 0). Stress-specific continence was defined as fulfillment of the first two criteria and no self-reported stress-related incontinence. Primary outcomes were assessed with intention-to-treat and within-protocol analyses. Comparisons between groups were evaluated using ? or Fisher exact test. RESULTS:The two groups were similar in all measured baseline features. Outcome assessments at 2 years were available for 48 of 57 patients (84%) in the sling group and 45 of 56 patients (80%) in the Burch group. With intention-to-treat analysis, the sling group had significantly higher rates of overall continence than the Burch group (49% [28/57] vs 29% [16/56]; 95% CI for absolute risk difference 3.0-38.1; P=.03) at 1- but not 2-year follow-up (47% [27/57] vs 32% [18/56]; 95% CI for absolute risk difference -2.6 to 33.1; P=.10). The sling group had significantly higher rates of stress-specific continence than the Burch group at 1-year (70% [40/57] vs 46% [26/56]; 95% CI for absolute risk difference 6.1-41.4; P=.01) and 2-year (70% [40/57] vs 45% [25/56]; 95% CI for absolute risk difference 7.9-43.2; P=.006) follow-up. No difference was detected in prolapse recurrence, voiding dysfunction, antimuscarinic medication use, urgency incontinence, or patient satisfaction. CONCLUSION:Among women with baseline urinary incontinence undergoing sacrocolpopexy, the retropubic midurethral sling resulted in higher stress-specific continence rates than Burch retropubic urethropexy at 1- and 2-year follow-up.

Project description:BackgroundSacrocolpopexy is the gold standard procedure for treating pelvic organ prolapse (POP) patients with apical defects. Different surgical approaches have emerged and been utilized successively, including traditional laparoscopy, single-hole laparoscopy, robotic laparoscopy, vaginal-assisted laparoscopy, and transvaginal approaches. Robotic sacrocolpopexy (RSC) has attracted increasing attention as an emerging surgical technique and has unique advantages, such as a "simulated wrist" mechanical arm and high-definition three-dimensional (3D) visual field, which has gradually begun to be utilized in the clinical setting.MethodsWe followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting checklist, and a systematic literature search was conducted on six databases from their inception to 1st March 2020. We evaluated patients with POP who underwent RSC or laparoscopic sacrocolpopexy (LSC), outcomes (including perioperative outcomes: blood loss, operating times, blood transfusion, and hospital stay), surgery-related complications, as well as cure and recurrence rates.ResultsA total of 49 articles were available, including 3,014 patients, among which 18 were comparative studies on LSC vs. RSC, and 31 were non-comparative single-arm studies on RSC. For RSC, median operative time was 226 [90-604] minutes, estimated blood loss was 56 [5-1,500] mL, and hospital stay was 1.55 [1-16] days. Intraoperative complications and postoperative complications occurred in 74 (2.7%) and 360 (13.0%) patients, respectively. Of 2,768 RSC patients, 40 had been converted from a robot-assisted approach to other approaches, and 134 of 1,852 patients (7.2%) have recurrent prolapses of any compartment. Compared to LSC, RSC was associated with significantly lower blood loss and lower conversion rate. However, more operative time was observed in RSC. No significant differences were observed in perioperative transfusion, intraoperative and postoperative complications, or objective recurrence between RSC and LSC.ConclusionsRSC's application seems to contribute some advantages compared to conventional laparoscopic surgery, although both approaches appear to promote equivalent clinical outcomes. Notably, heterogeneity among studies might have affected the outcome of the study. Consequently, high-quality and large-sample randomized trials comparing both techniques are necessitated.

Project description:Study objectiveTo prospectively measure trocar site appearances 1 year after surgery in women participants in the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies Trial, a 2-center randomized surgical trial (NCT01124916).DesignSupplementary analysis of a surgical trial that randomized women to robotic or laparoscopic sacrocolpopexy (Canadian Task Force classification I).SettingOperative trial.PatientsWomen undergoing clinically indicated sacrocolpopexy for symptomatic stage ≥II pelvic organ prolapse were randomized to laparoscopic abdominal sacrocolpopexy (LASC) or robotic abdominal sacrocolpopexy (RASC). Trocar skin incision closure was standardized by using Dermabond (Ethicon, Somerville, NJ).Measurements and main resultsPhotographs of all incision sites were taken at baseline (immediately), 6 weeks, 6 months, and 1 year after surgery. Study coordinators scored each incision with the validated Stony Brook Evaluation Scale (SBES), a 5-point wound evaluation scale. We calculated the average of all scars scores per case to determine the percent of optimal wound healing (0%-100%) for each case as well as the proportion of cases meeting 100% wound repair scoring. Wound repair scores across groups were tested with the Wilcoxon rank sum test. The overall proportion of cases in each group meeting "optimal" wound recovery (scores of 100%) was tested with the Fisher exact test. Seventy-eight women with a mean age of 59 years (range, 26-79 years) were randomized to LASC (n = 38) or RASC (n = 40). We did not detect significant differences in baseline characteristics or rates of dropout between the 2 study groups (5 in LASC and 7 in RASC, p = .60). Pain in the initial postoperative period was higher in the robotic arm although groups were similar at 2 weeks. Nearly all cases (75/78) contributed wound repair data (36 laparoscopic and 39 robotic). Laparoscopic surgeries require significantly fewer incisions (median = 4; range, 4-6) than robotic surgeries (median = 5; range, 4-6; p < .001). SBES scores at 6 weeks were not different for LASC and RASC (p = .426). By 6 months, the scores were better in the LASC group (84.8% ± 8.8% vs 78.5% ± 7.2%, p = .031), and this finding remained at 1 year (93.4% ± 7.2% vs 85.9% ± 8.8%, p = .001). The proportion of cases with optimal wound repair (score of 100%) was higher in the laparoscopic arm at 1 year after surgery (12/27 vs 4/33, p = .008).InterventionsWomen were randomized to robotic assisted laparoscopy or laparoscopy.ConclusionWound appearance using the SBES was better in the LASC group, suggesting that there may be alterations in the mechanism for wound initiation and/or healing based on the minimally invasive route used for sacrocolpopexy.

Dataset Information

Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.

Publications

Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.

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