Dataset Information

Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial.

ABSTRACT:

Importance

Despite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.

Objective

To determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.

Design, setting, and participants

A registry-based, single-blinded, prospective randomized clinical trial at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, completed between September 2017 and January 2020, with a minimum follow-up duration of 30 days. Two surgeons at 1 academic tertiary care hospital. Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair.

Interventions

Patients were randomized to a standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh.

Main outcomes and measures

The trial was powered to detect a 30% difference in the Numerical Rating Scale (NRS-11) on the first postoperative day. Secondary end points included the Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost.

Results

Seventy-five patients completed their minimally invasive hernia repair: 36 laparoscopic and 39 robotic. Baseline demographics and hernia characteristics were comparable. Robotic operations had a longer median operative time (146 vs 94 minutes; P < .001). There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations. There were no significant differences in NRS-11 scores preoperatively or on postoperative days 0, 1, 7, or 30. Specifically, median NRS-11 scores on the first postoperative day were the same (5 vs 5; P = .61). Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores, as well as length of stay and complication rates, were similar. The robotic platform adds cost (total cost ratio, 1.13 vs 0.97; P = .03), driven by the cost of additional operating room time (1.25 vs 0.85; P < .001).

Conclusions and relevance

Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.

Trial registration

ClinicalTrials.gov Identifier: NCT03283982.

SUBMITTER: Petro CC

PROVIDER: S-EPMC7578919 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial.

Petro Clayton C CC Zolin Sam S Krpata David D Alkhatib Hemasat H Tu Chao C Rosen Michael J MJ Prabhu Ajita S AS

JAMA surgery 20210101 1

<h4>Importance</h4>Despite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.<h4>Objective</h4>To determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.<h4>Design, setting, and partic ...[more]

PMID: 33084881

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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:ImportanceDespite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair.ObjectiveTo determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs.Design, setting, and participantsThis multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis.InterventionsStandard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair.Main outcomes and measuresMain outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection.ResultsA total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P < .001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P < .001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P = .004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument.Conclusions and relevanceResults of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons.Trial registrationClinicalTrials.gov Identifier: NCT02816658.

Project description:ImportanceAlthough the use of robotic-assisted ventral hernia repairs has increased significantly over the last decade, the experience surgeons need to achieve comparable outcomes with more established laparoscopic and open approaches has not been well characterized.ObjectiveTo estimate the learning curves for robotic-assisted ventral (incisional and umbilical) hernia repair.Design, setting, and participantsThis retrospective cohort study included Medicare fee-for-service patients (≥18 years) enrolled in Medicare Part A and Part B with no managed care undergoing ventral hernia repairs between 2010 and 2020. Multivariate logistic regression was used to estimate reoperation rates for hernia recurrence, adjusting for patient demographics, comorbidities, mesh placement, and hospital characteristics. Analyses were conducted from October 2023 to July 2024.ExposureIncremental robotic-assisted hernia repair volume.Main outcome and measureReoperation for hernia recurrence within 7 years of index hernia repair.ResultsThis study comprised 160 379 Medicare patients (mean [SD] age, 69 [11] years), of whom 93 272 (58.2%) were female, 13 799 (8.6%) were Black, 3124 (2.0%) were Hispanic, and 138 311 (86.2%) were White. Among these patients, 12 609 (7.9%) underwent robotic-assisted hernia repairs, 32 337 (20.2%) laparoscopic repairs, and 115 433 (71.9%) open repairs. This study also included 23 580 surgeons, with 5074 performing robotic-assisted hernia repairs. The national reoperation rates for hernia recurrence after laparoscopic and open repairs were 12.5% (95% CI, 12.06%-12.94%) and 12.9% (95% CI, 12.70%-13.15%), respectively. Reoperation rates decreased as the number of robotic-assisted cases increased, from 14.2% (95% CI, 13.34%-14.97%) at 10 cases to 7.6% (95% CI, 6.75-8.37) at 50 cases. Surgeons needed at least 19 (95% CI, 16-22) robotic-assisted hernia repairs or 16 (95% CI, 13-19) repairs to achieve outcomes equivalent to those of laparoscopic and open procedures. Few surgeons (285 surgeons [5.7%]) performed enough robotic-assisted ventral hernia repairs to achieve necessary volume nationally to overcome the learning curve.Conclusions and relevanceIn this cohort study of 23 580 surgeons who performed ventral hernia repairs between 2010 and 2020, increasing experience with robotic-assisted hernia repairs was associated with improved long-term reoperation rates for hernia recurrence. However, the majority of surgeons did not perform enough cases to reach reoperation rates equivalent to more established laparoscopic and open approaches.

Dataset Information

Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh: The PROVE-IT Randomized Clinical Trial.

Similar Datasets

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