Dataset Information

Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial.

ABSTRACT:

Objective

Report the 2-year outcomes of a multicenter randomized controlled trial comparing robotic versus laparoscopic intraperitoneal onlay mesh ventral hernia repair.

Background

Ventral hernia repair is one of the most common operations performed by general surgeons. To our knowledge, no studies have been published to date comparing long-term outcomes of laparoscopic versus robotic ventral hernia repair.

Methods

The trial was registered at clinicaltrials.gov (NCT03490266). Clinical outcomes included surgical site infection, surgical site occurrence, hernia occurrence, readmission, reoperation, and mortality.

Results

A total of 175 consecutive patients were approached that were deemed eligible for elective minimally invasive ventral hernia repair. In all, 124 were randomized and 101 completed follow-up at 2 years. Two-year follow-up was completed in 54 patients (83%) in the robotic arm and 47 patients (80%) in the laparoscopic arm. No differences were seen in surgical site infection or surgical site occurrence. Hernia recurrence occurred in 2 patients (4%) receiving robotic repair versus in 6 patients (13%) receiving laparoscopic repair (relative risk: 0.3, 95% CI: 0.06-1.39; P =0.12). No patients (0%) required reoperation in the robotic arm whereas 5 patients (11%) underwent reoperation in the laparoscopic arm ( P =0.019, relative risk not calculatable due to null outcome).

Conclusions

Robotic ventral hernia repair demonstrated at least similar if not improved outcomes at 2 years compared with laparoscopy. There is potential benefit with robotic repair; however, additional multi-center trials and longer follow-up are needed to validate the hypothesis-generating findings of this study.

SUBMITTER: Dhanani NH

PROVIDER: S-EPMC10966958 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial.

Dhanani Naila H NH Lyons Nicole B NB Olavarria Oscar A OA Bernardi Karla K Holihan Julie L JL Shah Shinil K SK Wilson Todd D TD Loor Michele M MM Kao Lillian S LS Liang Mike K MK

Annals of surgery 20230519 2

<h4>Objective</h4>Report the 2-year outcomes of a multicenter randomized controlled trial comparing robotic versus laparoscopic intraperitoneal onlay mesh ventral hernia repair.<h4>Background</h4>Ventral hernia repair is one of the most common operations performed by general surgeons. To our knowledge, no studies have been published to date comparing long-term outcomes of laparoscopic versus robotic ventral hernia repair.<h4>Methods</h4>The trial was registered at clinicaltrials.gov (NCT03490266 ...[more]

PMID: 37203558

Similar Datasets

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:Background:The objective of the present study is to compare the outcomes open PVHR and robotic PVHR. Methods/Design:The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1-5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence. Discussion:Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR. Trial registration:The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.

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.

Project description:BACKGROUND:Laparoscopic repair of ventral and incisional hernias has gained popularity since many studies have reported encouraging results in terms of outcomee and recurrence. Choice of mesh and fixation methods are considered crucial issues in preventing recurrences and complications. Lightweight meshes are considered the first choice due to their biomechanical properties and the ability to integrate into the abdominal wall. Titanium helicoidal tacks still represent the "gold standard" for mesh fixation, even if they have been suggested to be involved in the genesis of post-operative pain and complications. Recently, absorbable tacks have been introduced, under the hypothesis that there will be no need to maintain a permanent fixation device after mesh integration. Nevertheless, there is no evidence that absorbable tacks may guarantee the same results as titanium tacks in terms of strength of fixation and recurrence rates. The primary end point of the present trial is to test the hypothesis that absorbable tacks are non-inferior to titanium tacks in laparoscopic incisional and ventral hernia repair (LIVHR) by lightweight polypropylene mesh, in terms of recurrence rates at 3-year follow-up. Surgical complications, post-operative stay, comfort and pain are secondary end points to be assessed. METHODS/DESIGN:Two hundred and twenty patients with ventral hernia will be randomized into 2 groups: Group A (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by titanium tacks; Group B (110) patients will be submitted to LIVHR by lightweight polypropylene mesh fixed by absorbable tacks. DISCUSSION:A few retrospective studies have reported similar results when comparing absorbable versus non-absorbable tacks in terms of intraoperative and early post-operative outcomes. These studies have the pitfalls to be retrospective evaluation of small series of patients, and the reported results still need to be validated by larger series and prospective studies. The aim of the present trial is to investigate and test the non-inferiority of absorbable versus non-absorbable tacks in terms of hernia recurrence rates, in order to assess whether the use of absorbable tacks may achieve the same results as non-absorbable tacks in mid-term and long-term settings. TRIAL REGISTRATION NUMBER:NCT02076984: 5 June 2014 (ClinicalTrials.gov).

Dataset Information

Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial.

Objective

Background

Methods

Results

Conclusions

Publications

Robotic Versus Laparoscopic Ventral Hernia Repair: Two-Year Results From a Prospective, Multicenter, Blinded Randomized Clinical Trial.

Similar Datasets

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