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      Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial

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          Abstract

          Objective

          To determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.

          Design

          Pragmatic, blinded randomized controlled trial.

          Setting

          Multidisciplinary hernia clinics in Houston, USA.

          Participants

          124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.

          Interventions

          Robotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).

          Main outcome measures

          The 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.

          Results

          Patients 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.

          Conclusion

          This 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 registration

          Clinicaltrials.gov NCT03490266.

          Related collections

          Most cited references31

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          Methods for analyzing health care utilization and costs.

          Important questions about health care are often addressed by studying health care utilization. Utilization data have several characteristics that make them a challenge to analyze. In this paper we discuss sources of information, the statistical properties of utilization data, common analytic methods including the two-part model, and some newly available statistical methods including the generalized linear model. We also address issues of study design and new methods for dealing with censored data. Examples are presented.
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            Ventral Hernia Management: Expert Consensus Guided by Systematic Review.

            To achieve consensus on the best practices in the management of ventral hernias (VH).
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              Accounting for centre-effects in multicentre trials with a binary outcome – when, why, and how?

              Background It is often desirable to account for centre-effects in the analysis of multicentre randomised trials, however it is unclear which analysis methods are best in trials with a binary outcome. Methods We compared the performance of four methods of analysis (fixed-effects models, random-effects models, generalised estimating equations (GEE), and Mantel-Haenszel) using a re-analysis of a previously reported randomised trial (MIST2) and a large simulation study. Results The re-analysis of MIST2 found that fixed-effects and Mantel-Haenszel led to many patients being dropped from the analysis due to over-stratification (up to 69% dropped for Mantel-Haenszel, and up to 33% dropped for fixed-effects). Conversely, random-effects and GEE included all patients in the analysis, however GEE did not reach convergence. Estimated treatment effects and p-values were highly variable across different analysis methods. The simulation study found that most methods of analysis performed well with a small number of centres. With a large number of centres, fixed-effects led to biased estimates and inflated type I error rates in many situations, and Mantel-Haenszel lost power compared to other analysis methods in some situations. Conversely, both random-effects and GEE gave nominal type I error rates and good power across all scenarios, and were usually as good as or better than either fixed-effects or Mantel-Haenszel. However, this was only true for GEEs with non-robust standard errors (SEs); using a robust ‘sandwich’ estimator led to inflated type I error rates across most scenarios. Conclusions With a small number of centres, we recommend the use of fixed-effects, random-effects, or GEE with non-robust SEs. Random-effects and GEE with non-robust SEs should be used with a moderate or large number of centres.
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                Author and article information

                Contributors
                Role: general surgery resident
                Role: general surgery resident
                Role: associate professor
                Role: associate professor
                Role: general surgery resident
                Role: associate professor
                Role: assistant professor
                Role: assistant professor
                Role: professor of surgery
                Role: professor of surgery
                Role: associate professor
                Journal
                BMJ
                BMJ
                BMJ-US
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2020
                14 July 2020
                : 370
                : m2457
                Affiliations
                [1 ]Department of Surgery, Lyndon B. Johnson General Hospital, McGovern Medical School at UTHealth, Houston, TX 77026, USA
                [2 ]Center for Surgical Trials and Evidence-Based Practice, McGovern Medical School at UTHealth, Houston, TX, USA
                [3 ]Department of Surgery, Memorial Hermann Texas Medical Center, McGovern Medical School at UTHealth, Houston, TX, USA
                [4 ]Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX, USA
                [5 ]Center for Clinical Research and Evidence Based Medicine, McGovern Medical School at UTHealth, Houston, TX, USA
                [6 ]Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA
                Author notes
                Correspondence to: O A Olavarria oscarolavarria@ 123456hotmail.com (or @oolavarriak on Twitter)
                Author information
                https://orcid.org/0000-0001-87315395
                Article
                olao052670
                10.1136/bmj.m2457
                7359869
                32665218
                bc44278a-13bf-4a79-8dd8-cde844a8948e
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 04 May 2020
                Categories
                Research

                Medicine
                Medicine

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