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Two year outcomes of prehabilitation among obese patients with ventral hernias: a randomized controlled trial (NCT02365194) [with consumer summary] |
Bernardi K, Olavarria OA, Dhanani NH, Lyons N, Holihan JL, Cherla DV, Berger DH, Ko TC, Kao LS, Liang MK |
Annals of Surgery 2022 Feb;275(2):288-294 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)? SUMMARY BACKGROUND DATA: Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR. METHODS: This is the 2-year follow-up of a blinded randomized controlled trial from 2015 to 2017 at a safety-net academic institution. Obese patients (BMI 30 to 40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2-years. Complications included recurrence, re-operation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years. RESULTS: Of the 118 randomized patients, 108 (91.5%) completed a median (range) follow-up of 27.3 (6.2 to 37.4) months. Baseline BMI (mean +/- SD) was similar between groups (36.8 +/- 2.6 versus 37.0 +/- 2.6). More patients in the prehabilitation group underwent emergency surgery (5 versus 1) or dropped out of the program (3 versus 1) compared to standard counseling (13.6% versus 3.4%, p = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% versus 9.1%, p = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% versus 66.1%, p = 0.424, 1.14, 0.88 to 1.47). CONCLUSION: There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR. CLINICAL TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT02365194). CONFLICT OF INTEREST AND SOURCE OF FUNDING: This work was supported by grants awarded to Dr Liang from the Center for Clinical and Translational Sciences (grant number UL1 TR000370) and the National Center for Advancing Translational Sciences (grant number KL2 TR000370). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research or the National Institute of Health. The remaining authors have nothing to disclose. FUNDING: Grants from the Center for Clinical and Translational Sciences (UL1 TR000370) and the National Center for Advancing Translational Sciences (KL2 TR000370).
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