肥胖症合并腹壁疝患者行预康复治疗的两年结局：一项随机对照试验（NCT02365194）。

Two-year Outcomes of Prehabilitation Among Obese Patients With Ventral Hernias: A Randomized Controlled Trial (NCT02365194).

机构信息

Surgery Department, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX.

Center for Surgical Trials and Evidence-Based Practice, University of Texas Health Science Center at Houston, Houston, TX.

出版信息

Ann Surg. 2022 Feb 1;275(2):288-294. doi: 10.1097/SLA.0000000000004486.

DOI:10.1097/SLA.0000000000004486

PMID:33201119

Abstract

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 30-40) 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, reoperation, 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 (6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ± 2.6 vs 37.0 ± 2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, P = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, P = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% vs 66.1%, P = 0.424, 1.14, 0.88-1.47).

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).

摘要

目的

确定术前营养咨询和锻炼（预康复）是否能改善肥胖患者接受腹疝修补术（VHR）的结果？

背景资料概要

肥胖和身体状况不佳与 VHR 后发生的并发症有关。目前尚不清楚术前预康复是否能改善肥胖患者接受 VHR 的结果。

方法

这是一项 2015 年至 2017 年在一家安全网学术机构进行的、为期 2 年的双盲随机对照试验的随访。接受 VHR 的肥胖患者（BMI 30-40）被随机分为预康复组和标准咨询组。一旦满足术前要求，即进行选择性 VHR：7%的总体重减轻或 6 个月的咨询且体重无增加。主要结果是 2 年时无疝和无并发症患者的百分比。并发症包括复发、再次手术和网片并发症。使用卡方比较主要结果。我们假设 VHR 肥胖患者的预康复可导致 2 年时更多的无疝和无并发症患者。

结果

在 118 名随机患者中，108 名（91.5%）完成了中位数（范围）为 27.3（6.2-37.4）个月的随访。两组的基线 BMI（平均值±标准差）相似（36.8±2.6 vs 37.0±2.6）。与标准咨询组相比，预康复组有更多的患者接受急诊手术（5 例 vs 1 例）或退出该计划（3 例 vs 1 例）（分别为 13.6% vs 3.4%，P=0.094）。在接受手术的患者中，主要并发症发生率无差异（10.2% vs 9.1%，P=0.438）。2 年时，无疝和无并发症患者的比例无差异（72.9% vs 66.1%，P=0.424，1.14，0.88-1.47）。