Clinical Trial: Modifying Risk in Ventral Hernia Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Modifying Risk in Ventral Hernia Patients
Brief Summary: A pre-operative physical conditioning and weight loss intervention (prehabilitation) compared to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40 kg/m2) at a safety-net hospital results in a higher proportion of patients being hernia- and complication-free 2 years after surgical consultation.
Detailed Summary:
Background:
Obesity is a risk factor for ventral hernia complications with or without repair, but the management strategy that best balances overall risks and benefits for obese patients with ventral hernias is unknown. The primary aim of this project is to compare the effect of prehabilitation (preoperative physical conditioning and weight loss intervention) versus standard preoperative counseling followed by repair for obese patients (BMI 30-40 kg/m2) with ventral hernias on outcomes.
Methods:
A comprehensive cohort study of obese patients who have ventral hernias will be performed. Within the comprehensive cohort study, patients who are candidates for elective ventral hernia repair will be randomized to a prehabilitation intervention or standard counseling with surgical repair once weight loss goals have been met. All patients will have repair after 6 months even if they have not met their weight loss goals. Patients who are not eligible for the trial or who refuse to participate will be followed in a non-randomized cohort; they will have their hernia repaired based upon current institution standards. (figure 1) The primary outcome of the study will be proportion of patients who are hernia- and complication- free 2 years after surgical consultation. This composite outcome was chosen in order to encompass all clinically important risks and benefits of both operative and non-operative strategies. Based on power calculations(alpha=0.05, beta=0.20), 232 eligible patients are needed assuming a 30% non-enrollment and 50% dropout. Since this is an efficacy trial, analysis will be performed per protocol as well as intention to treat. The primary outcome will be compared using the Cochran-Mantel-Haenszel test. Generalized linear mixed models (GLMMs) will be used to identify indep
Sponsor: The University of Texas Health Science Center, Houston
Current Primary Outcome: Proportion of patients who are hernia- and complication-free [ Time Frame: 2 years after enrollment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Weight loss (number of participants with weight loss of at least 7%) [ Time Frame: 6 months after enrollment ]number of participants with weight loss of at least 7%
- Receipt of elective or emergency surgery [ Time Frame: 6 months after enrollment ]When the patient underwent elective or emergent surgery
- surgery-related complications (number of patients who developed infections or other complications related to the surgery) [ Time Frame: 2 years after surgery ]number of patients who developed infections or other complications related to the surgery
- hernia-related complications (number of patients who developed complications from their hernia) [ Time Frame: 2 years after surgery ]number of patients who developed complications from their hernia
- Functional Status (Quality of life questionnaire responses) [ Time Frame: 2 years after surgery ]Quality of life questionnaire responses
- implementation outcomes (difference in costs between the patients in the treatment group and those in the usual care group) [ Time Frame: 2 years ]difference in costs between the patients in the treatment group and those in the usual care group
- Physiologic changes (number of pounds lost/gained) [ Time Frame: 2 years after surgery ]number of pounds lost/gained
- Metabolic changes (difference in basal metabolic rate before treatment and after treatment) [ Time Frame: 2 years after surgery ]difference in basal metabolic rate before treatment and after treatment
Original Secondary Outcome: Same as current
Information By: The University of Texas Health Science Center, Houston
Dates:
Date Received: February 2, 2015
Date Started: May 2015
Date Completion: July 2017
Last Updated: March 21, 2017
Last Verified: March 2017
