Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02365194
Status:
UNKNOWN
Last Update Posted:
2018-05-02
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modifying Risk in Ventral Hernia Patients
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Modifying Risk in Ventral Hernia Patients
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 independent predictors of a successful outcome defined as hernia- and complication free at 2 years. In addition to a frequentist analysis, a Bayesian analysis will be performed. Posterior point estimates, credible intervals, and probability of increase in proportion of patients without hernias or complications will be calculated.
Conclusion:
Prehabilitation may have no impact on outcomes following ventral hernia repair, cause more complications with acute hernia presentation, or prove superior and decrease recurrences and complications compared to standard of care. This randomized controlled trial will provide baseline information on the efficacy of prehabiliation prior to open ventral hernia repair in obese patients.
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 independent predictors of a successful outcome defined as hernia- and complication free at 2 years. In addition to a frequentist analysis, a Bayesian analysis will be performed. Posterior point estimates, credible intervals, and probability of increase in proportion of patients without hernias or complications will be calculated.
Conclusion:
Prehabilitation may have no impact on outcomes following ventral hernia repair, cause more complications with acute hernia presentation, or prove superior and decrease recurrences and complications compared to standard of care. This randomized controlled trial will provide baseline information on the efficacy of prehabiliation prior to open ventral hernia repair in obese patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: