Modifying Risk in Ventral Hernia Patients

NCT ID: NCT02365194

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-07-31

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.

Conditions

Hernia, Ventral; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prehabilitation

physical conditioning and weight loss intervention done pre-operatively

Group Type: OTHER

Prehabilitation

Intervention Type: BEHAVIORAL

information included in arm description

Standard Counseling

initial clinic counseling

Group Type: OTHER

Standard counseling

Intervention Type: BEHAVIORAL

information included in arm description

Interventions

Prehabilitation

information included in arm description

Intervention Type: BEHAVIORAL

Standard counseling

information included in arm description

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patient desires an elective surgical repair
• Diagnosis of a ventral hernia with width on CT scan of 3-20 cm in diameter
• Age 18 years or greater
• Able to give informed consent
• BMI of 30-40 kg/m2
• Surgical candidate based upon surgeon assessment

Exclusion Criteria

• Patient has a severe comorbid condition likely to limit survival to < 2 years
• Patient has cirrhosis with or without ascites
• Patient has a bowel obstruction, strangulation, peritonitis, or perforation
• Patient has an indication for urgent surgery determined by surgeon such as full-thickness skin breakdown, enterocutaneous fistula, intermittent incarceration, or severe symptoms
• Patient has a local or systemic infection
• Patient is a prisoner
• Patient is pregnant or intends to become pregnant during the study period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Mike K Liang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mike K Liang, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Lyndon B. Johnson General Hospital

Houston, Texas, United States

Countries

United States

References

Bernardi K, Olavarria OA, Dhanani NH, Lyons N, Holihan JL, Cherla DV, Berger DH, Ko TC, Kao LS, Liang MK. Two-year Outcomes of Prehabilitation Among Obese Patients With Ventral Hernias: A Randomized Controlled Trial (NCT02365194). Ann Surg. 2022 Feb 1;275(2):288-294. doi: 10.1097/SLA.0000000000004486.

Reference Type: DERIVED

PMID: 33201119 (View on PubMed)

Liang MK, Bernardi K, Holihan JL, Cherla DV, Escamilla R, Lew DF, Berger DH, Ko TC, Kao LS. Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial. Ann Surg. 2018 Oct;268(4):674-680. doi: 10.1097/SLA.0000000000002961.

Reference Type: DERIVED

PMID: 30048306 (View on PubMed)

Other Identifiers

HSC-MS-14-1025

Identifier Type: -

Identifier Source: org_study_id