Modifying Risk in Ventral Hernia Patients

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.

Study Overview

• Status: Unknown
• Conditions: Weight Loss; Hernia, Ventral
• Intervention / Treatment: Behavioral: Prehabilitation; Behavioral: Standard counseling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prehabilitation; physical conditioning and weight loss intervention done pre-operatively	Behavioral: Prehabilitation; information included in arm description
Other: Standard Counseling; initial clinic counseling	Behavioral: Standard counseling; information included in arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who are hernia- and complication-free	2 years after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss (number of participants with weight loss of at least 7%)	number of participants with weight loss of at least 7%	6 months after enrollment
Receipt of elective or emergency surgery	When the patient underwent elective or emergent surgery	6 months after enrollment
surgery-related complications (number of patients who developed infections or other complications related to the surgery)	number of patients who developed infections or other complications related to the surgery	2 years after surgery
hernia-related complications (number of patients who developed complications from their hernia)	number of patients who developed complications from their hernia	2 years after surgery
Functional Status (Quality of life questionnaire responses)	Quality of life questionnaire responses	2 years after surgery
implementation outcomes (difference in costs between the patients in the treatment group and those in the usual care group)	difference in costs between the patients in the treatment group and those in the usual care group	2 years
Physiologic changes (number of pounds lost/gained)	number of pounds lost/gained	2 years after surgery
Metabolic changes (difference in basal metabolic rate before treatment and after treatment)	difference in basal metabolic rate before treatment and after treatment	2 years after surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Mike K Liang, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Prehabilitation; Ventral Hernia
• Additional Relevant MeSH Terms: Body Weight; Pathological Conditions, Anatomical; Hernia, Abdominal; Body Weight Changes; Hernia; Weight Loss; Hernia, Ventral
• Other Study ID Numbers: HSC-MS-14-1025