Modifying Risk in Ventral Hernia Patients
Primary Purpose
Hernia, Ventral, Weight Loss
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation
Standard counseling
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Ventral focused on measuring Ventral Hernia, Prehabilitation
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
Sites / Locations
- Lyndon B. Johnson General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Prehabilitation
Standard Counseling
Arm Description
physical conditioning and weight loss intervention done pre-operatively
initial clinic counseling
Outcomes
Primary Outcome Measures
Proportion of patients who are hernia- and complication-free
Secondary Outcome Measures
Weight loss (number of participants with weight loss of at least 7%)
number of participants with weight loss of at least 7%
Receipt of elective or emergency surgery
When the patient underwent elective or emergent surgery
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
hernia-related complications (number of patients who developed complications from their hernia)
number of patients who developed complications from their hernia
Functional Status (Quality of life questionnaire responses)
Quality of life questionnaire responses
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
Physiologic changes (number of pounds lost/gained)
number of pounds lost/gained
Metabolic changes (difference in basal metabolic rate before treatment and after treatment)
difference in basal metabolic rate before treatment and after treatment
Full Information
NCT ID
NCT02365194
First Posted
February 2, 2015
Last Updated
April 30, 2018
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02365194
Brief Title
Modifying Risk in Ventral Hernia Patients
Official Title
Modifying Risk in Ventral Hernia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral, Weight Loss
Keywords
Ventral Hernia, Prehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
284 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Other
Arm Description
physical conditioning and weight loss intervention done pre-operatively
Arm Title
Standard Counseling
Arm Type
Other
Arm Description
initial clinic counseling
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation
Intervention Description
information included in arm description
Intervention Type
Behavioral
Intervention Name(s)
Standard counseling
Intervention Description
information included in arm description
Primary Outcome Measure Information:
Title
Proportion of patients who are hernia- and complication-free
Time Frame
2 years after enrollment
Secondary Outcome Measure Information:
Title
Weight loss (number of participants with weight loss of at least 7%)
Description
number of participants with weight loss of at least 7%
Time Frame
6 months after enrollment
Title
Receipt of elective or emergency surgery
Description
When the patient underwent elective or emergent surgery
Time Frame
6 months after enrollment
Title
surgery-related complications (number of patients who developed infections or other complications related to the surgery)
Description
number of patients who developed infections or other complications related to the surgery
Time Frame
2 years after surgery
Title
hernia-related complications (number of patients who developed complications from their hernia)
Description
number of patients who developed complications from their hernia
Time Frame
2 years after surgery
Title
Functional Status (Quality of life questionnaire responses)
Description
Quality of life questionnaire responses
Time Frame
2 years after surgery
Title
implementation outcomes (difference in costs between the patients in the treatment group and those in the usual care group)
Description
difference in costs between the patients in the treatment group and those in the usual care group
Time Frame
2 years
Title
Physiologic changes (number of pounds lost/gained)
Description
number of pounds lost/gained
Time Frame
2 years after surgery
Title
Metabolic changes (difference in basal metabolic rate before treatment and after treatment)
Description
difference in basal metabolic rate before treatment and after treatment
Time Frame
2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike K Liang, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon B. Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33201119
Citation
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.
Results Reference
derived
PubMed Identifier
30048306
Citation
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.
Results Reference
derived
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Modifying Risk in Ventral Hernia Patients
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