Hernia, VentralNCT02365194
Modifying Risk in Ventral Hernia Patients
A study testing Prehabilitation and Standard counseling in people with Hernia, Ventral and Weight Loss, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral, Weight Loss
- What is being tested?
- Prehabilitation and Standard counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
About this study
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.
Read the 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
- Being tested
- Prehabilitation, Standard counseling
- Keywords
- Ventral Hernia, Prehabilitation
- Medical subject headings
- Hernia, Ventral, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
information included in arm description
Standard counselingBehavioural
information included in arm description
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Other | physical conditioning and weight loss intervention done pre-operatively Receives: Behavioral: Prehabilitation |
| Standard Counseling | Other | initial clinic counseling Receives: Behavioral: Standard counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are hernia- and complication-free
Measured: 2 years after enrollment
Secondary outcomes (8)
Weight loss (number of participants with weight loss of at least 7%)
number of participants with weight loss of at least 7%
Measured: 6 months after enrollment
Receipt of elective or emergency surgery
When the patient underwent elective or emergent surgery
Measured: 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
Measured: 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
Measured: 2 years after surgery
Functional Status (Quality of life questionnaire responses)
Quality of life questionnaire responses
Measured: 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
Measured: 2 years
Physiologic changes (number of pounds lost/gained)
number of pounds lost/gained
Measured: 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
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike K Liang, The University of Texas Health Science Center, Houston
- Investigators
- Mike K Liang, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365194
- Sponsor's protocol ID
- HSC-MS-14-1025
- Status last verified
- Apr 2018
- First submitted
- 2 Feb 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33201119Liang 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.
PubMed 30048306
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying Risk in Ventral Hernia Patients
- ClinicalTrials.gov ID
- NCT02365194
- Acronym / sponsor ID
- HSC-MS-14-1025
- Conditions
- Hernia, Ventral, Weight Loss
- Keywords
- Ventral Hernia, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Other | Behavioral: Prehabilitationphysical conditioning and weight loss intervention done pre-operatively |
| Standard Counseling | Other | Behavioral: Standard counselinginitial clinic counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitationinformation included in arm description | Behavioural | Prehabilitation |
| Standard counselinginformation included in arm description | Behavioural | Standard Counseling |
Primary outcome
Proportion of patients who are hernia- and complication-free
Time frame: 2 years after enrollment
8 secondary outcomes
Weight loss (number of participants with weight loss of at least 7%)
Time frame: 6 months after enrollment
Receipt of elective or emergency surgery
Time frame: 6 months after enrollment
surgery-related complications (number of patients who developed infections or other complications related to the surgery)
Time frame: 2 years after surgery
hernia-related complications (number of patients who developed complications from their hernia)
Time frame: 2 years after surgery
Functional Status (Quality of life questionnaire responses)
Time frame: 2 years after surgery
implementation outcomes (difference in costs between the patients in the treatment group and those in the usual care group)
Time frame: 2 years
Physiologic changes (number of pounds lost/gained)
Time frame: 2 years after surgery
Metabolic changes (difference in basal metabolic rate before treatment and after treatment)
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 33201119Bernardi 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.
- Derived from this study: PubMed 30048306Liang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike K Liang, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation and Standard counseling in people with Hernia, Ventral and Weight Loss, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are hernia- and complication-free (time frame: 2 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02365194, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.