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Behavioural Intervention
Preoperative Weight Management for Hernia Repair
N/A
Recruiting
Led By Benjamin T Miller, MD
Research Sponsored by Benjamin T. Miller
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial compares weight management to surgery to improve quality of life for obese patients needing abdominal wall reconstruction.
Who is the study for?
This trial is for adults with a BMI between 40-55 who need surgery to repair a complex hernia in the abdominal wall. They must not be candidates for weight loss surgery, unable to get it due to insurance issues, or simply not interested in it.
What is being tested?
The study compares two approaches: an intensive preoperative weight management program versus immediate surgery without prior weight loss. The focus is on whether quality of life after upfront surgery can match that of patients who first lose weight.
What are the potential side effects?
Potential side effects are not specified for this trial but may include typical risks associated with any surgical procedure and possible complications from rapid preoperative weight loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Abdominal core health-specific quality of life at 1 year
Secondary study objectives
Abdominal wall -specific quality of life short-term
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
Bariatric surgery prior to hernia repair and hernia recurrence
+17 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Upfront SurgeryActive Control1 Intervention
Group II: Preoperative Weight Management ProgramActive Control1 Intervention
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Who is running the clinical trial?
Benjamin T. MillerLead Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,051 Previous Clinical Trials
1,370,634 Total Patients Enrolled
23 Trials studying Hernia
5,721 Patients Enrolled for Hernia
Benjamin T Miller, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Hernia
25 Patients Enrolled for Hernia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is between 40-55, and I am not considering weight loss surgery.I need more than one surgery, including one to remove mesh before reconstruction.I am an adult scheduled for a specific hernia repair surgery with mesh.I can't join the Obesity Management Program because I don't have insurance or have a mental health condition.My BMI is either below 40 or above 55.I experience blockages that affect my normal bodily functions.My surgeon says I urgently need surgery.I have a permanent stoma.I have a hernia on one side of my lower back.
Research Study Groups:
This trial has the following groups:- Group 1: Upfront Surgery
- Group 2: Preoperative Weight Management Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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