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Behavioural Intervention
Preoperative Weight Management for Hernia Repair
N/A
Recruiting
Led By Benjamin T Miller, MD
Research Sponsored by The Cleveland Clinic
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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abdominal core health-specific quality of life at 1 year
Secondary outcome measures
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 moreTrial Design
2Treatment groups
Active Control
Group I: Upfront SurgeryActive Control1 Intervention
Group II: Preoperative Weight Management ProgramActive Control1 Intervention
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,365,300 Total Patients Enrolled
21 Trials studying Hernia
4,200 Patients Enrolled for Hernia
Benjamin T Miller, MDPrincipal InvestigatorThe Cleveland Clinic
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial still ongoing?
"Indeed, the content from clinicaltrials.gov affirms that this experiment is currently enrolling patients. The trial began to accept participants on June 19th 2023 and was last updated on June 22nd 2023; 258 individuals are required across a single site."
Answered by AI
How many participants are currently receiving treatment as part of this research?
"Affirmative, the information on clinicaltrials.gov suggests that this research endeavour is presently in search of participants. This project was published online on June 19th 2023 and was last revised on June 22nd 2023. The investigation needs 258 subjects from 1 medical site to be enrolled."
Answered by AI
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