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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 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Awards & 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

Find a Location

Who is running the clinical trial?

Benjamin T. MillerLead Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,053 Previous Clinical Trials
1,370,916 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

Media Library

Preoperative Weight Management Program (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05925959 — N/A
Hernia Research Study Groups: Upfront Surgery, Preoperative Weight Management Program
Hernia Clinical Trial 2023: Preoperative Weight Management Program Highlights & Side Effects. Trial Name: NCT05925959 — N/A
Preoperative Weight Management Program (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05925959 — N/A
~165 spots leftby Jun 2027
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