Preoperative Weight Loss for Open Abdominal Wall Reconstruction
- Conditions
- Abdominal Wall Hernia
- Interventions
- Other: Preoperative Weight Management Program
- Registration Number
- NCT05925959
- Lead Sponsor
- The Cleveland Clinic
- Brief Summary
The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.
- Detailed Description
This is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. The study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. The medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 258
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preoperative Weight Management Program Preoperative Weight Management Program -
- Primary Outcome Measures
Name Time Method Abdominal core health-specific quality of life at 1 year 1 year This will be measured at 1 year using the HerQLes survey which is scored from 0-100 with higher scores indicating better quality of life.
- Secondary Outcome Measures
Name Time Method Hernia recurrence at 1 year 1 year This will be based on based on the current consensus definition of hernia recurrence which considers CT scan reviewed by 3 blinded assessors, surgeon clinical exam, and patient-reported bulge.
Patient abdominal wall specific- quality of life with preoperative weight management program 1 year This includes difference in abdominal wall-specific quality of life using the HerQLes score (0-100 with higher scores indicating better abdominal wall-specific quality of life) in the weight loss arm before and after weight loss intervention.
Pain scores 1 year This includes the difference in pain scores using the PROMIS 3a Pain Intensity Score (scored from 30.7-71.8) at baseline, 30-day, and 1 year.
Body weight percentage loss 1 year Proportion of patients achieving a reduction in 5% and 10% body weight at end of 6-month medical weight loss intervention, day of surgery, and 1-year follow-up
Weight management program adherence 1 year Proportion of successful completion of the program (defined as attending at least 4 visits) is associated with lower wound complications, hernia recurrence, or higher HerQLes score at one year
Wound morbidity at 30 days 30 days This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Wound morbidity at 1 year 1 year This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Urgent repair 1 year Number of patients who require urgent hernia repair in either arm
Impact of 10% body weight loss on wound complications 1 year For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare proportion of wound complications
Impact of 10% body weight loss on hernia recurrence 1 year For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare hernia recurrence at one year
Bariatric surgery prior to hernia repair and wounds 1 year Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of wound complications at one year
Bariatric surgery prior to hernia repair and hernia recurrence 1 year Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of hernia recurrence at one year
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life 1 year Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair and HerQLes scores (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year
Body composition changes in weight 1 year This includes comparative mean changes in body weight (kg) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up.
Body composition changes in BMI 1 year This includes comparative mean changes in BMI (kg/m2) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up.
Patient-reported pain changes with preoperative weight management program 1 year This includes difference in pain using the PROMIS 3a Pain Intensity Score (30.7-71.8 with higher scores indicating more pain) in the weight loss arm before and after weight loss intervention.
Patient-reported quality of life changes with preoperative weight management program 1 year This includes difference in overall quality of life using the EQ5D-5L with VAS (scored with an index value and a 0-100 score with higher scores indicating better quality of life) in the weight loss arm before and after weight loss intervention.
Cost effective analysis 1 year Perform a formal cost effectiveness analysis.
Abdominal wall -specific quality of life short-term 30 days This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively.
Impact of 10% body weight loss 1 year For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare HerQLes score (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year
Trial Locations
- Locations (1)
Cleveland Clinic Main Campus
🇺🇸Cleveland, Ohio, United States