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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
258
The medical obesity intervention is comprised of monthly visits with an obesity medicine (OM) provider +/- a registered dietitian (in person or virtual). Lifestyle modifications (nutrition, physical activity, stress, sleep), appetite control, and medication side effects will be addressed in all visits. At initial visit, patients will evaluated in person by an OM provider +/- registered dietitian. An individualized intense lifestyle intervention will be implemented with the addition of an anti-obesity medication (phentermine, naltrexone/bupropion, phentermine/topiramate, liraglutide, semaglutide, etc). Medication use will be based on disease risk, patient preference, severity of obesity, contraindications, potential drug interactions and insurance coverage. A diet recommendation will be tailored to the patient's medical and food allergy history. Weight and vital signs will be monitored at each visit. Participants will have a total of 5 follow-up monthly encounters, every 30 +/- 7 days.
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
RECRUITINGAbdominal core health-specific quality of life at 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.
Time frame: 1 year
Hernia recurrence at 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.
Time frame: 1 year
Wound morbidity at 30 days
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Time frame: 30 days
Wound morbidity at 1 year
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Time frame: 1 year
Body composition changes in weight
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.
Time frame: 1 year
Body composition changes in BMI
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.
Time frame: 1 year
Patient abdominal wall specific- quality of life with preoperative weight management program
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 year
Patient-reported pain changes with preoperative weight management program
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.
Time frame: 1 year
Patient-reported quality of life changes with preoperative weight management program
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.
Time frame: 1 year
Abdominal wall -specific quality of life short-term
This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively.
Time frame: 30 days
Pain scores
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.
Time frame: 1 year
Cost effective analysis
Perform a formal cost effectiveness analysis.
Time frame: 1 year
Body weight percentage loss
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
Time frame: 1 year
Weight management program adherence
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
Time frame: 1 year
Impact of 10% body weight loss on wound complications
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
Time frame: 1 year
Impact of 10% body weight loss on hernia recurrence
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
Time frame: 1 year
Impact of 10% body weight loss
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
Time frame: 1 year
Urgent repair
Number of patients who require urgent hernia repair in either arm
Time frame: 1 year
Bariatric surgery prior to hernia repair and wounds
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
Time frame: 1 year
Bariatric surgery prior to hernia repair and hernia recurrence
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
Time frame: 1 year
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
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
Time frame: 1 year