Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Abdominal Wall Hernia
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 258 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion criteria
- Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh
- BMI 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery.
Exclusion criteria
- Lack of English language fluency
- Urgent need for repair as determined by surgeon judgement
- Pregnant patients
- Permanent stoma in place
- Isolated flank hernia
- Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction.
- BMI \<40 or \>55 kg/m2
- Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.).
- Obstructive symptoms
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
Upfront Surgery
Not reported in this registry record.
Preoperative Weight Management Program
Not reported in this registry record.
Other: Preoperative Weight Management Program
Preoperative Weight Management Program OTHER
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Abdominal core health-specific quality of life at 1 year
Time frame: 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 measures
Hernia recurrence at 1 year
Time frame: 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.
Wound morbidity at 30 days
Time frame: 30 days
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Wound morbidity at 1 year
Time frame: 1 year
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Body composition changes in weight
Time frame: 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
Time frame: 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 abdominal wall specific- quality of life with preoperative weight management program
Time frame: 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.
Patient-reported pain changes with preoperative weight management program
Time frame: 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
Time frame: 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.
Abdominal wall -specific quality of life short-term
Time frame: 30 days
This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively.
Pain scores
Time frame: 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.
Cost effective analysis
Time frame: 1 year
Perform a formal cost effectiveness analysis.
Body weight percentage loss
Time frame: 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
Time frame: 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
Impact of 10% body weight loss on wound complications
Time frame: 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
Time frame: 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
Impact of 10% body weight loss
Time frame: 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
Urgent repair
Time frame: 1 year
Number of patients who require urgent hernia repair in either arm
Bariatric surgery prior to hernia repair and wounds
Time frame: 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
Time frame: 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
Time frame: 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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
Northwestern UniversityChicago, Illinois, United StatesRecruiting
Cleveland Clinic Main CampusCleveland, Ohio, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Benjamin T. Miller
- Study start
- Jun 19, 2023 Actual
- Primary completion
- Jun 1, 2028 Estimated
- Study completion
- Jun 1, 2028 Estimated
- First posted
- Jun 29, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026