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NCT05925959·Not applicable·INTERVENTIONAL

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

LiraglutideOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

258

Locations

2

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

OTHER

Preoperative Weight Management Program

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.

Timeline

From registration to results.

  1. First posted

    Jun 29, 2023

  2. Study start

    Jun 19, 2023

  3. Primary completion

    Jun 1, 2027

  4. Study completion

    Jun 1, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Mar 23, 2026

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

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

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Northwestern University

Chicago, Illinois, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Publications

Results and literature.

PMID 40434485 ↗Remulla D, Miles KS, Carvalho A, Maskal SM, Butsch WS, Beffa LR, Petro CC, Krpata DM, Prabhu AS, Rosen MJ, Miller BT. Preoperative weight loss for open abdominal wall reconstruction: study protocol for a randomized controlled trial. Hernia. 2025 May 28;29(1):187. doi: 10.1007/s10029-025-03375-y.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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