Clinical trial NCT05925959: Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Official title: Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Wall Hernia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Abdominal core health-specific quality of life at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Hernia recurrence at 1 year
timeFrame: 1 year
measure: Wound morbidity at 30 days
timeFrame: 30 days
measure: Wound morbidity at 1 year
timeFrame: 1 year
measure: Body composition changes in weight
timeFrame: 1 year
measure: Body composition changes in BMI
timeFrame: 1 year
measure: Patient abdominal wall specific- quality of life with preoperative weight management program
timeFrame: 1 year
measure: Patient-reported pain changes with preoperative weight management program
timeFrame: 1 year
measure: Patient-reported quality of life changes with preoperative weight management program
timeFrame: 1 year
measure: Abdominal wall -specific quality of life short-term
timeFrame: 30 days
measure: Pain scores
timeFrame: 1 year
measure: Cost effective analysis
timeFrame: 1 year
measure: Body weight percentage loss
timeFrame: 1 year
measure: Weight management program adherence
timeFrame: 1 year
measure: Impact of 10% body weight loss on wound complications
timeFrame: 1 year
measure: Impact of 10% body weight loss on hernia recurrence
timeFrame: 1 year
measure: Impact of 10% body weight loss
timeFrame: 1 year
measure: Urgent repair
timeFrame: 1 year
measure: Bariatric surgery prior to hernia repair and wounds
timeFrame: 1 year
measure: Bariatric surgery prior to hernia repair and hernia recurrence
timeFrame: 1 year
measure: Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Benjamin T Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: