Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Abdominal Wall Hernia Clinical Trial

Official title:

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925959
• Other study ID #: 23-418
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: September 2023
• Source: The Cleveland Clinic
• Contact: Benjamin T Miller, MD
• Phone: 216 406-8573
• Email: millerb35[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Wall Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Main Campus	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal 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.	1 year
Secondary	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.	1 year
Secondary	Wound morbidity at 30 days	This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.	30 days
Secondary	Wound morbidity at 1 year	This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	30 days
Secondary	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.	1 year
Secondary	Cost effective analysis	Perform a formal cost effectiveness analysis.	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	Urgent repair	Number of patients who require urgent hernia repair in either arm	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year