Preoperative Weight Loss for Open Abdominal Wall Reconstruction

• ClinicalTrials.gov Identifier: NCT05925959
• Recruitment Status: Recruiting
• First Posted: June 29, 2023
• Last Update Posted: September 21, 2023
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Benjamin T. Miller, The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Abdominal Wall Hernia	Other: Preoperative Weight Management Program	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The assessor of the patient reported outcomes will be blinded. Hernia recurrence will be assessed by blinded review of CT scans by 3 surgeons.
• Primary Purpose: Treatment
• Official Title: Preoperative Weight Loss for Open Abdominal Wall Reconstruction
• Actual Study Start Date: June 19, 2023
• Estimated Primary Completion Date: June 1, 2027
• Estimated Study Completion Date: June 1, 2027

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Upfront Surgery
Active Comparator: Preoperative Weight Management Program	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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. Cost effective analysis [ Time Frame: 1 year ]
    Perform a formal cost effectiveness analysis.
12. 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
13. 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
14. 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
15. 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
16. 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
17. Urgent repair [ Time Frame: 1 year ]
    Number of patients who require urgent hernia repair in either arm
18. 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
19. 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
20. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Benjamin T Miller, MD; 216 406-8573; millerb35@ccf.org

Contact: Daphne Remulla, MD; 216 399-7047; REMULLD@ccf.org

Locations

United States, Ohio

Cleveland Clinic Main Campus; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Sara Maskal, MD 216-870-5655 MASKALS2@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

Investigators

• Principal Investigator: Benjamin T Miller, MD; The Cleveland Clinic

More Information

• Responsible Party: Benjamin T. Miller, Assistant Professor, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT05925959
• Other Study ID Numbers: 23-418
• First Posted: June 29, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Weight Loss; Hernia, Abdominal; Hernia, Ventral; Internal Hernia; Body Weight Changes; Body Weight; Hernia; Pathological Conditions, Anatomical