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Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Primary Purpose

Abdominal Wall Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preoperative Weight Management Program
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Wall Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic Main CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Upfront Surgery

Preoperative Weight Management Program

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2023
Last Updated
September 18, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05925959
Brief Title
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Official Title
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
June 1, 2027 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Wall Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upfront Surgery
Arm Type
No Intervention
Arm Title
Preoperative Weight Management Program
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Preoperative Weight Management Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Abdominal core health-specific quality of life at 1 year
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hernia recurrence at 1 year
Description
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.
Time Frame
1 year
Title
Wound morbidity at 30 days
Description
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Time Frame
30 days
Title
Wound morbidity at 1 year
Description
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Time Frame
1 year
Title
Body composition changes in weight
Description
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.
Time Frame
1 year
Title
Body composition changes in BMI
Description
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.
Time Frame
1 year
Title
Patient abdominal wall specific- quality of life with preoperative weight management program
Description
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.
Time Frame
1 year
Title
Patient-reported pain changes with preoperative weight management program
Description
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.
Time Frame
1 year
Title
Patient-reported quality of life changes with preoperative weight management program
Description
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.
Time Frame
1 year
Title
Abdominal wall -specific quality of life short-term
Description
This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively.
Time Frame
30 days
Title
Pain scores
Description
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.
Time Frame
1 year
Title
Cost effective analysis
Description
Perform a formal cost effectiveness analysis.
Time Frame
1 year
Title
Body weight percentage loss
Description
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
Time Frame
1 year
Title
Weight management program adherence
Description
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
Time Frame
1 year
Title
Impact of 10% body weight loss on wound complications
Description
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
Time Frame
1 year
Title
Impact of 10% body weight loss on hernia recurrence
Description
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
Time Frame
1 year
Title
Impact of 10% body weight loss
Description
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
Time Frame
1 year
Title
Urgent repair
Description
Number of patients who require urgent hernia repair in either arm
Time Frame
1 year
Title
Bariatric surgery prior to hernia repair and wounds
Description
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
Time Frame
1 year
Title
Bariatric surgery prior to hernia repair and hernia recurrence
Description
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
Time Frame
1 year
Title
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin T Miller, MD
Phone
216 406-8573
Email
millerb35@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Remulla, MD
Phone
216 399-7047
Email
REMULLD@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin T Miller, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Maskal, MD
Phone
216-870-5655
Email
MASKALS2@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Preoperative Weight Loss for Open Abdominal Wall Reconstruction

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