The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05925959
Recruitment Status : Recruiting
First Posted : June 29, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Benjamin T. Miller, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE June 14, 2023
First Posted Date  ICMJE June 29, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date  ICMJE June 19, 2023
Estimated Primary Completion Date June 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2023)
  • 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.
  • Cost effective analysis [ Time Frame: 1 year ]
    Perform a formal cost effectiveness analysis.
  • 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
  • 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
  • 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
  • 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
  • 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
  • Urgent repair [ Time Frame: 1 year ]
    Number of patients who require urgent hernia repair in either arm
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Official Title  ICMJE Preoperative Weight Loss for Open Abdominal Wall Reconstruction
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Abdominal Wall Hernia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Upfront Surgery
  • Active Comparator: Preoperative Weight Management Program
    Intervention: Other: Preoperative Weight Management Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2023)		 258
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2027
Estimated Primary Completion Date June 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Benjamin T Miller, MD 216 406-8573 millerb35@ccf.org
Contact: Daphne Remulla, MD 216 399-7047 REMULLD@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05925959
Other Study ID Numbers  ICMJE 23-418
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Benjamin T. Miller, The Cleveland Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Cleveland Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin T Miller, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP