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NCT Number: NCT05925959

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

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.

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Key information

Conditions

Abdominal Wall Hernia Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative Weight Management Program

Other

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin T Miller, MD

CONTACT

[email protected]

216 406-8573

Erika Schmidt, MD

CONTACT

[email protected]

2163723107

Sponsors and collaborators

Lead sponsor

Benjamin T. Miller

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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