Not a traditional drug phase: Preoperative Weight Management Program for Abdominal Wall Hernia
The goal of this randomly assigned 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.
Official registry: https://clinicaltrials.gov/study/NCT05925959 · Benjamin T. Miller · enrollment listed as 258
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Preoperative Weight Management Program. The registry lists allocation as randomized. The goal of this randomly assigned controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction.
They plan to enroll about 258 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Interventions: Preoperative Weight Management Program
Primary outcome (registry wording): Abdominal core health-specific quality of life at 1 year
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh
- body-mass index (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
Who the registry excludes
- Lack of English language fluency
- Urgent need for repair as determined by surgeon judgement
- 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
- body-mass index (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.)
Public study contact (from the registry)
Benjamin T Miller, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- Northwestern University — Chicago, Illinois (recruiting)
- Cleveland Clinic Main Campus — Cleveland, Ohio (recruiting)
FAQ about this NCT record
Is NCT05925959 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05925959?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05925959?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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