Recruiting NA Abdominal Wall Hernia

New treatment option for Abdominal Wall Hernia

Official title Preoperative Weight Loss for Open Abdominal Wall Reconstruction

ClinicalTrials.gov ID: NCT05925959

What this study is testing

What it's testing
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.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and...
  • 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...

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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...
What rules you out
  • 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 \ 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

The study team makes the final eligibility decision.

Where it's taking place

  • Chicago, Illinois, United States
  • Cleveland, Ohio, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chicago, Illinois, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.