Recruiting

Preoperative Weight Loss in Patients Undergoing Abdominal Wall Reconstruction

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Study Aim

This study aims to observe if preoperative weight loss improves quality of life in patients undergoing abdominal wall reconstruction, as measured by a survey one year after surgery.

What is being tested

Preoperative Weight Management Program

Other
Who is being recruted

Hernia+1

+ Pathological Conditions, Signs and Symptoms

+ Pathological Conditions, Anatomical

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2023
See protocol details

Summary

Principal SponsorBenjamin T. Miller
Study ContactBenjamin T Miller, MDMore contacts
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 19, 2023

Actual date on which the first participant was enrolled.

This study is exploring whether losing weight before a surgical procedure to fix a ventral hernia can improve outcomes for patients. A ventral hernia is a condition where tissues bulge through an opening in the abdominal wall, and surgery is often needed to repair it. The trial involves patients who need this surgery and compares two groups: one group will undergo a special 6-month weight loss program guided by medical professionals, while the other group will have the surgery without any weight loss requirements. The aim is to see if losing weight beforehand can lead to better recovery and overall health after surgery. Participants in this study will be randomly assigned to one of the two groups. Those in the weight loss program will receive guidance from doctors, nurse practitioners, and dieticians to help them lose weight before their surgery at the Cleveland Clinic. The effectiveness of these approaches will be measured by looking at the participants' quality of life related to their abdominal health one year after the surgery. This will be assessed using a survey that rates their quality of life from 0 to 100, with higher scores indicating a better outcome. This study could potentially lead to improved surgical outcomes and better long-term well-being for patients undergoing abdominal wall reconstruction.

Official TitlePreoperative Weight Loss for Open Abdominal Wall Reconstruction
Principal SponsorBenjamin T. Miller
Study ContactBenjamin T Miller, MDMore contacts
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

258 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HerniaPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, Abdominal

Criteria

2 inclusion criteria required to participate
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

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

9 exclusion criteria prevent from participating
BMI < 40 or > 55 kg/m2

Obstructive symptoms

Isolated flank hernia

Urgent need for repair as determined by surgeon judgement

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Northwestern University

Chicago, United StatesOpen Northwestern University in Google Maps
Recruiting

Cleveland Clinic Main Campus

Cleveland, United States
Recruiting
2 Study Centers