258 Participants Needed

Preoperative Weight Management for Hernia Repair

BT
DR
Overseen ByDaphne Remulla, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Benjamin T. Miller
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Preoperative Weight Management Program for hernia repair?

A study on a free Weight Management Navigator program showed it helped patients with severe obesity lose weight before hernia surgery, which is important because obesity can increase the risk of complications and hernia recurrence.12345

Is preoperative weight management safe for humans?

Preoperative weight management programs, including those for hernia repair, appear to be safe for humans, as studies have shown no significant difference in postoperative outcomes between those who participated in weight loss trials and those who did not.13567

How does the Preoperative Weight Management Program treatment differ from other treatments for hernia repair?

The Preoperative Weight Management Program is unique because it offers a free, guided weight loss plan specifically for patients with obesity preparing for hernia surgery, aiming to reduce surgical risks and improve outcomes. Unlike other treatments, it focuses on pre-surgery weight loss to potentially lower the chance of hernia recurrence and complications.12578

What is the purpose of this trial?

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.

Research Team

BT

Benjamin T Miller, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults with a BMI between 40-55 who need surgery to repair a complex hernia in the abdominal wall. They must not be candidates for weight loss surgery, unable to get it due to insurance issues, or simply not interested in it.

Inclusion Criteria

My BMI is between 40-55, and I am not considering weight loss surgery.
I am an adult scheduled for a specific hernia repair surgery with mesh.

Exclusion Criteria

I need more than one surgery, including one to remove mesh before reconstruction.
I can't join the Obesity Management Program because I don't have insurance or have a mental health condition.
My BMI is either below 40 or above 55.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Weight Management

Participants undergo an intensive 6-month medical weight loss program prior to surgery

6 months
Regular visits with physicians, nurse practitioners, and dieticians

Surgery

Participants undergo open retromuscular ventral hernia repair

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including quality of life and wound complications

1 year
Multiple visits over 1 year

Treatment Details

Interventions

  • Preoperative Weight Management Program
Trial Overview The study compares two approaches: an intensive preoperative weight management program versus immediate surgery without prior weight loss. The focus is on whether quality of life after upfront surgery can match that of patients who first lose weight.
Participant Groups
2Treatment groups
Active Control
Group I: Upfront SurgeryActive Control1 Intervention
Group II: Preoperative Weight Management ProgramActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Benjamin T. Miller

Lead Sponsor

Trials
3
Recruited
350+

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Findings from Research

Preoperative medical weight management sessions for patients undergoing bariatric surgery have unclear effects on postoperative outcomes, including weight loss and complications, indicating a need for better evaluation of these interventions.
Current studies have not conclusively assessed the value of preoperative weight loss strategies, suggesting that more robust research is necessary to understand their role in improving surgical results.
Preoperative Medical Weight Management in Bariatric Surgery: a Review and Reconsideration.Tewksbury, C., Williams, NN., Dumon, KR., et al.[2018]
In a study of 133 patients enrolled in a 6-month preoperative weight loss program, only 50.8% successfully lost weight, with an average loss of just 0.1 lbs, indicating that many participants did not achieve significant weight loss before bariatric surgery.
Younger patients aged 30 to 50 years and first-time surgical candidates were more likely to succeed in losing weight, while those seeking revisional surgery had poorer outcomes, suggesting that age and surgical history may influence preoperative weight loss success.
Predictors of a successful medical weight loss program.Altieri, MS., Tuppo, C., Telem, DA., et al.[2015]
In a study of 20 bariatric patients, those who took the weight loss medication sibutramine lost an average of 4.8 kg in 6 weeks, while the control group gained 7.0 kg, highlighting the efficacy of sibutramine in promoting preoperative weight loss.
Patients treated with sibutramine also experienced a decrease in liver size and improved liver function, which contributed to shorter operating times during laparoscopic Roux-en-Y gastric bypass surgery.
Treatment with sibutramine prior to Roux-en-Y gastric bypass leads to an improvement of metabolic parameters and to a reduction of liver size and operative time.Aberle, J., Freier, A., Busch, P., et al.[2021]

References

Preoperative Medical Weight Management in Bariatric Surgery: a Review and Reconsideration. [2018]
Predictors of a successful medical weight loss program. [2015]
Treatment with sibutramine prior to Roux-en-Y gastric bypass leads to an improvement of metabolic parameters and to a reduction of liver size and operative time. [2021]
Systematic Review and Meta-Analysis of the Effectiveness of Insurance Requirements for Supervised Weight Loss Prior to Bariatric Surgery. [2022]
Can a free weight management program "move the needle" for obese patients preparing for hernia surgery?: outcomes of a novel pilot program. [2022]
Do Mandated Weight Loss Goals Prior to Bariatric Surgery Improve Postoperative Outcomes? [2021]
Evaluation of Preoperative Weight Loss for Elective Hernia Repair in the Veteran Population. [2018]
Evidence Base for Optimal Preoperative Preparation for Bariatric Surgery: Does Mandatory Weight Loss Make a Difference? [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security