Preoperative Weight Management for Hernia Repair

Overseen By Erika Schmidt, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Benjamin T. Miller

Disqualifiers: Pregnancy, Permanent stoma, Mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

258 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a weight management program before hernia surgery can offer the same quality of life benefits as immediate surgery for individuals with obesity. It seeks to determine if focusing on weight management first can enhance outcomes for those undergoing complex abdominal wall reconstruction. The trial includes two groups: one receiving immediate surgery and another participating in a weight management program before surgery. Suitable candidates have a BMI between 40 and 55, are preparing for specific complex hernia repair surgery, and are not planning on weight loss surgery. As an unphased trial, this study provides participants the chance to contribute to valuable research that could improve surgical outcomes for others with similar conditions.

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 prior data suggests that the Preoperative Weight Management Program is safe for patients undergoing hernia repair?

Research has shown that pre-surgery weight management programs are generally safe. Studies have found no major differences in side effects between participants and non-participants. These programs help patients lose significant weight before surgery. For example, one study found that patients lost an average of 26 pounds and maintained most of this weight loss for several years. This indicates that the program not only works in the short term but can also lead to lasting changes. Overall, evidence suggests that these weight management programs are well-tolerated and can be a safe choice for patients seeking to improve their surgery outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Preoperative Weight Management Program for hernia repair because it addresses a critical factor that can influence surgical outcomes: the patient's weight. Traditional hernia repair methods focus solely on the surgical procedure itself, but this program integrates weight management beforehand, which could potentially enhance recovery and reduce complications. By encouraging weight loss before surgery, this approach aims to improve overall health and surgical success, offering a proactive step not typically included in standard hernia care. This innovative angle is what makes the program stand out from existing treatments.

What evidence suggests that this trial's treatments could be effective?

Research has shown that losing weight before complex abdominal wall surgery can greatly improve recovery. In this trial, participants may join the Preoperative Weight Management Program, designed to help patients lose weight before surgery. One study found that patients who lost weight before surgery were more likely to avoid hernias and other complications a month after the operation. Specifically, 69.5% of those who lost weight had better outcomes compared to 58.6% who did not. On average, participants in a pre-surgery weight loss program lost 26 pounds and maintained most of the loss for over 3.5 years. These programs are generally safe and do not increase the risk of complications. This evidence suggests that managing weight before hernia surgery can aid recovery and improve long-term health. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin T Miller, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Upfront Surgery Active Control 1 Intervention

Group II: Preoperative Weight Management Program Active Control 1 Intervention

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+

Published Research Related to This Trial

A free Weight Management Navigator (WMN) program was offered to patients with Class 2 or 3 obesity seeking ventral hernia repair, but only 41.9% of identified patients participated, indicating low enrollment despite the program's accessibility.

Patients who enrolled in the WMN program experienced a mean weight loss of 5.97 kg, significantly more than the 1.8 kg lost by those who did not participate, highlighting the program's effectiveness in promoting weight loss before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a free weight management program "move the needle" for obese patients preparing for hernia surgery?: outcomes of a novel pilot program. Maskal, SM., Boyd-Tressler, AM., Heinberg, LJ., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Medical Weight Management in Bariatric Surgery: a Review and Reconsideration. Tewksbury, C., Williams, NN., Dumon, KR., et al.[2018]

In a study of 776 patients undergoing bariatric surgery, those required to lose weight before surgery (WLG group) did not show improved postoperative outcomes, such as weight loss or resolution of comorbidities, compared to those not required to lose weight (no-WLG group).

The findings suggest that mandated preoperative weight loss goals may not be beneficial and could restrict access to surgery for patients, as there were no significant differences in postoperative morbidity or recovery between the two groups after 4 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Mandated Weight Loss Goals Prior to Bariatric Surgery Improve Postoperative Outcomes? Monfared, S., Athanasiadis, DI., Furiya, A., et al.[2021]

Current literature does not support the effectiveness of mandatory preoperative weight loss regimens in improving weight loss outcomes or long-term success after bariatric surgery, based on a review of existing studies.

While some evidence suggests that achieving preoperative weight loss may reduce postoperative complications, this benefit is inconsistent and requires further research, indicating that mandatory weight loss programs could hinder access to necessary surgical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence Base for Optimal Preoperative Preparation for Bariatric Surgery: Does Mandatory Weight Loss Make a Difference? Kim, JJ.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of a successful medical weight loss program. Altieri, MS., Tuppo, C., Telem, DA., et al.[2015]

In a study of 414 patients undergoing elective hernia repair, those who participated in a preoperative weight loss trial experienced a longer wait for surgery (226 days) compared to those who had immediate surgery (113 days).

Despite some weight loss in the trial group, the overall change in body mass index (BMI) was not significantly different from the nontrial group, and both groups had similar postoperative outcomes, suggesting that preoperative weight loss trials may not improve surgical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Preoperative Weight Loss for Elective Hernia Repair in the Veteran Population. Sun, BJ., Valdez, D., Duong, D., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Preoperative weight loss programs mandated by insurance plans may have a limited impact on reducing perioperative risks and do not effectively promote long-term weight loss outcomes.

Requiring patients to meet preoperative weight loss goals can lead to patient attrition and may ultimately hinder access to necessary weight loss surgery, suggesting that these requirements should be reconsidered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of the Effectiveness of Insurance Requirements for Supervised Weight Loss Prior to Bariatric Surgery. Kushner, BS., Eagon, JC.[2022]

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Preoperative Weight Management for Hernia Repair

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