Preoperative Weight Management for Hernia Repair

Overseen By Daphne Remulla, 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?

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.

Will I have to stop taking my current medications?

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

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{1 3 4 6 8}

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

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 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 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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Preoperative Medical Weight Management in Bariatric Surgery: a Review and Reconsideration. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Predictors of a successful medical weight loss program. [2015]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. France 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Do Mandated Weight Loss Goals Prior to Bariatric Surgery Improve Postoperative Outcomes? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Preoperative Weight Loss for Elective Hernia Repair in the Veteran Population. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Evidence Base for Optimal Preoperative Preparation for Bariatric Surgery: Does Mandatory Weight Loss Make a Difference? [2018]