Preoperative Weight Management for Hernia Repair
Recruiting in Palo Alto (17 mi)
Overseen byBenjamin T Miller, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Benjamin T. Miller
Disqualifiers: Pregnancy, Permanent stoma, Mental illness, others
No Placebo Group
Trial Summary
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.
What data supports the effectiveness of the treatment Preoperative Weight Management Program for hernia repair?
Is preoperative weight management safe for humans?
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
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
Trial 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 (Behavioural Intervention)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
Cleveland Clinic Main CampusCleveland, OH
Loading ...
Who Is Running the Clinical Trial?
Benjamin T. MillerLead Sponsor
The Cleveland ClinicLead Sponsor
References
Preoperative Medical Weight Management in Bariatric Surgery: a Review and Reconsideration. [2018]Bariatric surgery is the most robust treatment for extreme obesity. The impact of preoperative medical weight management sessions designed, in theory, with the primary goal of promoting preoperative weight loss, is unclear. This paper reviews studies that have investigated the relationship between preoperative weight loss and bariatric surgical outcomes, both with respect to postoperative weight loss and complications. We conclude that the most robust of preoperative interventions has not been implemented or evaluated in a manner which would conclusively assess the value of this element of care. We offer a reconsideration of the role of preoperative medical weight management and provide recommendations for future research in this area.
Predictors of a successful medical weight loss program. [2015]Many practices are creating weight loss programs, in preparation for bariatric surgery or for patients who wish to lose weight without surgery. Preoperative weight loss may be associated with improved postoperative weight loss and resolution of co-morbidities. The aim of this study is to investigate the success of a preoperative weight loss program at a single institution and the variables associated with success in weight loss.
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]Previous studies have shown that a preoperative weight loss is associated with better long-term outcome, fewer complications, and less time in the operating room in bariatric patients. However, preoperative weight loss is hard to achieve in many patients.
Systematic Review and Meta-Analysis of the Effectiveness of Insurance Requirements for Supervised Weight Loss Prior to Bariatric Surgery. [2022]Many insurance plans impose strict criteria mandating preoperative weight loss attempts to limit patient's access to surgery. Preoperative acute weight loss has been hypothesized to reduce perioperative risk and to identify compliant patients who may have improved long-term weight loss. In this review, the evidence from studies examining clinical and weight loss outcomes both with and without preoperative weight loss are summarized. Although preoperative weight loss may have modest impact on some factors related to perioperative conduct, the evidence does not support these programs' effectiveness at promoting long-term weight loss. Provision of weight loss surgery should not be contingent on completion of insurance-mandated weight loss goals preoperatively, and these programs may, through patient attrition, actually do more harm than good.
Can a free weight management program "move the needle" for obese patients preparing for hernia surgery?: outcomes of a novel pilot program. [2022]Obesity is known to result in increased morbidity and risk of hernia recurrence after ventral hernia repair; however, many patients lack the resources to pursue guided weight loss. We sought to evaluate the effectiveness of a free Weight Management Navigator (WMN) program on preoperative weight loss for patients with Class 2 or 3 obesity and complex ventral hernias seeking surgical repair.
Do Mandated Weight Loss Goals Prior to Bariatric Surgery Improve Postoperative Outcomes? [2021]Most patients pursuing bariatric surgery undergo mandated preoperative weight management programs. The purpose of this study was to assess whether preoperative mandated weight loss goals lead to improved perioperative morbidity, postoperative weight loss, and resolution of comorbidities.
Evaluation of Preoperative Weight Loss for Elective Hernia Repair in the Veteran Population. [2018]The safety and efficacy of preoperative weight loss before elective nonbariatric surgery is controversial. We evaluated the effect of planned surgical delay for a preoperative weight loss trial in hernia repairs. Four hundred and fourteen patients undergoing elective hernia repair between July 2008 and May 2012 at a Level 1B VA Medical Center were identified. Included patients were divided into two groups: those who underwent immediate hernia repair (nontrial) and those who underwent weight loss trial before hernia repair (TRIAL). Twenty-two patients were categorized in the TRIAL group, and 392 in nontrial. Time from surgical evaluation to operation was longer in the TRIAL vs nontrial group (226 days vs 113 days, P = 0.001). Outcome measures were similar between groups. Net change in body mass index (BMI) was -2.2 per cent in TRIAL vs -0.86 per cent in nontrial patients (P = 0.440). Of the TRIAL patients, ten obtained a poor result (10% decreased BMI). Weight loss trials in elective hernia patients appear to be safe, although they result in significant delay to surgery and confer no difference in postoperative outcomes. Thus, efficacy of preoperative weight loss trials may be limited.
Evidence Base for Optimal Preoperative Preparation for Bariatric Surgery: Does Mandatory Weight Loss Make a Difference? [2018]Preoperative weight loss regimens prior to bariatric surgery have been a routine and common practice for many centers, in the US and around the world. The mandated participation in such programs has largely been influenced by loco-regional payer requirements. The relationship between adherence to a mandatory weight loss regimen and achieved preoperative weight loss as well as the clinical impact of preoperative weight loss on bariatric outcomes remains uncertain.