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Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair

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ClinicalTrials.gov Identifier: NCT02078934
Recruitment Status : Unknown
Verified April 2015 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : March 5, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost 400,000 ventral hernia repairs annually in the United States. There is an even higher incidence of incisional hernia recurrence after prior repair if the patient is obese. Each subsequent hernia repair leads to increased morbidity and durability. It is not infrequent that many surgeons will advise overweight or obese patients to lose substantial weight prior to complex incisional hernia repair.

However, it is quite difficult for any individual to lose more than 8 pounds a month in a safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet and exercise alone. Many patients with incisional hernia are physically debilitated that they cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a technically challenging endeavor since prior abdominal surgeries increase the amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not candidates for laparoscopic weight loss surgery because of inability to tolerate pneumoperitoneum due to underlying physiologic dysfunction.

- Novel minimally invasive endoscopic technique may help obese patients with an incisional hernia lose weight in a safe and rapid fashion. Early case reports and small case series on gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight loss.

Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8 Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11

The intent of this study is not to demonstrate endoscopic suturing to be a primary option for weight-loss surgery. Preliminary reports have shown such procedure is technically feasible but not durable and the effects of the procedure varied widely among the study participants.12 The investigators view this technology as a bridge for morbidly obese patients, who will need subsequent surgery for another surgical disease, to improve their body habitus and decrease their postoperative morbidity and mortality. The aims of the investigators study are:

  • Feasibility of endoscopic gastric sleeve plication
  • Define the technical aspects of endoscopic suturing for sleeve plication
  • Provide long-term follow-up for both weight loss and resolution of their co-morbidities
  • Time from the endoscopic procedure to their incisional hernia repair
  • Photographic evidence of the stomach after endoscopic plication during the incisional hernia repair

There are several advantages for the proposed study. First it avoids entering the intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13, 14

The implications of this study can be far-reaching. Once efficacy is demonstrated where enough weight loss is achieved that patients can safely and quickly undergo their incisional hernia surgery, the investigators can then conduct a retrospective case-control cross-matched study to further delineate its true benefit. If there is a true benefit, then a randomized control study can be employed in the future.


Condition or disease Intervention/treatment Phase
Morbid Obesity Weight Loss Complex Incisional Hernias Procedure: Endoscopic Gastric Plication Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia
Study Start Date : April 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Weight Loss
Patients with complex incisional/ventral hernias who are too obese to undergo hernia repair.
Procedure: Endoscopic Gastric Plication
Evaluate the efficacy of endoscopic suturing for weight loss
Other Names:
  • Endoscopic Sleeve Plication
  • Apollo Suturing




Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 1 Year ]
    We will track patient's weight loss after their endoscopic bariatric surgery.


Secondary Outcome Measures :
  1. Time to Hernia Repair [ Time Frame: 1 year ]
    See the time it takes for the patient from the endoscopic surgery to the actual hernia surgery.


Other Outcome Measures:
  1. Hernia Repair [ Time Frame: 3 years ]
    Success of hernia repair



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) ³35 kg/m2
  • Documented incisional hernia
  • Age ≥ 18 years old

Exclusion Criteria:

  • Prior gastric surgery
  • Prior bariatric surgery
  • Gastroesophageal reflux disease (GERD)
  • Enterocutaneous fistula (ECF)
  • Unable to tolerate general anesthesia
  • Portal Hypertension
  • Underlying coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078934


Contacts
Contact: Matthew Y Lin, MD 4154760972 Matthew.Lin@ucsfmedctr.org

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Matthew YC LIn, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Stanley J. Rogers, MD University of California, San Francisco
Principal Investigator: Jonathan T Carter, MD University of California, San Francisco
Principal Investigator: Matthew YC Lin, MD University of California, San Francisco
Principal Investigator: John P Cello, MD University of California, San Francisco

Publications of Results:
Other Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02078934     History of Changes
Other Study ID Numbers: Endoscopic Gastric Plication
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by University of California, San Francisco:
Surgical Endoscopy
Morbid Obesity
Weight Loss
Bariatrics
Complex incisional hernia with mesh

Additional relevant MeSH terms:
Body Weight
Weight Loss
Hernia
Obesity, Morbid
Incisional Hernia
Signs and Symptoms
Body Weight Changes
Pathological Conditions, Anatomical
Obesity
Overnutrition
Nutrition Disorders
Overweight
Postoperative Complications
Pathologic Processes