Endoscopic Surgery for Bariatric Revision After Weight Loss Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01871896|
Recruitment Status : Recruiting
First Posted : June 7, 2013
Last Update Posted : July 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity Weight Loss||Device: Endoscopic Suturing to Create Early Satiety||Not Applicable|
The most effective weight loss procedures in the United States are both roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)where the majority are performed laparoscopically. Estimated excess body weight loss (EBWL) is >50% at the end of one year. However, nearly 20% of patients fail to meet the estimated EBWL or they may experience weight gain recidivism. The first step is nutritional counseling, medically supervised diets, and medical therapy. Surgery would be for those who still fail to lose weight despite the aforementioned efforts.
It is hypothesized that failure of weight loss for RYGB is gastrojejunostomy (GJ) dilation defined as >2 cm. Surgical treatment would require revision of this dilation. Unfortunately many of these revision procedures cannot be done laparoscopically given dense intra-abdominal adhesions. This will require conversion to an open surgery in a morbidly obese patient thus raising postoperative morbidity and mortality estimated to range between 15%-50%.
The investigators propose to use the endoscopic suturing device designed by Apollo EndoSurgery to decrease the GJ dilation to 5-6 mm thus causing restriction, delayed food transit time, and promote early satiety. These efforts will limit overall caloric intake thereby promoting weight loss.
It is thought that patients with previous SG may have a dilation of their stomach. The investigators propose a pyloric cerclage using the Apollo EndoSurgery suturing device by decreasing the opening of the pylorus thus achieving the same goals that the investigators proposed above with RYGB revision.
Endoscopic procedures are same day procedures with little morbidity and mortality when compared to laparoscopic or open bariatric surgery revision.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apollo OverStitch for Bariatric Surgery Revision After Weight Loss Failure|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Weight Gain
Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.
Device: Endoscopic Suturing to Create Early Satiety
Evaluating the efficacy of endoscopic suturing for weight loss.
- Weight loss [ Time Frame: 2 years ]We will track patient's weight after their endoscopic bariatric surgery.
- Resolution of Co-morbidities [ Time Frame: 2 years ]We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.
- Tolerance [ Time Frame: 2 years ]We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.
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): NCT01871896
|Contact: Matthew Y Lin, MD||415-476-0972||Matthew.Lin@ucsfmedctr.org|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Principal Investigator: Matthew Y Lin, MD|
|Principal Investigator: Stanley J Rogers, MD|
|Sub-Investigator: Jonathan T Carter, MD|
|Sub-Investigator: John P Cello, MD|
|Principal Investigator:||Stanley J Rogers, MD||University of California, San Francisco|
|Principal Investigator:||Jonathan T Carter, MD||University of California, San Francisco|
|Principal Investigator:||John P Cello, MD||University of California, San Francisco|
|Principal Investigator:||Matthew Lin, MD||University of California, San Francisco|