Longitudinal Sleeve Gastrectomy Study Comparing Posterior Crural Repair Versus No Repair

Completed · Not applicable

Conditions studied: Obesity

In brief

The purpose of this study is to evaluate the superiority of posterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical reflux disease.

Key facts

Study ID

NCT01554553

Run by

The University of Texas Health Science Center, Houston

People needed

100

Starts

2012-01-01

Expected to finish

2018-08-10

Last updated by the study team

2023-05-25

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is between the ages of 21 and 65
• The subject is able to provide informed consent
• The subject is able and willing to comply with the study protocol
• Patients are will to refrain from the use of specified antacid medications such as PPIs (e.g. Nexium, Prilosec, Omeprazole, etc) or H2 blockes (e.g. Pepcid, Zantac, etc)
• The subjects meets the requirement for bariatric surgery as defined by the 1991 NIH consensus on bariatric surgery
• BMI ≥40 or BMI = 35-39 with one or more obesity-related comorbidities.
• Patients should have attempted, and failed, several structured methods of weight loss The subject is approved to have a sleeve gastrectomy

You may not qualify if…

• The subject is not able to provide informed consent
• The subject is not willing to comply with the study protocol
• The subject has had previous foregut (stomach) surgery
• The subject has evidence of a gastric tumor, ulcer, or other abnormalities at the time of EGD that would preclude them from having a sleeve gastrectomy
• Severe esophagitis or Barrett's esophagus will exclude them from the study
• The surgeon concludes that the patient is not a candidate for sleeve gastrectomy based on his clinical judgment

Where it is running

• Minimally Invasive Surgeons of Texas (MIST), Bariatric Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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