Longitudinal Sleeve Gastrectomy Study Comparing Posterior Crural Repair Versus No Repair
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||A Prospective Randomized Clinical Trial Comparing Patients Who Have Had Longitudinal Sleeve Gastrectomy With Posterior Crural Repair Versus Without Posterior Crural Repair|
- Change in GERD / GSRS Quality of Life Questionnaire [ Time Frame: 1 questionnaire pre-operatively, and then every 3 months for the 1st year, every 6 months until the third year, and every 12 months until 6 years. ] [ Designated as safety issue: No ]The primary outcome of the study will be the patients' self-assessment of their reflux symptoms as reported with the GSRS quality of life questionnaire that was specifically designed to be used as an outcome measure in clinical trials of intervention in GERD. The final primary outcome will be measured every year to assess allieviation or change of reflux sysmtpms over time and to ensure there is no reoccurence of symptoms.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
|Experimental: Posterior crural repair||
Procedure: Posterior crural repair
All patients receive gastrectomy, however patients randomized to the experimental arm will also receive posterior crural repair to determine if this will reduce GERD post sleeve gastrectomy.
Other Name: gastric sleeve with crural repair
|No Intervention: No posteriorcrural repair|
Longitudinal Sleeve gastrectomy is a type of Bariatric surgery where the stomach is divided vertically, reducing it to about 25% of its original size. Obesity itself is an independent risk factor for Gastroesophageal reflux disease (GERD); however it has been observed in the bariatric surgical community that many Longitudinal Sleeve Gastrectomy (LSG) patients are complaining of persisted GERD symptoms after LSG surgery. The incidence of GERD in these patients have been reported to be as high as 26%. GERD is an uncomfortable and dangerous disease, and if remains unchecked, it can cause ulcer disease, esophagitis, and even esophageal cancer. Because of this, bariatric surgeons want to reduce incidence of GERD after LSG, which led to multiple additions to the LSG procedures, which are currently being examined, namely, combined fundoplication with the sleeve, banded sleeve and a combined hiatal repair with SG. However, there have been no randomized comparative clinical trials to evaluate GERD as an endpoint after LSG.
Of all the possible solutions to treat increased reflux after LSG, mentioned previously, repairing the hiatus at the time of surgery makes the most sense physiologically. LSG dissection requires the obliteration of the left phrenoesophageal ligaments that hold the GE junction in place. This essentially creates a weakness in the hiatus that can lead to hiatal hernia and subsequent reflux disease. Crural repair at the time of surgery strengthens the GE junction and reduces the possibility of hiatal hernia formation. Closing the crus around the esophagus may prevent the sleeve from herniating into the chest and reduces the occurrence of reflux by repositioning the GE junction into it0s normal location in the abdomen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554553
|United States, Texas|
|Minimally Invasive Surgeons of Texas (MIST), Bariatric Clinic|
|Houston, Texas, United States, 77401|
|Principal Investigator:||Brad Snyder, MD||UT Medical School at Houston, Dept. of Surgery|