Longitudinal Sleeve Gastrectomy Study Comparing Posterior Crural Repair Versus No Repair

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Brad Snyder, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01554553
First received: February 24, 2012
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Obesity
Procedure: Posterior crural repair

Study Type: Interventional
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

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 to allieviation of reflux sysmtpms and to ensure there is no reoccurence of symptoms.


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • 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

EXCLUSION CRITERIA:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554553

Locations
United States, Texas
Minimally Invasive Surgeons of Texas (MIST), Bariatric Clinic
Houston, Texas, United States, 77401
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Brad Snyder, MD UT Medical School at Houston, Dept. of Surgery
  More Information

No publications provided

Responsible Party: Brad Snyder, MD - Principal Investigator, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01554553     History of Changes
Other Study ID Numbers: HSC-MS-11-0605
Study First Received: February 24, 2012
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Sleeve gastrectomy
Posterior crural repair

ClinicalTrials.gov processed this record on September 22, 2014