Longitudinal Sleeve Gastrectomy Study Comparing Posterior Crural Repair Versus No Repair

NCT ID: NCT01554553

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2018-08-10

Brief Summary

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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Posterior crural repair

Group Type: EXPERIMENTAL

Posterior crural repair

Intervention Type: PROCEDURE

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.

No posteriorcrural repair

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

gastric sleeve with crural repair

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Brad Snyder

MD - Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brad Snyder, MD

Role: PRINCIPAL_INVESTIGATOR

UT Medical School at Houston, Dept. of Surgery

Locations

Minimally Invasive Surgeons of Texas (MIST), Bariatric Clinic

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-11-0605

Identifier Type: -

Identifier Source: org_study_id