GERD Following Laparoscopic Sleeve Gastrectomy

June 8, 2022 updated by: University of California, San Francisco

Antral Length and GERD Following Sleeve Gastrectomy for Morbid

Laparoscopic Sleeve Gastrectomy (LSG) creates a vertical gastrectomy which results in a narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve resection in each center, this can result in difference of the remaining gastric antrum which may affect gastric emptying time after this procedure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic Sleeve Gastrectomy (LSG), a purely restrictive procedure, has become recently one of the most popular bariatric surgical procedures in this decade because its surgical technique is simple but outcomes in regards to weight loss and co-morbidities improvement are excellent comparable to other procedures. Nevertheless, this procedure carries one potential drawback namely "gastroesophageal reflux disease (GERD). The impact on GERD following LSG are inconsistent . Additionally, the recent literature can be divided into two categories: those that support an increase in GERD prevalence after LSG and those that demonstrate a decrease in GERD prevalence after LSG. Postoperatively, one of the proposed mechanisms for either increased or decreased GERD prevalence is gastric emptying time. Delayed gastric emptying time can contribute to increase intra-gastric volume and pressure resulting in an increase in prevalence of GERD after surgery. On the other hand, accelerated gastric emptying time can cause decrease in GERD prevalence because of decrease in stomach volume and interorgan pressure after operation. In addition, LSG creates a vertical gastrectomy which results in a narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve resection in each center, this can result in difference of the remaining gastric antrum which may affect gastric emptying time after this procedure. The investigators hypothesize that a larger amount of gastric antrum will result in accelerated gastric emptying time which leads to less GERD prevalence. On the contrary, the less the remaining gastric antrum would result in delayed gastric emptying which contribute to more GERD prevalence. The investigators plan on identifying the prevalence of GERD in the patients who undergo LSG comparing those who have the sleeve beginning either 3 cm. or 6 cm. from pylorus. We will utilize 24 hour esophageal pH monitoring, esophageal manometry, upper gastrointestinal scintigraphy and esophagogastroduodenoscopy at preoperatively, 3 and 6 month postoperatively. Ultimately, this study will help further clarify the most proper starting resected point of LSG (3 versus 6 cm. from pylorus) which results in the least GERD prevalence after surgery.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any subject who has already been already cleared for and scheduled to undergo laparoscopic sleeve gastrectomy for the treatment of morbid obesity(Utilizing NIH1991 guideline for bariatric surgery)

Exclusion Criteria:

  1. Patients not meeting entry criteria to undergo bariatric surgery procedures.
  2. Refusal to give informed consent.
  3. Age <18 or >70.
  4. Prior small intestinal or gastric resective surgery
  5. Existing coagulopathy (INR>2.0, platelet count<100,000)
  6. Severe reflux esophagitis.( Los Angeles Classification for erosive esophagitis grade C,D)
  7. Hiatal hernia > 2 cm(according to esophageal manometry or EGD)
  8. Acquired or Congenital Immunodeficiencies
  9. White blood cell count below normal range.
  10. Azotemia - serum creatinine > 2.0 mg/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 cm start of resection
The line of resection for the Laparoscopic Sleeve gastrectomy will start at 3 cm from pylorus (antrum).
Procedure: 3 cm start of resection
Investigators will start the resection of the LSG 3 centimeters from the antrum of the stomach.
Active Comparator: 6 cm start of resection
The line of resection for the Laparoscopic Sleeve gastrectomy will start at 6 cm from pylorus (antrum).
Procedure: 6 cm start of resection
Investigators will start the resection of the LSG 6 centimeters from the antrum of the stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of gastric emptying
Time Frame: 6 months post surgery
6 months post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with GERD
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 133508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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