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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time of gastric emptying
Time Frame: 6 months post surgery
6 months post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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