Simplified Technique for Performing Laparoscopic Gastric Bypass

January 16, 2025 updated by: Sandra Smith, Madigan Army Medical Center

Evaluation of a Simplified Technique for Performing Laparoscopic Gastric Bypass in a Teaching Hospital

This study will include all eligible patients who have undergone or who will undergo a laparoscopic gastric bypass procedure at Madigan Army Medical Center using a specific surgical technique developed by the Principal Investigator. Traditionally, our surgeons have used a standardized technique that included use of a circular stapler to perform the anastomosis of the stomach pouch to the small bowel. The Principal Investigator developed a new technique with multiple modifications of the previous technique, including use of a totally linear stapled anastomosis. These techniques will be labeled OLD and NEW for the remainder of this document. The NEW technique was first utilized in May 2008 and has now been widely adopted by the majority of bariatric surgeons at Madigan Army Medical Center. This study will include both a retrospective review of all patients who have undergone this procedure, as well as a prospective observational study of all future patients undergoing this procedure. At this time, approximately 75 patients have undergone this procedure and will all be included in the retrospective review. The investigators estimate that 150 to 200 of these procedures will be performed at Madigan per year over the next 2 years, and will be included in the prospective observational arm of the study. The investigators anticipate a total sample number of 400 patients if the investigators collect data for the next two years.

Hypothesis: The NEW technique of gastric bypass allows for safe and rapid performance of a laparoscopic gastric bypass. The NEW technique will result in shorter operative times compared to the OLD technique, and no significant difference in postoperative complications.

Study Overview

Status

Completed

Conditions

Detailed Description

The methods of the retrospective arm of the study will involve abstracting of key variables of interest from review of each patient's electronic medical record, including the inpatient electronic record at the time of surgery and any subsequent readmission, and all outpatient visits identified on AHLTA. The key outcome variables of interest will be the early and late complication profile of this procedure, the impact on weight loss and control of weight-related comorbidities, the operative time required for the procedure, and the operative difficulty of the procedure as assessed by intraoperative complications and blood loss. All data will be abstracted to a standardized spreadsheet maintained by the PI, and a full listing of the study variables is attached. The prospective arm of the study will involve collection of the same data in a prospective manner, with the addition of direct conversations with the operating surgeon and/or resident to clarify any ambiguities in the electronic record.

The data analysis plan will involve simple descriptive statistics for all demographic variables, such as age, body mass index (BMI), gender, etc. Descriptive analysis of outcome data will be performed, including the short and long term complication profile of the NEW operation. Weight loss will be calculated as the percentage of the BMI lost at each time point, and will be analyzed by a paired sample t-test, with significance set at p<0.05. Operative times will be compared between different staff surgeons and different PGY levels using analysis of variance (ANOVA) with post-hoc analysis using Bonferroni test and Tamhanes T2. Complications will be compared among these same groups using chi-square analysis. As the operative times and complication profile associated with the previously performed method of gastric bypass (OLD) are known and have been published, the investigators will also compare our outcomes with this new method to our outcomes with the old method using chi-square, student's t-test, and paired t-test to compare each surgeon's operative times with the old technique and the new technique.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone or who will undergo a laparoscopic gastric bypass procedure at Madigan Army Center using a specific surgical technique developed by the Principal Investigator.

Description

Inclusion Criteria:

  • scheduled for a laparoscopic gastric bypass

Exclusion Criteria:

  • Patients undergoing laparoscopic gastric bypass using any method other than the totally linear stapled method

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

Cohorts and Interventions

Group / Cohort
Gastric Bypass
Patients who have undergone a laparoscopic gastric bypass procedure at using a specific surgical technique developed by the Principal Investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: through study completion, an average of 2 years
Any challenges during the procedure/operation and after
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: through study completion, an average of 2 years
Patient's weight
through study completion, an average of 2 years
Operation Time
Time Frame: during surgery/procedure
Time of operation/medical procedure
during surgery/procedure

Collaborators and Investigators

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

Sponsor

Madigan Army Medical Center

Investigators

  • Principal Investigator: Matthew J. Martin, MD, Madigan Army Medical Center

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 (Actual)

July 9, 2009

Primary Completion (Actual)

March 10, 2011

Study Completion (Actual)

March 10, 2011

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209085

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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