Skip to main content
OpenTrials
Completed

NCT Number: NCT06782256

Simplified Technique for Performing Laparoscopic Gastric Bypass

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Bypass Body Weight Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complications

    Time frame: through study completion, an average of 2 years

    Any challenges during the procedure/operation and after

Secondary outcomes

  1. Weight

    Time frame: through study completion, an average of 2 years

    Patient's weight

  2. Operation Time

    Time frame: during surgery/procedure

    Time of operation/medical procedure

Sponsors and collaborators

Lead sponsor

Madigan Army Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.