Simplified Technique for Performing Laparoscopic Gastric Bypass
Evaluation of a Simplified Technique for Performing Laparoscopic Gastric Bypass in a Teaching Hospital
1 other identifier
observational
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2009
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedJanuary 17, 2025
January 1, 2025
1.7 years
March 8, 2010
January 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complications
Any challenges during the procedure/operation and after
through study completion, an average of 2 years
Secondary Outcomes (2)
Weight
through study completion, an average of 2 years
Operation Time
during surgery/procedure
Study Arms (1)
Gastric Bypass
Patients who have undergone a laparoscopic gastric bypass procedure at using a specific surgical technique developed by the Principal Investigator
Eligibility Criteria
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.
You may qualify if:
- scheduled for a laparoscopic gastric bypass
You may not qualify if:
- Patients undergoing laparoscopic gastric bypass using any method other than the totally linear stapled method
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Related Publications (18)
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PMID: 16925221BACKGROUNDBallantyne GH, Ewing D, Capella RF, Capella JF, Davis D, Schmidt HJ, Wasielewski A, Davies RJ. The learning curve measured by operating times for laparoscopic and open gastric bypass: roles of surgeon's experience, institutional experience, body mass index and fellowship training. Obes Surg. 2005 Feb;15(2):172-82. doi: 10.1381/0960892053268507.
PMID: 15810124BACKGROUNDGonzalez R, Lin E, Venkatesh KR, Bowers SP, Smith CD. Gastrojejunostomy during laparoscopic gastric bypass: analysis of 3 techniques. Arch Surg. 2003 Feb;138(2):181-4. doi: 10.1001/archsurg.138.2.181.
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PMID: 16925374BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew J. Martin, MD
Madigan Army Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgeon
Study Record Dates
First Submitted
March 8, 2010
First Posted
January 17, 2025
Study Start
July 9, 2009
Primary Completion
March 10, 2011
Study Completion
March 10, 2011
Last Updated
January 17, 2025
Record last verified: 2025-01