NCT06782256

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2011

Completed
13.9 years until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

March 8, 2010

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

Related Publications (18)

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    PMID: 18717205BACKGROUND
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    PMID: 7351764BACKGROUND
  • Flegal KM, Graubard BI, Williamson DF, Gail MH. Cause-specific excess deaths associated with underweight, overweight, and obesity. JAMA. 2007 Nov 7;298(17):2028-37. doi: 10.1001/jama.298.17.2028.

    PMID: 17986696BACKGROUND
  • Davis MM, Slish K, Chao C, Cabana MD. National trends in bariatric surgery, 1996-2002. Arch Surg. 2006 Jan;141(1):71-4; discussion 75. doi: 10.1001/archsurg.141.1.71.

    PMID: 16415414BACKGROUND
  • Kinzl JF, Schrattenecker M, Traweger C, Aigner F, Fiala M, Biebl W. Quality of life in morbidly obese patients after surgical weight loss. Obes Surg. 2007 Feb;17(2):229-35. doi: 10.1007/s11695-007-9030-5.

    PMID: 17476877BACKGROUND
  • Perry CD, Hutter MM, Smith DB, Newhouse JP, McNeil BJ. Survival and changes in comorbidities after bariatric surgery. Ann Surg. 2008 Jan;247(1):21-7. doi: 10.1097/SLA.0b013e318142cb4b.

    PMID: 18156918BACKGROUND
  • NIH conference. Gastrointestinal surgery for severe obesity. Consensus Development Conference Panel. Ann Intern Med. 1991 Dec 15;115(12):956-61.

    PMID: 1952493BACKGROUND
  • Shin RB. Evaluation of the learning curve for laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2005 Mar-Apr;1(2):91-4. doi: 10.1016/j.soard.2005.01.003.

    PMID: 16925221BACKGROUND
  • Ballantyne 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: 15810124BACKGROUND
  • Gonzalez 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.

    PMID: 12578417BACKGROUND
  • Shikora SA, Kim JJ, Tarnoff ME, Raskin E, Shore R. Laparoscopic Roux-en-Y gastric bypass: results and learning curve of a high-volume academic program. Arch Surg. 2005 Apr;140(4):362-7. doi: 10.1001/archsurg.140.4.362.

    PMID: 15837887BACKGROUND
  • Breaux JA, Kennedy CI, Richardson WS. Advanced laparoscopic skills decrease the learning curve for laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2007 Jun;21(6):985-8. doi: 10.1007/s00464-007-9203-2. Epub 2007 Feb 16.

    PMID: 17623252BACKGROUND
  • Hsu GP, Morton JM, Jin L, Safadi BY, Satterwhite TS, Curet MJ. Laparoscopic Roux-en-Y gastric bypass: differences in outcome between attendings and assistants of different training backgrounds. Obes Surg. 2005 Sep;15(8):1104-10. doi: 10.1381/0960892055002374.

    PMID: 16197780BACKGROUND
  • Martin RC 2nd, Kehdy FJ, Allen JW. Formal training in advanced surgical technologies enhances the surgical residency. Am J Surg. 2005 Aug;190(2):244-8. doi: 10.1016/j.amjsurg.2005.05.020.

    PMID: 16023439BACKGROUND
  • Madan AK, Harper JL, Tichansky DS. Techniques of laparoscopic gastric bypass: on-line survey of American Society for Bariatric Surgery practicing surgeons. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):166-72; discussion 172-3. doi: 10.1016/j.soard.2007.08.006. Epub 2007 Dec 19.

    PMID: 18069071BACKGROUND
  • Leyba JL, Llopis SN, Isaac J, Aulestia SN, Bravo C, Obregon F. Laparoscopic gastric bypass for morbid obesity-a randomized controlled trial comparing two gastrojejunal anastomosis techniques. JSLS. 2008 Oct-Dec;12(4):385-8.

    PMID: 19275854BACKGROUND
  • Csendes A, Burgos AM, Burdiles P. Incidence of anastomotic strictures after gastric bypass: a prospective consecutive routine endoscopic study 1 month and 17 months after surgery in 441 patients with morbid obesity. Obes Surg. 2009 Mar;19(3):269-73. doi: 10.1007/s11695-008-9625-5. Epub 2008 Aug 12.

    PMID: 18696171BACKGROUND
  • Szomstein S, Whipple OC, Zundel N, Cal P, Rosenthal R. Laparoscopic Roux-en-Y gastric bypass with linear cutter technique: comparison of four-row versus six-row cartridge in creation of anastomosis. Surg Obes Relat Dis. 2006 Jul-Aug;2(4):431-4. doi: 10.1016/j.soard.2006.03.019.

    PMID: 16925374BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew J. Martin, MD

    Madigan Army Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations