Gastric BypassNCT06782256
Simplified Technique for Performing Laparoscopic Gastric Bypass
An observational study of Gastric Bypass and Morbid Obesity, run by Madigan Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Bypass, Morbid Obesity
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2009to 10 Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- scheduled for a laparoscopic gastric bypass
Who cannot join
- Patients undergoing laparoscopic gastric bypass using any method other than the totally linear stapled method
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Bypass, Morbid Obesity
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass | Patients who have undergone a laparoscopic gastric bypass procedure at using a specific surgical technique developed by the Principal Investigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Any challenges during the procedure/operation and after
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
Weight
Patient's weight
Measured: through study completion, an average of 2 years
Operation Time
Time of operation/medical procedure
Measured: during surgery/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start9 Jul 2009
- Primary completion10 Mar 2011
- Study completion10 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Gastric BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Sandra Smith, Madigan Army Medical Center
- Investigators
- Matthew J. Martin, MD, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782256
- Sponsor's protocol ID
- 209085
- Status last verified
- Jan 2025
- First submitted
- 8 Mar 2010
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Menifield CE, Doty N, Fletcher A. Obesity in America. ABNF J. 2008 Summer;19(3):83-8.
PubMed 18717205Drenick EJ, Bale GS, Seltzer F, Johnson DG. Excessive mortality and causes of death in morbidly obese men. JAMA. 1980 Feb 1;243(5):443-5.
PubMed 7351764Flegal 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.
PubMed 17986696Davis 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.
PubMed 16415414Kinzl 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.
PubMed 17476877Perry 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.
PubMed 18156918NIH conference. Gastrointestinal surgery for severe obesity. Consensus Development Conference Panel. Ann Intern Med. 1991 Dec 15;115(12):956-61.
PubMed 1952493Shin 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.
PubMed 16925221Ballantyne 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.
PubMed 15810124Gonzalez 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.
PubMed 12578417Shikora 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.
PubMed 15837887Breaux 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.
PubMed 17623252Hsu 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.
PubMed 16197780Martin 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.
PubMed 16023439Madan 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.
PubMed 18069071
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Simplified Technique for Performing Laparoscopic Gastric Bypass in a Teaching Hospital
- ClinicalTrials.gov ID
- NCT06782256
- Acronym / sponsor ID
- 209085
- Conditions
- Gastric Bypass, Morbid Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Study start
- 9 Jul 2009 (actual)
- Primary completion
- 10 Mar 2011 (actual)
- Study completion
- 10 Mar 2011 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass | – | –Patients who have undergone a laparoscopic gastric bypass procedure at using a specific surgical technique developed by the Principal Investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- scheduled for a laparoscopic gastric bypass
Key exclusion criteria (1 listed)
- Patients undergoing laparoscopic gastric bypass using any method other than the totally linear stapled method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications
Time frame: through study completion, an average of 2 years
Any challenges during the procedure/operation and after
2 secondary outcomes
Weight
Time frame: through study completion, an average of 2 years
Operation Time
Time frame: during surgery/procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Background: PubMed 18717205Menifield CE, Doty N, Fletcher A. Obesity in America. ABNF J. 2008 Summer;19(3):83-8.
- Background: PubMed 7351764Drenick EJ, Bale GS, Seltzer F, Johnson DG. Excessive mortality and causes of death in morbidly obese men. JAMA. 1980 Feb 1;243(5):443-5.
- Background: PubMed 17986696Flegal 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.
- Background: PubMed 16415414Davis 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.
- Background: PubMed 17476877Kinzl 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.
- Background: PubMed 18156918Perry 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.
- Background: PubMed 1952493NIH conference. Gastrointestinal surgery for severe obesity. Consensus Development Conference Panel. Ann Intern Med. 1991 Dec 15;115(12):956-61.
- Background: PubMed 16925221Shin 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.
- Background: PubMed 15810124Ballantyne 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.
- Background: PubMed 12578417Gonzalez 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.
- Background: PubMed 15837887Shikora 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.
- Background: PubMed 17623252Breaux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J. Martin, MD principal investigator
Madigan Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Bypass and Morbid Obesity, run by Madigan Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06782256, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.