Gastric BypassNCT01015157
Prospective Trial Using Gastric Stapling Line Reinforcement With Seamguard in Roux-en-Y Gastric Bypass
A study testing Roux-en-Y laparoscopic gastric bypass for morbid obesity in people with Gastric Bypass, run by Clinique de l'Anjou at 1 site in France.
Trial summary
Study objectives : Primary endpoint is to a assess the change in blood loss (originating from stapling the stomach) with the use of Seamguard reinforcement Secondary endpoint is to evaluate the difference in leak rate Methods : Prospective. Randomized study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Bypass
- What is being tested?
- Roux-en-Y laparoscopic gastric bypass for morbid obesity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Dec 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all primary laparoscopic Roux-en-Y gastric bypasses for morbid obesity
Who cannot join
- additional procedures except cholecystectomy, peroperative bleeding from spleen or liver injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Roux-en-Y Gastric Bypass Outcomes With Systematic Gastric Stapling Line Reinforcement With Seamguard Biomaterial
Study objectives :
Primary endpoint is to a assess the change in blood loss (originating from stapling the stomach) with the use of Seamguard reinforcement Secondary endpoint is to evaluate the difference in leak rate
Read more
Methods :
Prospective. Randomized study. Published data does not allow for clear determination of the number of patients required for the study. Based on our own experience. The investigators estimate that the average postoperative blood loss is 200ml with a standard deviation of 100ml over 3 days. Based on this assumption. A total number of patients (control + Seamguard groups) of 60 is required if the expected reduction of the mean drainage volume is 100ml and 82 patients for an expected drainage volume reduction of 85ml.
All patients candidates to a laparoscopic gastric bypass will be enrolled in the study Under the conditions this is a primary bariatric procedure (no revision allowed)., no history of hiatal surgery such as anti-reflux nor significant upper abdominal surgery. The only associated surgical procedure allowed is the cholecystectomy.
Patients' inclusion :
Will be done immediately before surgical procedure following acceptance of a written consent.
Bleeding from liver or slpeen injury will lead to patient's exclusion.
Methods :
Surgical procedures are identical for the 2 surgeons of the study (GB and PT) with 30-50ml gastric pouch. Linear. side to side. Antegastric and antecolic gastrojejunal anstomosis . Use of Echelon 60 linear stapler with GOLD cartridges on stomach. Blue to perform the gastrojejunal anastomosis and white on Small bowel. Peroperativeblood loss and need to apply clips or stitches on the gastric staple line are recorded. Operation time and patient information (BMI. Comorbidities) are recorded as well any noticeable or unexpected event.
Postoperative blood loss is assessed by at least 1 abdominal closed circuit suction drain left for a minimum of 3 days (removal on postop day 3 at the earliest).
In addition hemoglobin and red cell count is performed on postop day 1 and 2. Absence of leakage is confirmed by methylene blue test perop as well as on postop day 1 before resuming fluids and on postop day 2 by a gastrograffin swallow. Drinks and food are resumed according to the standard practice between postop day 1 and postop day 2.
Duration of the hospital stay and postoperative course will be documented. Early follow up is clinically done at 1 month postop without any specific radiological or biological examination.
Data collection Will be done on a form during and after the procedure
BLOOD LOSS : peroperative volume as well as daily drainage output (postop day 1. 2 and 3) as well as the sum of the 3 postop days.
Hemoglobin change is recorded on day 1 and 2. Need to leave drain(s) for more than 3 days is recorded.
Study completion :
Estimated time to complete the study based on the current experience is between 5 and 7 months. Sudy is closed 1 month after the last inclusion.
- Conditions
- Gastric Bypass
- Being tested
- Roux-en-Y laparoscopic gastric bypass for morbid obesity
- Keywords
- Gastric bypass, staple line reinforcement, outcomes, per and postoperative blood loss
- Medical subject headings
- Progressive Encephalomyelitis with Rigidity, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y laparoscopic gastric bypass for morbid obesityProcedure or surgery
Also called Gore Seamguard biomaterial staple line reinforcement
Primary bariatric surgery. Standard laparoscopic procedure with linear stapling divising of the stomach (Echelon 60 stapler, GOLD cartridges) with or with Seamguard reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Standard stapling without reinforcement | Active comparator | Standard Echelon 60 linear stapling with GOLD cartridges Receives: Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesity |
| Seamguard gastric stapling line reinforcement | Active comparator | Not described Receives: Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss volume per and postoperatively, additional hemostatic measures peroperatively, hemoglobin levels postoperatively
Measured: 3 days postoperatively
Secondary outcomes (1)
gastrojejunal anastomosis leakage rate: clinical and radiological
Measured: postoperative day 2 (gastrograffin swallow)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique de l'Anjou
- Sponsor type
- University, hospital or other
- Investigators
- Philippe A Topart, MD, Principal investigator, Société de Chirurgie Viscérale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015157
- Sponsor's protocol ID
- SEAM1
- Status last verified
- Jan 2010
- First submitted
- 5 Aug 2009
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Roux-en-Y Gastric Bypass Outcomes With Systematic Gastric Stapling Line Reinforcement With Seamguard Biomaterial
- ClinicalTrials.gov ID
- NCT01015157
- Acronym / sponsor ID
- SEAM1
- Conditions
- Gastric Bypass
- Keywords
- Gastric bypass, staple line reinforcement, outcomes, per and postoperative blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Clinique de l'AnjouUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Nov 2009 (estimated)
- 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.
Study objectives :
Primary endpoint is to a assess the change in blood loss (originating from stapling the stomach) with the use of Seamguard reinforcement Secondary endpoint is to evaluate the difference in leak rate
Methods :
Prospective. Randomized study. Published data does not allow for clear determination of the number of patients required for the study. Based on our own experience. The investigators estimate that the average postoperative blood loss is 200ml with a standard deviation of 100ml over 3 days. Based on this assumption. A total number of patients (control + Seamguard groups) of 60 is required if the expected reduction of the mean drainage volume is 100ml and 82 patients for an expected drainage volume reduction of 85ml.
All patients candidates to a laparoscopic gastric bypass will be enrolled in the study Under the conditions this is a primary bariatric procedure (no revision allowed)., no history of hiatal surgery such as anti-reflux nor significant upper abdominal surgery. The only associated surgical procedure allowed is the cholecystectomy.
Patients' inclusion :
Will be done immediately before surgical procedure following acceptance of a written consent.
Bleeding from liver or slpeen injury will lead to patient's exclusion.
Methods :
Surgical procedures are identical for the 2 surgeons of the study (GB and PT) with 30-50ml gastric pouch. Linear. side to side. Antegastric and antecolic gastrojejunal anstomosis . Use of Echelon 60 linear stapler with GOLD cartridges on stomach. Blue to perform the gastrojejunal anastomosis and white on Small bowel. Peroperativeblood loss and need to apply clips or stitches on the gastric staple line are recorded. Operation time and patient information (BMI. Comorbidities) are recorded as well any noticeable or unexpected event.
Postoperative blood loss is assessed by at least 1 abdominal closed circuit suction drain left for a minimum of 3 days (removal on postop day 3 at the earliest).
In addition hemoglobin and red cell count is performed on postop day 1 and 2. Absence of leakage is confirmed by methylene blue test perop as well as on postop day 1 before resuming fluids and on postop day 2 by a gastrograffin swallow. Drinks and food are resumed according to the standard practice between postop day 1 and postop day 2.
Duration of the hospital stay and postoperative course will be documented. Early follow up is clinically done at 1 month postop without any specific radiological or biological examination.
Data collection Will be done on a form during and after the procedure
BLOOD LOSS : peroperative volume as well as daily drainage output (postop day 1. 2 and 3) as well as the sum of the 3 postop days.
Hemoglobin change is recorded on day 1 and 2. Need to leave drain(s) for more than 3 days is recorded.
Study completion :
Estimated time to complete the study based on the current experience is between 5 and 7 months. Sudy is closed 1 month after the last inclusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard stapling without reinforcement | Active comparator | Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesityStandard Echelon 60 linear stapling with GOLD cartridges |
| Seamguard gastric stapling line reinforcement | Active comparator | Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all primary laparoscopic Roux-en-Y gastric bypasses for morbid obesity
Key exclusion criteria (1 listed)
- additional procedures except cholecystectomy, peroperative bleeding from spleen or liver injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y laparoscopic gastric bypass for morbid obesityAlso: Gore Seamguard biomaterial staple line reinforcementPrimary bariatric surgery. Standard laparoscopic procedure with linear stapling divising of the stomach (Echelon 60 stapler, GOLD cartridges) with or with Seamguard reinforcement | Procedure or surgery | Seamguard gastric stapling line reinforcement, Standard stapling without reinforcement |
Primary outcome
Blood loss volume per and postoperatively, additional hemostatic measures peroperatively, hemoglobin levels postoperatively
Time frame: 3 days postoperatively
1 secondary outcome
gastrojejunal anastomosis leakage rate: clinical and radiological
Time frame: postoperative day 2 (gastrograffin swallow)
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 5 Jan 2010.
Related trials for Gastric Bypass
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Enrolling by invitation
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Obesity, Morbid, Metabolic Syndrome
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
Weight Regain, Weight Loss
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.
Philippe A Topart, MD principal investigator
Société de Chirurgie Viscérale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y laparoscopic gastric bypass for morbid obesity in people with Gastric Bypass, run by Clinique de l'Anjou at 1 site in France.
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 5 Jan 2010. 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 France. 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?
Blood loss volume per and postoperatively, additional hemostatic measures peroperatively, hemoglobin levels postoperatively (time frame: 3 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2010.