Prospective Trial Using Gastric Stapling Line Reinforcement With Seamguard in Roux-en-Y Gastric Bypass

This study has been completed.
Sponsor:
Information provided by:
Clinique de l'Anjou
ClinicalTrials.gov Identifier:
NCT01015157
First received: August 5, 2009
Last updated: January 4, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Gastric Bypass
Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Laparoscopic Roux-en-Y Gastric Bypass Outcomes With Systematic Gastric Stapling Line Reinforcement With Seamguard Biomaterial

Resource links provided by NLM:


Further study details as provided by Clinique de l'Anjou:

Primary Outcome Measures:
  • Blood loss volume per and postoperatively, additional hemostatic measures peroperatively, hemoglobin levels postoperatively [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • gastrojejunal anastomosis leakage rate: clinical and radiological [ Time Frame: postoperative day 2 (gastrograffin swallow) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard stapling without reinforcement
Standard Echelon 60 linear stapling with GOLD cartridges
Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesity
Primary bariatric surgery. Standard laparoscopic procedure with linear stapling divising of the stomach (Echelon 60 stapler, GOLD cartridges) with or with Seamguard reinforcement
Other Name: Gore Seamguard biomaterial staple line reinforcement
Active Comparator: Seamguard gastric stapling line reinforcement Procedure: Roux-en-Y laparoscopic gastric bypass for morbid obesity
Primary bariatric surgery. Standard laparoscopic procedure with linear stapling divising of the stomach (Echelon 60 stapler, GOLD cartridges) with or with Seamguard reinforcement
Other Name: Gore Seamguard biomaterial staple line reinforcement

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all primary laparoscopic Roux-en-Y gastric bypasses for morbid obesity

Exclusion Criteria:

  • additional procedures except cholecystectomy, peroperative bleeding from spleen or liver injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015157

Locations
France
Clinique de l'Anjou
Angers, France, 49044
Sponsors and Collaborators
Clinique de l'Anjou
Investigators
Principal Investigator: Philippe A Topart, MD Société de Chirurgie Viscérale
  More Information

No publications provided

Responsible Party: Philippe Topart MD, Société de Chirurgie Viscérale, Clinique de l'Anjou
ClinicalTrials.gov Identifier: NCT01015157     History of Changes
Other Study ID Numbers: SEAM1
Study First Received: August 5, 2009
Last Updated: January 4, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Clinique de l'Anjou:
Gastric bypass
staple line reinforcement
outcomes
per and postoperative blood loss

ClinicalTrials.gov processed this record on April 17, 2014