Back to resultsStapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial (STAVHAS)
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Roux en Y Gastric Bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Roux en Y Gastric Bypass, Postoperative complications, Hand sewn anastomosis, Stapled anastomosis
Eligibility Criteria
Inclusion Criteria:
- patients over 18 years
- absence of previous bariatric surgery
Exclusion Criteria:
- less than 18 years old
- coagulation disorders or liver cirrhosis
Sites / Locations
- Hospital Clinico Universitario Virgen de la ArrixacaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
hand sewn anastomosis
stapled anastomosis
Arm Description
Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing
Patients with stapled anastomosis during Roux en Y Gastric Bypass performing
Outcomes
Primary Outcome Measures
postoperative complications
To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis
Secondary Outcome Measures
hospital stay
% of excess weight lost
Full Information
NCT ID
NCT02077517
First Posted
February 24, 2014
Last Updated
March 2, 2014
Sponsor
Hospital Universitario Virgen de la Arrixaca
1. Study Identification
Unique Protocol Identification Number
NCT02077517
Brief Title
Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
Acronym
STAVHAS
Official Title
Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Roux en Y Gastric Bypass, Postoperative complications, Hand sewn anastomosis, Stapled anastomosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hand sewn anastomosis
Arm Type
Active Comparator
Arm Description
Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing
Arm Title
stapled anastomosis
Arm Type
Active Comparator
Arm Description
Patients with stapled anastomosis during Roux en Y Gastric Bypass performing
Intervention Type
Procedure
Intervention Name(s)
Roux en Y Gastric Bypass
Primary Outcome Measure Information:
Title
postoperative complications
Description
To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis
Time Frame
within the first month after surgery
Secondary Outcome Measure Information:
Title
hospital stay
Time Frame
within the first month after surgery
Title
% of excess weight lost
Time Frame
five years after surgery
Other Pre-specified Outcome Measures:
Title
operative time
Time Frame
during surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over 18 years
absence of previous bariatric surgery
Exclusion Criteria:
less than 18 years old
coagulation disorders or liver cirrhosis
Facility Information:
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Israel Abellan, Ph
Phone
615217706
First Name & Middle Initial & Last Name & Degree
Israel Abellan, Ph
12. IPD Sharing Statement
Learn more about this trial
Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
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