Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
Primary Purpose
Internal Hernias
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Closing the mesenteric defects with clips during opration
Sponsored by
About this trial
This is an interventional treatment trial for Internal Hernias focused on measuring Internal Hernias, Clips, Gastric Bypass, Avoid
Eligibility Criteria
Inclusion Criteria:
- All patients who meet the requirements for a Gastric Bypass at Køge Hospital.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria
- Patients who converted to open surgeon
Sites / Locations
- Department of Surgery;Bariatric Clinic, Køge Hospital
- Bariatric clinic, Department of Surgery, Køge hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Inertervention group_Clips to avoid internal herniation
Control group
Arm Description
LRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation.
conventional LRYGB without closure of the mesenteric defects
Outcomes
Primary Outcome Measures
To avoid the risk of Internal Hernias in patient with a Gastric bypass
Secondary Outcome Measures
Postoperative pain score (VAS)
Operative time consumption, the amount of clips, trocar and sutures used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01595230
Brief Title
Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
Official Title
Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Zealand
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internal Hernias
Keywords
Internal Hernias, Clips, Gastric Bypass, Avoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inertervention group_Clips to avoid internal herniation
Arm Type
Experimental
Arm Description
LRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
conventional LRYGB without closure of the mesenteric defects
Intervention Type
Procedure
Intervention Name(s)
Closing the mesenteric defects with clips during opration
Other Intervention Name(s)
Clips, Herniestapler, Internal hernia, Gastric bypass
Intervention Description
The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).
Primary Outcome Measure Information:
Title
To avoid the risk of Internal Hernias in patient with a Gastric bypass
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Postoperative pain score (VAS)
Time Frame
5 years
Title
Operative time consumption, the amount of clips, trocar and sutures used
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
30 days complication
Description
30 days complications:
Anastomotic leak
Bleeding (Hb)
Blood transfusions (MAF)
Ileus due to kinking, blowout of the bypassed stomach
Intraperitoneal abscesses.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who meet the requirements for a Gastric Bypass at Køge Hospital.
Exclusion Criteria:
Patients who do not meet the inclusion criteria
Patients who converted to open surgeon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Kristensen, Doctor
Organizational Affiliation
Department of Surgery, Bariatric Clinic, Koge Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery;Bariatric Clinic, Køge Hospital
City
Køge
State/Province
Sealand
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Bariatric clinic, Department of Surgery, Køge hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
33711136
Citation
Kristensen SD, Gormsen J, Naver L, Helgstrand F, Floyd AK. Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery. Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055.
Results Reference
derived
PubMed Identifier
24947625
Citation
Kristensen SD, Naver L, Jess P, Floyd AK. Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia. Dan Med J. 2014 Jun;61(6):A4854.
Results Reference
derived
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Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
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