Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

Internal Hernias Clinical Trial

Official title:

Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01595230
• Other study ID #: SJ-284
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2012
• Est. completion date: January 2023

Study information

• Verified date: March 2020
• Source: Region Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 405
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Internal Hernias

Intervention

Procedure:
• Closing the mesenteric defects with clips during opration
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).

Locations

Country	Name	City	State
Denmark	Bariatric clinic, Department of Surgery, Køge hospital	Køge
Denmark	Department of Surgery;Bariatric Clinic, Køge Hospital	Køge	Sealand

Sponsors (1)

Lead Sponsor	Collaborator
Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 days complication	30 days complications: Anastomotic leak; Bleeding (Hb); Blood transfusions (MAF); Ileus due to kinking, blowout of the bypassed stomach; Intraperitoneal abscesses.	3 years
Primary	To avoid the risk of Internal Hernias in patient with a Gastric bypass		5 year
Secondary	Postoperative pain score (VAS)		5 years
Secondary	Operative time consumption, the amount of clips, trocar and sutures used		3 years