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

• ClinicalTrials.gov Identifier: NCT01595230
• Recruitment Status: Active, not recruiting
• First Posted: May 10, 2012
• Last Update Posted: April 1, 2020
• Sponsor: Region Zealand
• Information provided by (Responsible Party): Sara Kristensen, Region Zealand

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

Condition or disease	Intervention/treatment	Phase
Internal Hernias	Procedure: Closing the mesenteric defects with clips during opration	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 405 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
• Study Start Date: May 2012
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Inertervention group_Clips to avoid internal herniation; 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.	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).; Other Name: Clips, Herniestapler, Internal hernia, Gastric bypass
No Intervention: Control group; conventional LRYGB without closure of the mesenteric defects

Outcome Measures

Primary Outcome Measures :

1. To avoid the risk of Internal Hernias in patient with a Gastric bypass [ Time Frame: 5 year ]

Secondary Outcome Measures :

1. Postoperative pain score (VAS) [ Time Frame: 5 years ]
2. Operative time consumption, the amount of clips, trocar and sutures used [ Time Frame: 3 years ]

Other Outcome Measures:

1. 30 days complication [ Time Frame: 3 years ]

   30 days complications:

   • Anastomotic leak
   • Bleeding (Hb)
   • Blood transfusions (MAF)
   • Ileus due to kinking, blowout of the bypassed stomach
   • Intraperitoneal abscesses.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Denmark

Department of Surgery;Bariatric Clinic, Køge Hospital

Køge, Sealand, Denmark, 4600

Bariatric clinic, Department of Surgery, Køge hospital

Køge, Denmark, 4600

Sponsors and Collaborators

Region Zealand

Investigators

• Principal Investigator: Sara Kristensen, Doctor; Department of Surgery, Bariatric Clinic, Koge Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sara Kristensen, Doctor, Region Zealand
• ClinicalTrials.gov Identifier: NCT01595230
• Other Study ID Numbers: SJ-284
• First Posted: May 10, 2012
• Last Update Posted: April 1, 2020
• Last Verified: March 2020

Keywords provided by Sara Kristensen, Region Zealand:

Internal Hernias; Clips; Gastric Bypass; Avoid

Additional relevant MeSH terms:

Hernia; Hernia, Abdominal; Pathological Conditions, Anatomical