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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01595230

Enrollment

405

Registered

2012-05-10

Start date

2012-05-31

Completion date

2023-01-31

Last updated

2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internal Hernias

Keywords

Internal Hernias, Clips, Gastric Bypass, Avoid

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

Interventions

PROCEDUREClosing 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To avoid the risk of Internal Hernias in patient with a Gastric bypass	5 year

Secondary

Measure	Time frame
Postoperative pain score (VAS)	5 years
Operative time consumption, the amount of clips, trocar and sutures used	3 years

Other

Measure	Time frame	Description
30 days complication	3 years	30 days complications: * Anastomotic leak * Bleeding (Hb) * Blood transfusions (MAF) * Ileus due to kinking, blowout of the bypassed stomach * Intraperitoneal abscesses.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026