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Internal Hernia After Laparoscopic Gastric Bypass

Internal Hernia After Laparoscopic Gastric Bypass

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01137201
Enrollment
2507
Registered
2010-06-04
Start date
2010-05-31
Completion date
2015-11-30
Last updated
2015-12-03

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

Conditions

The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.

Keywords

Small bowel obstruction, Laparoscopic gastric bypass, Internal Hernia, Mesenteric defect, Morbid obesity

Brief summary

To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.

Detailed description

When the patients who has undergone a Laparoscopic Gastric Bypass lose weight, the mesenteric defects that are inevitable to cause, gets bigger and can cause an internal hernia (IH). This study will observe whether it is better to close the defects or leave them open. The patients will be randomized into two groups. One, where the defects are closed with sutures and one where the defects are left alone. The primary endpoint of the study is the prevalence of surgery for obstruction. Information about this will be gathered through the national register for obesity surgery in Sweden, SOReg. Each arm in the study will include 1200 patients and the follow up period will be three years. Since the register mentioned above is an ongoing register, the results can be studied over a longer period if wanted. The national hospital registry will further improve the follow-up.

Interventions

PROCEDURESuturing of mesenteric defects

Sponsors

Region Örebro County
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent

Exclusion criteria

* Conversion to open surgery prior to the randomization * Patients not giving a written consent

Design outcomes

Primary

MeasureTime frame
Surgery for small bowel obstruction after a LGBP procedure.2 years

Secondary

MeasureTime frameDescription
Serious Complicationswithin 2 years after surgeryDefined as Clavien grade 3b or more

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026