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OpenTrials
Completed

NCT Number: NCT01137201

Internal Hernia After Laparoscopic Gastric Bypass

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

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Key information

Conditions

The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure. Body Weight Hernia Internal Hernia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Örebro University Hospital

Örebro, Örebro County, 701 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suturing of mesenteric defects

Procedure

Primary outcomes

  1. Surgery for small bowel obstruction after a LGBP procedure.

    Time frame: 2 years

Secondary outcomes

  1. Serious Complications

    Time frame: within 2 years after surgery

    Defined as Clavien grade 3b or more

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Jun 4, 2010
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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