Internal Hernia After Laparoscopic Gastric Bypass
| Tracking Information | |||||
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| First Received Date ICMJE | June 2, 2010 | ||||
| Last Updated Date | January 17, 2013 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Surgery for small bowel obstruction after a LGBP procedure. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The prevalence of surgery for obstruction after a LGBP procedure. [ Time Frame: 3 years ] | ||||
| Change History | Complete list of historical versions of study NCT01137201 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Serious Complications [ Time Frame: within 2 years after surgery ] [ Designated as safety issue: Yes ] Defined as Clavien grade 3b or more |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Internal Hernia After Laparoscopic Gastric Bypass | ||||
| Official Title ICMJE | Internal Hernia After Laparoscopic Gastric Bypass | ||||
| Brief Summary | To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | The Prevalence of Surgery for Gastrointestinal Obstruction After a LGBP Procedure. | ||||
| Intervention ICMJE | Procedure: Suturing of mesenteric defects | ||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 2508 | ||||
| Estimated Completion Date | June 2014 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01137201 | ||||
| Other Study ID Numbers ICMJE | EPN 2009/415 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Erik Stenberg, MD, University Hospital Orebro | ||||
| Study Sponsor ICMJE | University Hospital Orebro | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Orebro | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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