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To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenteric defects sutured | Experimental | Closure of the mesenteric defects using running, non-absorbable suture |
|
| Mesenteric defects not sutured | No Intervention | Non-closure of the mesenteric defects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suturing of mesenteric defects | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgery for small bowel obstruction after a LGBP procedure. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Complications | Defined as Clavien grade 3b or more | within 2 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingmar Näslund, MD, PhD | Scandinavian Obesity Surgery Registry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Örebro University Hospital | Örebro | Örebro County | 701 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37163240 | Derived | Stenberg E, Ottosson J, Magnuson A, Szabo E, Wallen S, Naslund E, Thorell A, Naslund I. Long-term Safety and Efficacy of Closure of Mesenteric Defects in Laparoscopic Gastric Bypass Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):709-717. doi: 10.1001/jamasurg.2023.1042. | |
| 28676957 | Derived |
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| ID | Term |
|---|---|
| D000082122 | Internal Hernia |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009765 | Obesity |
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| Stenberg E, Szabo E, Ottosson J, Thorell A, Naslund I. Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial. Obes Surg. 2018 Jan;28(1):31-36. doi: 10.1007/s11695-017-2798-z. |
| 26895675 | Derived | Stenberg E, Szabo E, Agren G, Ottosson J, Marsk R, Lonroth H, Boman L, Magnuson A, Thorell A, Naslund I. Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial. Lancet. 2016 Apr 2;387(10026):1397-1404. doi: 10.1016/S0140-6736(15)01126-5. Epub 2016 Feb 16. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |