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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inertervention group_Clips to avoid internal herniation | Experimental | LRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation. |
|
| Control group | No Intervention | conventional LRYGB without closure of the mesenteric defects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closing the mesenteric defects with clips during opration | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| To avoid the risk of Internal Hernias in patient with a Gastric bypass | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score (VAS) | 5 years | |
| Operative time consumption, the amount of clips, trocar and sutures used | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 30 days complication | 30 days complications:
| 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Kristensen, Doctor | Department of Surgery, Bariatric Clinic, Koge Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery;Bariatric Clinic, Køge Hospital | Køge | Sealand | 4600 | Denmark | ||
| Bariatric clinic, Department of Surgery, Køge hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33711136 | Derived | Kristensen SD, Gormsen J, Naver L, Helgstrand F, Floyd AK. Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery. Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055. | |
| 24947625 | Derived | Kristensen SD, Naver L, Jess P, Floyd AK. Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia. Dan Med J. 2014 Jun;61(6):A4854. |
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| ID | Term |
|---|---|
| D000082122 | Internal Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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|
|
| Køge |
| 4600 |
| Denmark |
| D000073319 |
| Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |