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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Evaluation of serum gastrin levels and their effect on marginal ulcer formation.
Prospective, randomized, interventional trial. Participants will be randomized to one of two surgical techniques, either with transection of the vagal nerves, or without. Outcomes including compare marginal ulcer rates will be compared using serum gastrin levels before and after surgery and gastric pH during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Bypass with Transection of Vagal Nerves | Active Comparator |
| |
| Gastric Bypass Without Transection of Vagal Nerves | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass with transection of vagal nerves | Procedure | Vagal nerve interruption above the level of the stomach is a known treatment for complicated peptic ulcer disease. It is not commonly performed during routine gastric bypass. The vagi are, however, interrupted part-way down the stomach to create the gastric pouch. This is the pars flaccida technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Marginal Ulcer | Number of participants with a change in serum gastrin levels compared pre- and post-surgery. | From surgical intervention to five years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sugong Chen, MD | Sanford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Health | Fargo | North Dakota | 58102 | United States |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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| Gastric bypass without transection of vagal nerves | Procedure | Dissection between the neurovascular bundle and the stomach, spareing the vagus nerves. This is the perigastric technique. |
|
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |