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lack of follow up
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Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.
This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no ring | Sham Comparator | Patients at this group will have RING REMOVED AT THE END OF SURGERY. |
|
| RYGBP-Ring | Active Comparator | Open Roux-en-Y gastric bypass with a silastic ring which is performed with linear cut stapler 100 mm and a biliopancreatic limb of 60 cm long and a alimentary limb of 100 cm long. All patients will have a 6.5 cm silastic ring located at the middle of the pouch above of the gastroenteroanastomosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Comparator: no ring | Procedure | Open roux-en-Y gastric bypass not banded |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of gastroesophageal reflux disease | Patients are intra-operatively selected to receive or not a silastic ring following a open gastric bypass. These patients will be evaluated for GERD with upper endoscopy, 24h ph-monitoring, validated questionnaires which will be performed at 6 month, 1 and 2 years. | march 2010 to march 2014 |
| Measure | Description | Time Frame |
|---|---|---|
| The role of the ring in open GBP in terms of weight loss | It will be possible to evaluate the weight loss among the groups: 1) with ring and, 2) without a ring | march 2010 to march 2014 |
| The impact of the ring on food tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Navarini, M.D. | Clinica Gastrobese | Study Chair |
| Carlos AS Madalosso, M.D. | Clinica Gastrobese | Principal Investigator |
| Iran Moraes Jr, M.D. | Clinica Gastrobese | Study Chair |
| Fabio R Barao, Admn | Protocol control | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Gastrobese | Passo Fundo | Rio Grande do Sul | 99010112 | Brazil | ||
| Gastrobese Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20010088 | Result | Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D005764 | Gastroesophageal Reflux |
| D014839 | Vomiting |
| D009765 | Obesity |
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| RYGBP-RING |
| Procedure |
Vertical Roux-en-Y banded gastric bypass |
|
To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.
| March 2010 to March 2014 |
| Passo Fundo |
| Rio Grande do Sul |
| 99020000 |
| Brazil |
| Hospital Sao Vicente de Paulo | Passo Fundo | Rio Grande do Sul | 99020000 | Brazil |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D005759 | Gastroenteritis |