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| Name | Class |
|---|---|
| Hospital State Public | UNKNOWN |
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Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | dividing short gastric vessels |
|
| 2 | Active Comparator | non-dividing short gastric vessels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lap Nissen fundoplication with division of short gastric vessels | Procedure | Dividing short gastric vessels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels. | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term clinical and endoscopic outcome | 8-10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Carlos DelGrande, MD | Federal University of São Paulo | Study Director |
| Michelle L DeOliveira, MD | Federal University of São Paulo | Study Chair |
| Francisco Farah, MD | Federal University of São Paulo | Principal Investigator |
| Renato Lupinacci, MD | Hospital State Public Server São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo - UNIFESP | São Paulo | São Paulo | 04023-071 | Brazil | ||
| State Public Server of São Paulo Hospital (HSPE) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18156921 | Background | Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG. Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg. 2008 Jan;247(1):38-42. doi: 10.1097/SLA.0b013e31814a693e. | |
| 11807353 | Background | O'Boyle CJ, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Division of short gastric vessels at laparoscopic nissen fundoplication: a prospective double-blind randomized trial with 5-year follow-up. Ann Surg. 2002 Feb;235(2):165-70. doi: 10.1097/00000658-200202000-00001. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Laparoscopic Nissen fundoplication without division of short gastric vessels | Procedure | non-dividing short gastric vessels |
|
|
| São Paulo |
| São Paulo |
| 04025-000 |
| Brazil |
| 15545560 | Background | Watson DI, Jamieson GG, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford G, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society for Diseases of the Esophagus--Australasian Section. Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004 Nov;139(11):1160-7. doi: 10.1001/archsurg.139.11.1160. |
| 18235928 | Result | Farah JF, Grande JC, Goldenberg A, Martinez JC, Lupinacci RA, Matone J. Randomized trial of total fundoplication and fundal mobilization with or without division of short gastric vessels: a short-term clinical evaluation. Acta Cir Bras. 2007 Nov-Dec;22(6):422-9. doi: 10.1590/s0102-86502007000600002. |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D018662 | Fundoplication |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
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