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The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications.
This randomized clinical trial compared a hybrid everted esophagogastric anastomosis with conventional hand-sewn or stapled esophagogastrostomy for prevention of anastomotic stricture. The patients were completely randomized to receive either a hybrid everted esophagogastric anastomosis (HE group), or the conventional hand-sewn (HS group), or a stapled (SA group) anastomosis, after the removal of esophageal tumor. The primary outcome measured the incidence of anastomotic stricture at 3 months after the operation (defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram), analyzed by intention-to-treat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HE group | Other |
| |
| HS group | Other |
| |
| SA group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hybrid everted esophagogastric anastomosis | Other |
|
| |
| the conventional hand-sewn anastomosis |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of anastomotic stricture | the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram | three months |
| Measure | Description | Time Frame |
|---|---|---|
| The grades of dysphagia | 0:No dysphagia on solid diet
| three months |
| the grades of acid regurgitation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi L Chen | the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9296510 | Result | Law S, Fok M, Chu KM, Wong J. Comparison of hand-sewn and stapled esophagogastric anastomosis after esophageal resection for cancer: a prospective randomized controlled trial. Ann Surg. 1997 Aug;226(2):169-73. doi: 10.1097/00000658-199708000-00008. | |
| 16269373 | Result | Behzadi A, Nichols FC, Cassivi SD, Deschamps C, Allen MS, Pairolero PC. Esophagogastrectomy: the influence of stapled versus hand-sewn anastomosis on outcome. J Gastrointest Surg. 2005 Nov;9(8):1031-40; discussion 1040-2. doi: 10.1016/j.gassur.2005.06.025. |
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| Other |
|
|
| a stapled anastomosis | Other |
|
|
0:no reflux on semi-supine position
| three months |
| the clinicopathological parameters in relation to postoperative complications | three months |
| 16791967 | Result | Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005 Jan;1(1):40-5. doi: 10.1016/j.explore.2004.11.001. |
| 18210181 | Result | Zhu ZJ, Zhao YF, Chen LQ, Hu Y, Liu LX, Wang Y, Kou YL. Clinical application of layered anastomosis during esophagogastrostomy. World J Surg. 2008 Apr;32(4):583-8. doi: 10.1007/s00268-007-9396-5. |
| 10595609 | Result | Laterza E, de' Manzoni G, Veraldi GF, Guglielmi A, Tedesco P, Cordiano C. Manual compared with mechanical cervical oesophagogastric anastomosis: a randomised trial. Eur J Surg. 1999 Nov;165(11):1051-4. doi: 10.1080/110241599750007883. |
| 23381675 | Derived | Wang WP, Gao Q, Wang KN, Shi H, Chen LQ. A prospective randomized controlled trial of semi-mechanical versus hand-sewn or circular stapled esophagogastrostomy for prevention of anastomotic stricture. World J Surg. 2013 May;37(5):1043-50. doi: 10.1007/s00268-013-1932-x. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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