Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
Primary Purpose
Esophageal Neoplasms, Surgical Stomas
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hybrid everted esophagogastric anastomosis
the conventional hand-sewn anastomosis
a stapled anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms focused on measuring Esophagogastrostomy, Circular everted anastomosis, Side-side anastomosis, Randomized clinical trial
Eligibility Criteria
Inclusion Criteria:
- pathologically diagnosed esophageal neoplasms
- undergoing the Esophagogastrostomy
Exclusion Criteria:
- the patients with previous the upper gastrointestinal tract surgery
- the esophageal carcinoma patients with previous neoadjuvant chemotherapy
- the esophageal carcinoma complicated other esophagogastric diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
HE group
HS group
SA group
Arm Description
Outcomes
Primary Outcome Measures
the incidence of anastomotic stricture
the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram
Secondary Outcome Measures
The grades of dysphagia
0:No dysphagia on solid diet
dysphagia on solid diet
dyspahgia on semi-solid diet
dysphagia on fluid diet
dysphagia with water swallowing
the grades of acid regurgitation
0:no reflux on semi-supine position
postprandial reflux on semi-supine position
reflux with empty stomatch on semi-supine position
postprandial reflux on upright position
reflux with empty stomach on upright positino
the clinicopathological parameters in relation to postoperative complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01139229
Brief Title
Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
Official Title
Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sichuan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Surgical Stomas
Keywords
Esophagogastrostomy, Circular everted anastomosis, Side-side anastomosis, Randomized clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HE group
Arm Type
Other
Arm Title
HS group
Arm Type
Other
Arm Title
SA group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
hybrid everted esophagogastric anastomosis
Other Intervention Name(s)
no other names
Intervention Type
Other
Intervention Name(s)
the conventional hand-sewn anastomosis
Other Intervention Name(s)
no other names
Intervention Type
Other
Intervention Name(s)
a stapled anastomosis
Other Intervention Name(s)
no other names
Primary Outcome Measure Information:
Title
the incidence of anastomotic stricture
Description
the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram
Time Frame
three months
Secondary Outcome Measure Information:
Title
The grades of dysphagia
Description
0:No dysphagia on solid diet
dysphagia on solid diet
dyspahgia on semi-solid diet
dysphagia on fluid diet
dysphagia with water swallowing
Time Frame
three months
Title
the grades of acid regurgitation
Description
0:no reflux on semi-supine position
postprandial reflux on semi-supine position
reflux with empty stomatch on semi-supine position
postprandial reflux on upright position
reflux with empty stomach on upright positino
Time Frame
three months
Title
the clinicopathological parameters in relation to postoperative complications
Time Frame
three months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathologically diagnosed esophageal neoplasms
undergoing the Esophagogastrostomy
Exclusion Criteria:
the patients with previous the upper gastrointestinal tract surgery
the esophageal carcinoma patients with previous neoadjuvant chemotherapy
the esophageal carcinoma complicated other esophagogastric diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi L Chen
Organizational Affiliation
the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
9296510
Citation
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.
Results Reference
result
PubMed Identifier
16269373
Citation
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.
Results Reference
result
PubMed Identifier
16791967
Citation
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.
Results Reference
result
PubMed Identifier
18210181
Citation
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.
Results Reference
result
PubMed Identifier
10595609
Citation
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.
Results Reference
result
PubMed Identifier
23381675
Citation
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.
Results Reference
derived
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Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
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