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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
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 3, 2010
    Last Updated
    June 7, 2010
    Sponsor
    Sichuan University
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    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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