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Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

Sponsor
Sichuan University (Other)
Overall Status
Completed
CT.gov ID
NCT01139229
Collaborator
(none)
144
Enrollment
3
Arms
10
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hybrid everted esophagogastric anastomosis
  • Other: the conventional hand-sewn anastomosis
  • Other: a stapled anastomosis
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: HE group

Other: hybrid everted esophagogastric anastomosis
Other Names:
  • no other names

    		•
    Other: HS group

    Other: the conventional hand-sewn anastomosis
    Other Names:
  • no other names

    		•
    Other: SA group

    Other: a stapled anastomosis
    Other Names:
  • no other names

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the incidence of anastomotic stricture [three months]

      the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram

    Secondary Outcome Measures

    1. The grades of dysphagia [three months]

      0:No dysphagia on solid diet dysphagia on solid diet dyspahgia on semi-solid diet dysphagia on fluid diet dysphagia with water swallowing

    2. the grades of acid regurgitation [three months]

      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

    3. the clinicopathological parameters in relation to postoperative complications [three months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sichuan University

    Investigators

    • Study Chair: Qi L Chen, the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01139229
    Other Study ID Numbers:
    • WCH20070901
    First Posted:
    Jun 8, 2010
    Last Update Posted:
    Jun 8, 2010
    Last Verified:
    Mar 1, 2010
    Keywords provided by , ,
    Esophagogastrostomy
    Circular everted anastomosis
    Side-side anastomosis
    Randomized clinical trial
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Jun 8, 2010