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

This study has been completed.
Sponsor:
Information provided by:
Sichuan University
ClinicalTrials.gov Identifier:
NCT01139229
First received: June 3, 2010
Last updated: June 7, 2010
Last verified: March 2010
  Purpose

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 Intervention
Esophageal Neoplasms
Surgical Stomas
Other: hybrid everted esophagogastric anastomosis
Other: the conventional hand-sewn anastomosis
Other: a stapled anastomosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

Resource links provided by NLM:


Further study details as provided by Sichuan University:

Primary Outcome Measures:
  • the incidence of anastomotic stricture [ Time Frame: three months ] [ Designated as safety issue: No ]
    the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram


Secondary Outcome Measures:
  • The grades of dysphagia [ Time Frame: three months ] [ Designated as safety issue: No ]

    0:No dysphagia on solid diet

    1. dysphagia on solid diet
    2. dyspahgia on semi-solid diet
    3. dysphagia on fluid diet
    4. dysphagia with water swallowing

  • the grades of acid regurgitation [ Time Frame: three months ] [ Designated as safety issue: No ]

    0:no reflux on semi-supine position

    1. postprandial reflux on semi-supine position
    2. reflux with empty stomatch on semi-supine position
    3. postprandial reflux on upright position
    4. reflux with empty stomach on upright positino

  • the clinicopathological parameters in relation to postoperative complications [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HE group Other: hybrid everted esophagogastric anastomosis
Other Name: no other names
HS group Other: the conventional hand-sewn anastomosis
Other Name: no other names
SA group Other: a stapled anastomosis
Other Name: no other names

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01139229

Sponsors and Collaborators
Sichuan University
Investigators
Study Chair: Qi L Chen the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Long-Qi Chen, Professor, Department of Thoracic and Cardiovascular Surgery, West China Hospital of Sichuan University
ClinicalTrials.gov Identifier: NCT01139229     History of Changes
Other Study ID Numbers: WCH20070901
Study First Received: June 3, 2010
Last Updated: June 7, 2010
Health Authority: China: Ministry of Health

Keywords provided by Sichuan University:
Esophagogastrostomy
Circular everted anastomosis
Side-side anastomosis
Randomized clinical trial

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014