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NCT Number: NCT01139229

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

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.

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Key information

Conditions

Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Surgical Stomas

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hybrid everted esophagogastric anastomosis

Other

Other names: no other names

the conventional hand-sewn anastomosis

Other

Other names: no other names

a stapled anastomosis

Other

Other names: no other names

Primary outcomes

  1. the incidence of anastomotic stricture

    Time frame: three months

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

Secondary outcomes

  1. The grades of dysphagia

    Time frame: 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

    Time frame: 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

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jun 8, 2010
Registry last updated
Jun 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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