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

Not Applicable

Completed

• Conditions: Esophageal Neoplasms; Surgical Stomas
• Interventions: Other: hybrid everted esophagogastric anastomosis; Other: the conventional hand-sewn anastomosis; Other: a stapled anastomosis

• Registration Number: NCT01139229
• Lead Sponsor: Sichuan University

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2007-11
• Study Completion: 2008-09
• Status Verified: 2010-03
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-07
• Last Update Submitted: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Posted: 2010-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HE group	hybrid everted esophagogastric anastomosis	-
HS group	the conventional hand-sewn anastomosis	-
SA group	a stapled anastomosis	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The grades of dysphagia	three months	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	three months	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	three months