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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Neoplasms, Surgical Stomas

Intervention / Treatment
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* Other: hybrid everted esophagogastric anastomosis
* Other: the conventional hand-sewn anastomosis
* Other: a stapled anastomosis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HE group<br> | Other: hybrid everted esophagogastric anastomosis<br> <br> * Other names: no other names;|
| Other: HS group<br> | Other: the conventional hand-sewn anastomosis<br> <br> * Other names: no other names;|
| Other: SA group<br> | Other: a stapled anastomosis<br> <br> * Other names: no other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of anastomotic stricture | the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | three months | 
| 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 | three months | 
| the clinicopathological parameters in relation to postoperative complications |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophagogastrostomy, Circular everted anastomosis, Side-side anastomosis, Randomized clinical trial