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

Sichuan University

Status: Completed

Conditions: Surgical Stomas; Esophageal Neoplasms

Treatments: Other: the conventional hand-sewn anastomosis; Other: a stapled anastomosis; Other: hybrid everted esophagogastric anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01139229

WCH20070901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 3 patient groups

HE group

Other group

Treatment:

Other: hybrid everted esophagogastric anastomosis

HS group

Other group

Treatment:

Other: the conventional hand-sewn anastomosis

SA group

Other group

Treatment:

Other: a stapled anastomosis