NCT01139229

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Neoplasms
• Surgical Stomas

Interventions

Type	Name	Description
OTHER	hybrid everted esophagogastric anastomosis
OTHER	the conventional hand-sewn anastomosis
OTHER	a stapled anastomosis

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-11-01
• Completion: 2008-09-01
• First posted: 2010-06-08
• Last updated: 2010-06-08