Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
the incidence of anastomotic stricture
the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram
three months
No
Qi L Chen
Study Chair
the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University
China: Ministry of Health
WCH20070901
NCT01139229
November 2007
September 2008
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