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


N/A
N/A
N/A
Not Enrolling
Both
Esophageal Neoplasms, Surgical Stomas

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the incidence of anastomotic stricture

Outcome Description:

the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram

Outcome Time Frame:

three months

Safety Issue:

No

Principal Investigator

Qi L Chen

Investigator Role:

Study Chair

Investigator Affiliation:

the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University

Authority:

China: Ministry of Health

Study ID:

WCH20070901

NCT ID:

NCT01139229

Start Date:

November 2007

Completion Date:

September 2008

Related Keywords:

  • Esophageal Neoplasms
  • Surgical Stomas
  • Esophagogastrostomy
  • Circular everted anastomosis
  • Side-side anastomosis
  • Randomized clinical trial
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Constriction, Pathologic

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