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Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer

Phase 3
Completed
Conditions
Gastric Cancer
Interventions
Procedure: Reconstruction after total gastrectomy
Registration Number
NCT00746161
Lead Sponsor
Wakayama Medical University
Brief Summary

The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method

Detailed Description

Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
Inclusion Criteria
  • Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
  • Age 80 years or younger
  • No distant metastasis
Exclusion Criteria
  • Carcinoma in the remnant stomach
  • Stage intravenous (IV)
  • History of laparotomy
  • History of serious heart disease
  • Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
  • Absence of informed consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Reconstruction after total gastrectomyRoux-en-Y
2Reconstruction after total gastrectomydouble tract reconstruction
Primary Outcome Measures
NameTimeMethod
The %body weight ratio12 months after operation
Secondary Outcome Measures
NameTimeMethod
preoperative complication, PNI and QOL scorewithin one month, and 3 and 12months after operation

Trial Locations

Locations (1)

Second Department of Surgery, Wakayama Medical University

🇯🇵

Wakayama, Japan

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