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Comparison of Laparoscopic Versus Open Gastrectomy for Advanced Gastric Cancer:A Prospective Randomized Trial

NCT01043835 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2012-06-05

No results posted yet for this study

Summary

The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.

Conditions

  • Stomach Neoplasm
  • Laparoscopy
  • Gastrectomy
  • Complications

Interventions

PROCEDURE

Laparoscopy-assisted gastrectomy

A 10-mm trocar for laparoscope was inserted below the umbilicus. Another 10-mm trocar was introduced in the left preaxillary line 2 cm below the costal margin as a major hand port，and a 5-mm trocar was placed at the contralateral site for traction. A 5-mm trocar was inserted in the left midclavicular line 2 cm above the umbilicus as an accessory port, and a 15-mm trocar also as an accessory port was placed at the contralateral site. The operator stood on the left side of the patient. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction. Dissected stomach and lymph node are collected through additional 5 cm incision at a median superior abdominal incision.

PROCEDURE

Open gastrectomy

Approximately 15\~20 cm length incision is made from falciform process to periumbilical area. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction for all cases.

Sponsors & Collaborators

  • Yan Shi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01043835 on ClinicalTrials.gov