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Roux-en-Y vs. Roux-en-Y+ Pouch for D2 Total Gastrectomy

NCT02110628 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2018-01-24

No results posted yet for this study

Summary

Gastric is one of the most prevalence digestive malignance tumors in China. Radical resection of primary tumors and combine with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. Nowadays, in order to improve the quality of life, controversies still exist to the reconstruction methods of total gastrectomy. Although roux-en-y anastomosis is the most common method adopted after total gastrectomy for it is an easily and safety method reconstruction method, but some problems still need us to solve, such as little food reserves, less food intake per meal and fast gastric emptying. These problems significantly affect the patients' quality of life after surgery. Roux-en-Y+Jejunal pouch anastomosis is newly born method can significant increase the volume to improve postoperative quality of life have been proven by some little sample size randomized control trail With the improvement of the gastric cancer surgery, this study proposed by prospective randomized controlled clinical trials aimed to comparing quality of life after traditional Roux-en-Y type and Roux-en-Y+ Jejunal pouch type anastomosis for radical total gastrectomy. Quality of life was evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ)-C30 and QLQ-STO22. Quality of life will conducted in the 3 months, 6 months, 9 months, 12 months, 24 months, 36 months after gastrectomy.

Conditions

  • Gastric Cancer
  • Roux-en-y Anastomosis Site
  • Gastric Anastomosis (Site)
  • Quality of Life
  • Complication

Interventions

PROCEDURE

Roux-en-Y anastomosis

Roux-en-Y anastomosis

PROCEDURE

Roux-en-Y+Pouch anastomosis

Roux-en-Y+Pouch anastomosis

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Jian-Kun Hu, M.D. · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-08-31
Completion
2022-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02110628 on ClinicalTrials.gov