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Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy (GCQOL02)

Primary Purpose

Gastric Tumor

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Tumor focused on measuring Gastric Malignant Tumor, Total Gastrectomy, Reconstruction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists.

    • Patients 20-75 years old
    • Normal organ function, able to tolerate surgery, no clear contraindication for surgery
    • No evidence of metastases of adjacent organs
    • be able to provide follow-up over 2 years
    • No specific treatment for gastric cancer before surgery
    • In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
    • The subjects were able to understand and comply with the trial protocol, and signed informed consent.

Exclusion Criteria:

  • • Synchronous or metachronous (less than five years) and with other malignancies.

    • Cirrhosis and portal hypertension
    • Associated with blood diseases
    • Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
    • Suffering from a serious neurological diseases or psychological diseases affecting the life

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction

Arm Description

Outcomes

Primary Outcome Measures

Change in QOL (Quality of Life)
From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires

Secondary Outcome Measures

Nutritional status of patients

Full Information

First Posted
September 28, 2012
Last Updated
October 15, 2012
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01697943
Brief Title
Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy
Acronym
GCQOL02
Official Title
A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Roux-En-Y Pouch Reconstruction and Conventional Roux-En-Y Reconstruction in Patients Undergoing Total Gastrectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to find out more about differences of the quality of life in patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction. To find a better reconstruction for patients who received total gastrectomy.
Detailed Description
Total gastrectomy has been indicated mainly for advanced gastric cancer located from the upper to middle third of the stomach or multiple gastric cancers.The most common method of creating a way for food is called a "Roux-en-Y", in which one part of the intestines is connected with the end of the esophagus (the swallowing tube) in the abdomen, and another connection is made between the intestines ' lower down. Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It often is associated with a limitation of postoperative quality of life (QOL). To improve postoperative nutritional status and QOL, surgeons have tried to establish ideal reconstruction after total gastrectomy and the optimum procedure for reconstruction has been discussed. This study will compare the postoperative quality of life (QOL) of gastric pouch reconstruction with the usual reconstruction to see if the pouch makes patients feel better.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Tumor
Keywords
Gastric Malignant Tumor, Total Gastrectomy, Reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
Primary Outcome Measure Information:
Title
Change in QOL (Quality of Life)
Description
From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires
Time Frame
5years
Secondary Outcome Measure Information:
Title
Nutritional status of patients
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed at other institutions but slides must be confirmed at SHCA, as is routine care at our institution) , and the patients be assessed must be carried out total gastrectomy by three specialists. Patients 20-75 years old Normal organ function, able to tolerate surgery, no clear contraindication for surgery No evidence of metastases of adjacent organs be able to provide follow-up over 2 years No specific treatment for gastric cancer before surgery In line with the Declaration of Helsinki and the requirements of the hospital ethics committee. The subjects were able to understand and comply with the trial protocol, and signed informed consent. Exclusion Criteria: • Synchronous or metachronous (less than five years) and with other malignancies. Cirrhosis and portal hypertension Associated with blood diseases Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism. Suffering from a serious neurological diseases or psychological diseases affecting the life
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya Nong Wang, MD,PhD
Phone
+86-21 64175590
Ext
1208
Email
huahuang@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Huang, MD,PhD
Phone
+86-21 64175590
Ext
1205
Email
huahuang@fudan.edu.cn
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Nong Wang, MD,PhD
Phone
+86-21 64175590
Ext
1208
Email
huahuang@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Hua Huang, MD,PhD
Phone
+86-21 64175590
Ext
1205
Email
huahuang@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Ya Nong Wang, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy

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