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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01697943
Recruitment Status : Unknown
Verified October 2012 by Yanong Wang, Fudan University.
Recruitment status was:  Recruiting
First Posted : October 2, 2012
Last Update Posted : October 16, 2012
Information provided by (Responsible Party):
Yanong Wang, Fudan University

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.

Condition or disease Intervention/treatment Phase
Gastric Tumor Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction

Primary Outcome Measures :
  1. Change in QOL (Quality of Life) [ Time Frame: 5years ]
    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 :
  1. Nutritional status of patients [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01697943

Contact: Ya Nong Wang, MD,PhD +86-21 64175590 ext 1208
Contact: Hua Huang, MD,PhD +86-21 64175590 ext 1205

China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ya Nong Wang, MD,PhD    +86-21 64175590 ext 1208   
Contact: Hua Huang, MD,PhD    +86-21 64175590 ext 1205   
Principal Investigator: Ya Nong Wang, MD,PhD         
Sponsors and Collaborators
Fudan University

Responsible Party: Yanong Wang, Director of Department of Abdominal Surgery, Fudan University Identifier: NCT01697943     History of Changes
Other Study ID Numbers: 2012-44-563
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Yanong Wang, Fudan University:
Gastric Malignant Tumor
Total Gastrectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases