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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Yanong Wang, Fudan University
ClinicalTrials.gov Identifier:
NCT01697943
First received: September 28, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Gastric Tumor
Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Change in QOL (Quality of Life) [ Time Frame: 5years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697943

Contacts
Contact: Ya Nong Wang, MD,PhD +86-21 64175590 ext 1208 huahuang@fudan.edu.cn
Contact: Hua Huang, MD,PhD +86-21 64175590 ext 1205 huahuang@fudan.edu.cn

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ya Nong Wang, MD,PhD    +86-21 64175590 ext 1208    huahuang@fudan.edu.cn   
Contact: Hua Huang, MD,PhD    +86-21 64175590 ext 1205    huahuang@fudan.edu.cn   
Principal Investigator: Ya Nong Wang, MD,PhD         
Sponsors and Collaborators
Fudan University
  More Information

No publications provided

Responsible Party: Yanong Wang, Director of Department of Abdominal Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT01697943     History of Changes
Other Study ID Numbers: 2012-44-563
Study First Received: September 28, 2012
Last Updated: October 15, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Gastric Malignant Tumor
Total Gastrectomy
Reconstruction

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

ClinicalTrials.gov processed this record on August 28, 2014