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

Gastric Tumor Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01697943
• Other study ID #: 2012-44-563
• Status: Recruiting
• Phase: Phase 3
• First received: September 28, 2012
• Last updated: October 15, 2012
• Start date: May 2012
• Est. completion date: May 2017

Study information

• Verified date: October 2012
• Source: Fudan University
• Contact: Ya Nong Wang, MD,PhD
• Phone: +86-21 64175590
• Email: huahuang[@]fudan.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Tumor
• Stomach Neoplasms

Intervention

Procedure:
• Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5years	No
Secondary	Nutritional status of patients		5 years	No