GCQOL02A 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.
Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fudan University Shanghai Cancer Center
Shanghai, ChinaOpen Fudan University Shanghai Cancer Center in Google Maps