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.
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Fudan University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Change in QOL (Quality of Life)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
Intervention: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Nutritional status of patients(5 years)
Investigators
Yanong Wang
Director of Department of Abdominal Surgery
Fudan University