Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy
Conditions
Gastric Tumor
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric Malignant Tumor, Total Gastrectomy, Reconstruction
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
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
Location
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
Status: Recruiting
Contact: Ya Nong Wang, MD,PhD - +86-21 64175590 - huahuang@fudan.edu.cn
Start Date
May 2012
Completion Date
May 2017
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page