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

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Fudan University

Status and phase

Unknown
Phase 3

Conditions

Gastric Tumor

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01697943
2012-44-563

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

140 participants in 1 patient group

Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
Experimental group
Treatment:
Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction

Trial contacts and locations

0

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Central trial contact

Ya Nong Wang, MD,PhD; Hua Huang, MD,PhD

Data sourced from clinicaltrials.gov

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