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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01697943

Acronym

GCQOL02

Enrollment

140

Registered

2012-10-02

Start date

2012-05-31

Completion date

2017-05-31

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Tumor

Keywords

Gastric Malignant Tumor, Total Gastrectomy, Reconstruction

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.

Interventions

PROCEDURERoux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in QOL (Quality of Life)	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

Measure	Time frame
Nutritional status of patients	5 years

Countries

China

Contacts

Primary ContactYa Nong Wang, MD,PhD

huahuang@fudan.edu.cn+86-21 64175590

Backup ContactHua Huang, MD,PhD