Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy
GCQOL02
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.
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2012
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedOctober 16, 2012
October 1, 2012
3 years
September 28, 2012
October 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in QOL (Quality of Life)
From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires
5years
Secondary Outcomes (1)
Nutritional status of patients
5 years
Study Arms (1)
Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Abdominal Surgery
Study Record Dates
First Submitted
September 28, 2012
First Posted
October 2, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2017
Last Updated
October 16, 2012
Record last verified: 2012-10