Clinical trial · Interventional
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.
NCT01697943CI-TRIAL-00008279GCQOL02unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Tumor | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
- interventionNames
- Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
Primary outcomes (1)
- measure
- Change in QOL (Quality of Life)
- timeFrame
- 5years
- description
- 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 (1)
- measure
- Nutritional status of patients
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.