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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Tumor |
Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
- Change in QOL (Quality of Life) [ Time Frame: 5years ] [ Designated as safety issue: No ]From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires
- Nutritional status of patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction | Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Ya Nong Wang, MD,PhD | +86-21 64175590 ext 1208 | huahuang@fudan.edu.cn |
| Contact: Hua Huang, MD,PhD | +86-21 64175590 ext 1205 | huahuang@fudan.edu.cn |
| China, Shanghai | |
| Fudan University Shanghai Cancer Center | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Ya Nong Wang, MD,PhD +86-21 64175590 ext 1208 huahuang@fudan.edu.cn | |
| Contact: Hua Huang, MD,PhD +86-21 64175590 ext 1205 huahuang@fudan.edu.cn | |
| Principal Investigator: Ya Nong Wang, MD,PhD | |
More Information
No publications provided
| Responsible Party: | Yanong Wang, Director of Department of Abdominal Surgery, Fudan University |
| ClinicalTrials.gov Identifier: | NCT01697943 History of Changes |
| Other Study ID Numbers: | 2012-44-563 |
| Study First Received: | September 28, 2012 |
| Last Updated: | October 15, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Fudan University:
|
Gastric Malignant Tumor Total Gastrectomy Reconstruction |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 22, 2013