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.
20 Years
75 Years
Both
Gastric Tumor
Trial Information
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.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in QOL (Quality of Life)
Outcome 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
Outcome Time Frame:
5years
Safety Issue:
No
Authority:
China: Food and Drug Administration
Study ID:
2012-44-563
NCT ID:
NCT01697943
Start Date:
May 2012
Completion Date:
May 2017
Related Keywords:
- Gastric Tumor
- Gastric Malignant Tumor
- Total Gastrectomy
- Reconstruction
- Stomach Neoplasms
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