Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy (GCQOL02)
Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
|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 ]
|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)|
|Experimental: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction||Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697943
|Contact: Ya Nong Wang, MD,PhD||+86-21 64175590 ext firstname.lastname@example.org|
|Contact: Hua Huang, MD,PhD||+86-21 64175590 ext email@example.com|
|Fudan University Shanghai Cancer Center||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Ya Nong Wang, MD,PhD +86-21 64175590 ext 1208 firstname.lastname@example.org|
|Contact: Hua Huang, MD,PhD +86-21 64175590 ext 1205 email@example.com|
|Principal Investigator: Ya Nong Wang, MD,PhD|