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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|ClinicalTrials.gov Identifier: NCT01697943|
Recruitment Status : Unknown
Verified October 2012 by Yanong Wang, Fudan University.
Recruitment status was: Recruiting
First Posted : October 2, 2012
Last Update Posted : October 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gastric Tumor||Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2017|
|Experimental: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction||Procedure: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction|
- Change in QOL (Quality of Life) [ Time Frame: 5years ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|