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Sponsors and Collaborators: |
Tang-Du Hospital Fourth Military Medical University |
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Information provided by: | Tang-Du Hospital |
ClinicalTrials.gov Identifier: | NCT00677456 |
There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.
Condition | Intervention | Phase |
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Gastric Cancer Nutrition |
Procedure: R-Y reconstruction after total gastrectomy Procedure: P-Y reconstruction after total gastrectomy Procedure: Pouch reconstruction after total gastrectomy Procedure: P-I reconstruction after total gastrectomy |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy |
Estimated Enrollment: | 80 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients will receive R-Y reconstruction after total gastrectomy as intervention
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Procedure: R-Y reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
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2: Active Comparator
Patients will receive P-Y reconstruction after total gastrectomy as intervention
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Procedure: P-Y reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y.
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3: Active Comparator
Patients will receive Pouch reconstruction after total gastrectomy as intervention.
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Procedure: Pouch reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.
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4: Active Comparator
Patients will receive P-I reconstruction after total gastrectomy as intervention.
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Procedure: P-I reconstruction after total gastrectomy
Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I.
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Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xian Li He, doctor | 86-029-8477-7432 | wanghe@fmmu.edu.cn |
Contact: Guo Qiang Bao, doctor | 86-029-8477-7731 | guoqiangbao@163.com |
China, Shaanxi | |
Department of general surgery,Tangdu hospital | Recruiting |
Xi'an, Shaanxi, China, 710038 | |
Contact: GuoQiang Bao, doctor 86-029-8477-7731 guoqiangbao@163.com | |
Contact: JiKai Yin, doctor 86-029-8477-7732 yjkfmmuu@hotmail.com | |
Principal Investigator: XianLi He, doctor | |
Principal Investigator: GuoQiang Bao, doctor | |
Principal Investigator: JiKai Yin, doctor |
Principal Investigator: | XianLi He, doctor | Department of general surgery, Tangdu hospital of fourth military medical university |
Responsible Party: | Department of Gastrointestinal Surgery, Tang-Du Hospital ( He XianLi/director of department of Gastrointestinal Surgery, Tang-Du Hospital ) |
Study ID Numbers: | TDH00431 |
Study First Received: | May 12, 2008 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00677456 |
Health Authority: | China: Ministry of Health |
Gastric Cancer total gastrectomy reconstruction life quality |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Quality of Life Gastrointestinal Neoplasms Stomach cancer |
Neoplasms Neoplasms by Site |