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Evaluation of Four Reconstructions After Total Gastrectomy

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ClinicalTrials.gov Identifier: NCT00677456
Recruitment Status : Unknown
Verified January 2008 by Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : May 14, 2008
Last Update Posted : May 14, 2008
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by:
Tang-Du Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
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 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy
Study Start Date : January 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : January 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Patients will receive R-Y reconstruction after total gastrectomy as intervention
 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.
Other Name: R-Y reconstruction
Active Comparator: 2
Patients will receive P-Y reconstruction after total gastrectomy as intervention
 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.
Other Name: P-Y reconstruction
Active Comparator: 3
Patients will receive Pouch reconstruction after total gastrectomy as intervention.
 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.
Other Name: Pouch reconstruction
Active Comparator: 4
Patients will receive P-I reconstruction after total gastrectomy as intervention.
 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.
Other Name: P-I reconstruction


Outcome Measures
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Primary Outcome Measures :
  1. Patients should live for 6 months at least, and with acceptable life quality [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. There are significant differences among life qualities of the four reconstructions [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.

Exclusion Criteria:

  • death or other reason which cause information discontinue
Contacts and Locations
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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): NCT00677456


Contacts
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

Locations
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         
Sponsors and Collaborators
Tang-Du Hospital
Fourth Military Medical University
Investigators
Principal Investigator: XianLi He, doctor Department of general surgery, Tangdu hospital of fourth military medical university
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: He XianLi/director of department of Gastrointestinal Surgery, Tang-Du Hospital, Department of Gastrointestinal Surgery, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT00677456     History of Changes
Other Study ID Numbers: TDH00431
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: January 2008

Keywords provided by Tang-Du Hospital:
Gastric Cancer
total gastrectomy
reconstruction
life quality

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases