Evaluation of Four Reconstructions After Total Gastrectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 12, 2008

Last Updated Date

May 12, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patients should live for 6 months at least, and with acceptable life quality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

There are significant differences among life qualities of the four reconstructions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Evaluation of Four Reconstructions After Total Gastrectomy

Official Title ^ICMJE

Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Gastric Cancer
Nutrition

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: Patients will receive R-Y reconstruction after total gastrectomy as intervention
Active Comparator: Patients will receive P-Y reconstruction after total gastrectomy as intervention
Active Comparator: Patients will receive Pouch reconstruction after total gastrectomy as intervention.
Active Comparator: Patients will receive P-I reconstruction after total gastrectomy as intervention.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00677456

Responsible Party

He XianLi/director of department of Gastrointestinal Surgery, Tang-Du Hospital, Department of Gastrointestinal Surgery, Tang-Du Hospital

Study ID Numbers ^ICMJE

TDH00431

Study Sponsor ^ICMJE

Tang-Du Hospital

Collaborators ^ICMJE

Fourth Military Medical University

Investigators ^ICMJE

Principal Investigator:

XianLi He, doctor

Department of general surgery, Tangdu hospital of fourth military medical university

Information Provided By

Tang-Du Hospital

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP