Evaluation of Four Reconstructions After Total Gastrectomy
May 12, 2008 updated by: Tang-Du Hospital
Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710038
- Recruiting
- Department of general surgery,Tangdu hospital
-
Contact:
- GuoQiang Bao, doctor
- Phone Number: 86-029-8477-7731
- Email: guoqiangbao@163.com
-
Contact:
- JiKai Yin, doctor
- Phone Number: 86-029-8477-7732
- Email: yjkfmmuu@hotmail.com
-
Principal Investigator:
- XianLi He, doctor
-
Principal Investigator:
- GuoQiang Bao, doctor
-
Principal Investigator:
- JiKai Yin, doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Patients will receive R-Y reconstruction after total gastrectomy as intervention
|
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 Names:
|
|
Active Comparator: 2
Patients will receive P-Y reconstruction after total gastrectomy as intervention
|
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 Names:
|
|
Active Comparator: 3
Patients will receive Pouch reconstruction after total gastrectomy as intervention.
|
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 Names:
|
|
Active Comparator: 4
Patients will receive P-I reconstruction after total gastrectomy as intervention.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patients should live for 6 months at least, and with acceptable life quality
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
There are significant differences among life qualities of the four reconstructions
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: XianLi He, doctor, Department of general surgery, Tangdu hospital of fourth military medical university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Anticipated)
February 1, 2010
Study Completion (Anticipated)
January 1, 2013
Study Registration Dates
First Submitted
May 12, 2008
First Submitted That Met QC Criteria
May 12, 2008
First Posted (Estimate)
May 14, 2008
Study Record Updates
Last Update Posted (Estimate)
May 14, 2008
Last Update Submitted That Met QC Criteria
May 12, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDH00431
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.