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

Intervention / Treatment

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 Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Department of general surgery,Tangdu hospital
        • Contact:
        • Contact:
        • 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
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • P-I reconstruction

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

Tang-Du Hospital

Collaborators

Air Force Military Medical University, China

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

Keywords

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.

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