Evaluation of Four Reconstructions After Total Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00677456
• Other study ID #: TDH00431
• Status: Recruiting
• Phase: Phase 1
• First received: May 12, 2008
• Last updated: May 12, 2008
• Start date: January 2008
• Est. completion date: January 2013

Study information

• Verified date: January 2008
• Source: Tang-Du Hospital
• Contact: Xian Li He, doctor
• Phone: 86-029-8477-7432
• Email: wanghe[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2013
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Cancer
• Nutrition
• Stomach Neoplasms

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Department of general surgery,Tangdu hospital	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Tang-Du Hospital	Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients should live for 6 months at least, and with acceptable life quality		6 months	Yes
Secondary	There are significant differences among life qualities of the four reconstructions		1 year	Yes