Evaluation of Four Reconstructions After Total Gastrectomy

Study Overview
=================
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.

Official Title
-----------------
Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy

Conditions
-----------------
Gastric Cancer, Nutrition

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will receive R-Y reconstruction after total gastrectomy as intervention | Procedure: R-Y reconstruction after total gastrectomy<br>* 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.<br>* Other names: R-Y reconstruction;|
| Active Comparator: 2<br>Patients will receive P-Y reconstruction after total gastrectomy as intervention | Procedure: P-Y reconstruction after total gastrectomy<br>* 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.<br>* Other names: P-Y reconstruction;|
| Active Comparator: 3<br>Patients will receive Pouch reconstruction after total gastrectomy as intervention. | Procedure: Pouch reconstruction after total gastrectomy<br>* 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.<br>* Other names: Pouch reconstruction;|
| Active Comparator: 4<br>Patients will receive P-I reconstruction after total gastrectomy as intervention. | Procedure: P-I reconstruction after total gastrectomy<br>* 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.<br>* Other names: P-I reconstruction;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients should live for 6 months at least, and with acceptable life quality |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There are significant differences among life qualities of the four reconstructions |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, total gastrectomy, reconstruction, life quality