Uncut Roux-en-Y vs Roux-en-Y

Study Overview
=================
Brief Summary
-----------------
Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer

Detailed Description
-----------------
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Roux-en-Y reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer. Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Roux-en-Y anastomosis preoperatively without distinct indications. All clinical data, operation data, perioperative complications and related physiological indexes after surgery will be compared.

Official Title
-----------------
Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer

Conditions
-----------------
Roux-en-Y, Uncut Roux-en-Y, Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Uncut Roux-en-Y reconstruction
* Procedure: Roux-en-Y reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of distal gastric cancer underwent laparoscopy-assisted distal gastrectomy Exclusion Criteria: have simultaneously other cancer have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases have upper gastrointestinal surgery can't bear the gastric tube the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the group of Roux-en-Y<br> | Procedure: Roux-en-Y reconstruction<br>* Roux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Roux-en-Y construction will be used in this group.<br>|
| Experimental: the group of Uncut Roux-en-Y<br> | Procedure: Uncut Roux-en-Y reconstruction<br>* Uncut Roux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of Roux stasis syndrome | the incidence of Roux stasis syndrome after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. So the incidence of both reconstructions should be compared. | 3 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of other complications after operation |  | one month after surgery | 
| the quility of life according to the RGB standards | the RGB standards in Terms of Gastritis, Bile Reflux, and Gastric Residue | 12 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uncut Roux-en-Y, Roux-en-Y