The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric

Study Overview
=================
Brief Summary
-----------------
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.

Detailed Description
-----------------
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Billroth II 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, from February 2016 to February 2017. 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 Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.

Official Title
-----------------
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Uncut Roux-en-Y Reconstruction
* Procedure: Billroth II 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
-----------------
Maximum Age: 85 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uncut Roux-en-Y Reconstruction<br>Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer. | Procedure: Uncut Roux-en-Y Reconstruction<br>* 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>|
| Active Comparator: Billroth II Reconstruction<br>Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer. | Procedure: Billroth II Reconstruction<br>* 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 time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction | The time of reconstruction operation will be recorded in the operating note by nurses in minutes. | within 2 hours after surgery | 
| change of potential of hydrogen ( pH) in remnant stomach | In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened | 1-6 days after surgery | 
| the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction | During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters. | within 2 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients with the complication of Residual food | During the upper gastrointestinal radiography，if there is residual food,the meglumine diatrizoate will be separate and then write down the number. | 6 month after surgery | 
| the number of patients with the complication of Reflux esophagitis | During the upper gastrointestinal radiography,if there is meglumine diatrizoate refluxing to esophagus,it will be observed and written down in number. | 6 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reflux, residue, Gastric stasis, Emptying time