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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02694081
• Other study ID #: 130021
• Secondary ID: 714488468
• Status: Recruiting
• Phase: Phase 2
• First received: January 29, 2016
• Last updated: December 29, 2016
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: July 2016
• Source: Jilin University
• Contact: Dong Yang, postgraduate
• Phone: 18243052038
• Email: 714488468[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• 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.
• Billroth II 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.

Locations

Country	Name	City	State
China	the first hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the number of patients with the complication of gastroesophageal reflux disease(GERD)	all patients of this clinical trial will be investigated by Gastroesophageal reflux disease questionnaire(GerdQ),and all patients whose score is beyond 8 will be collected.	6 month after surgery	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes