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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03349398
• Other study ID #: 130000
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: June 2, 2020

Study information

• Verified date: April 2020
• Source: Jilin University
• Contact: Quan Wang, Professor
• Phone: 18844097668
• Email: 18844097668[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 2, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 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

Related Conditions & MeSH terms

• Gastric Cancer
• Roux-en-Y
• Stomach Neoplasms
• Uncut Roux-en-Y

Intervention

Procedure:
• Uncut Roux-en-Y reconstruction
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.
• Roux-en-Y reconstruction
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.

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Ch'ang-ch'un	JI Lin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the incidence of other complications after operation		one month after surgery
Secondary	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