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

Not Applicable

• Conditions: Roux-en-Y; Uncut Roux-en-Y; Gastric Cancer
• Interventions: Procedure: Roux-en-Y reconstruction; Procedure: Uncut Roux-en-Y reconstruction

• Registration Number: NCT03349398
• Lead Sponsor: Jilin University

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.

Study Timeline

• Study Start: 2017-11-10
• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
the group of Roux-en-Y	Roux-en-Y reconstruction	-
the group of Uncut Roux-en-Y	Uncut Roux-en-Y reconstruction	-

Primary Outcome Measures

Name	Time	Method
the incidence of Roux stasis syndrome	3 month after surgery	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.

Secondary Outcome Measures

Name	Time	Method
the quility of life according to the RGB standards	12 month after surgery	the RGB standards in Terms of Gastritis, Bile Reflux, and Gastric Residue
the incidence of other complications after operation	one month after surgery

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Ch'ang-ch'un, JI Lin, China