Uncut Roux-en-Y vs Roux-en-Y
Primary Purpose
Uncut Roux-en-Y, Roux-en-Y, Gastric Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Uncut Roux-en-Y reconstruction
Roux-en-Y reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Uncut Roux-en-Y focused on measuring Uncut Roux-en-Y, Roux-en-Y
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
Sites / Locations
- the First Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
the group of Roux-en-Y
the group of Uncut Roux-en-Y
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
the incidence of other complications after operation
the quility of life according to the RGB standards
the RGB standards in Terms of Gastritis, Bile Reflux, and Gastric Residue
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03349398
Brief Title
Uncut Roux-en-Y vs Roux-en-Y
Official Title
Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncut Roux-en-Y, Roux-en-Y, Gastric Cancer
Keywords
Uncut Roux-en-Y, Roux-en-Y
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the group of Roux-en-Y
Arm Type
Active Comparator
Arm Title
the group of Uncut Roux-en-Y
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Uncut Roux-en-Y reconstruction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of Roux stasis syndrome
Description
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.
Time Frame
3 month after surgery
Secondary Outcome Measure Information:
Title
the incidence of other complications after operation
Time Frame
one month after surgery
Title
the quility of life according to the RGB standards
Description
the RGB standards in Terms of Gastritis, Bile Reflux, and Gastric Residue
Time Frame
12 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Wang, Professor
Phone
18844097668
Email
18844097668@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Yang, Master
Email
714488468@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Wang, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
Facility Information:
Facility Name
the First Hospital of Jilin University
City
Ch'ang-ch'un
State/Province
JI Lin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Wang, Professor
Email
18844097668@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Uncut Roux-en-Y vs Roux-en-Y
We'll reach out to this number within 24 hrs