search
Back to results

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
Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 12, 2017
Last Updated
April 15, 2020
Sponsor
Jilin University
search

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