Uncut Roux-en-Y vs Roux-en-Y
1 other identifier
interventional
84
1 country
1
Brief Summary
Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2017
CompletedFirst Submitted
Initial submission to the registry
November 12, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2020
CompletedApril 16, 2020
April 1, 2020
2.6 years
November 12, 2017
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
the incidence of other complications after operation
one month after surgery
the quility of life according to the RGB standards
12 month after surgery
Study Arms (2)
the group of Roux-en-Y
ACTIVE COMPARATORthe group of Uncut Roux-en-Y
EXPERIMENTALInterventions
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 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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of distal gastric cancer
- underwent laparoscopy-assisted distal gastrectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jilin Universitylead
Study Sites (1)
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, 130021, China
Related Publications (1)
Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
PMID: 38421211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Quan Wang, Doctor
The First Hospital of Jilin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisted Investigator
Study Record Dates
First Submitted
November 12, 2017
First Posted
November 21, 2017
Study Start
November 10, 2017
Primary Completion
June 1, 2020
Study Completion
June 2, 2020
Last Updated
April 16, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share