- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03349398
Uncut Roux-en-Y vs Roux-en-Y
Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
JI Lin
-
Ch'ang-ch'un, JI Lin, China, 130021
- Recruiting
- The First Hospital of Jilin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: the group of Roux-en-Y
|
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.
|
Experimental: the group of Uncut Roux-en-Y
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of Roux stasis syndrome
Time Frame: 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.
|
3 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of other complications after operation
Time Frame: one month after surgery
|
one month after surgery
|
|
the quility of life according to the RGB standards
Time Frame: 12 month after surgery
|
the RGB standards in Terms of Gastritis, Bile Reflux, and Gastric Residue
|
12 month after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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