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

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ClinicalTrials.gov Identifier: NCT03349398
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Dong Yang, Jilin University

Study Description
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Brief Summary:
Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer

Condition or disease Intervention/treatment Phase
Uncut Roux-en-Y Roux-en-Y Gastric Cancer Procedure: Uncut Roux-en-Y reconstruction Procedure: Roux-en-Y reconstruction Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: the group of Roux-en-Y Procedure: Roux-en-Y reconstruction
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 Procedure: Uncut Roux-en-Y reconstruction
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. the incidence of other complications after operation [ Time Frame: one month after surgery ]
  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349398


Contacts
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Contact: Quan Wang, Professor 18844097668 18844097668@163.com
Contact: Dong Yang, Master 714488468@qq.com

Locations
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China, JI Lin
the First Hospital of Jilin University Recruiting
Ch'ang-ch'un, JI Lin, China, 130021
Contact: Quan Wang, Professor       18844097668@163.com   
Sponsors and Collaborators
Jilin University
Investigators
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Study Director: Quan Wang, Doctor The First Hospital of Jilin University
More Information
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Responsible Party: Dong Yang, Assisted Investigator, Jilin University
ClinicalTrials.gov Identifier: NCT03349398    
Other Study ID Numbers: 130000
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong Yang, Jilin University:
Uncut Roux-en-Y
Roux-en-Y
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases