The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric

December 29, 2016 updated by: Aiping shi, Jilin University

The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction

The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.

Study Overview

Status

Unknown

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 Billroth II 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, from February 2016 to February 2017. 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 Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Uncut Roux-en-Y Reconstruction
Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.
Procedure: 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.
ACTIVE_COMPARATOR: Billroth II Reconstruction
Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.
Procedure: Billroth II 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 time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Time Frame: within 2 hours after surgery
The time of reconstruction operation will be recorded in the operating note by nurses in minutes.
within 2 hours after surgery
change of potential of hydrogen ( pH) in remnant stomach
Time Frame: 1-6 days after surgery
In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened
1-6 days after surgery
the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Time Frame: within 2 hours after surgery
During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.
within 2 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of patients with the complication of Residual food
Time Frame: 6 month after surgery
During the upper gastrointestinal radiography，if there is residual food,the meglumine diatrizoate will be separate and then write down the number.
6 month after surgery
the number of patients with the complication of Reflux esophagitis
Time Frame: 6 month after surgery
During the upper gastrointestinal radiography,if there is meglumine diatrizoate refluxing to esophagus,it will be observed and written down in number.
6 month after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of patients with the complication of gastroesophageal reflux disease(GERD)
Time Frame: 6 month after surgery
all patients of this clinical trial will be investigated by Gastroesophageal reflux disease questionnaire(GerdQ),and all patients whose score is beyond 8 will be collected.
6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jilin University

Investigators

  • Study Director: Quan Wang, professor, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (ESTIMATE)

February 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130021
  • 714488468 (OTHER: Department of Gastrointestinal and Anal Surgery)

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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