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

NCT ID: NCT02694081

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Uncut Roux-en-Y Reconstruction

Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.

Group Type EXPERIMENTAL

Uncut Roux-en-Y Reconstruction

Intervention Type PROCEDURE

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.

Billroth II Reconstruction

Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.

Group Type ACTIVE_COMPARATOR

Billroth II Reconstruction

Intervention Type PROCEDURE

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.

Interventions

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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

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Aiping shi

Assisted Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Quan Wang, professor

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Locations

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the first hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Yang, postgraduate

Role: CONTACT

18243052038

Facility Contacts

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Dong Yang, master

Role: primary

Quan Wang, proffessor

Role: backup

References

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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.

Reference Type DERIVED
PMID: 38421211 (View on PubMed)

Other Identifiers

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714488468

Identifier Type: OTHER

Identifier Source: secondary_id

130021

Identifier Type: -

Identifier Source: org_study_id

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