Comparison of Delta-Shaped and Billroth II After TLDG

NCT ID: NCT02372747

Last Updated: 2015-02-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).

Detailed Description

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Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Delta-shaped anastomosis group

The patients in DS group underwent Delta-shaped anastomosis after TLDG.

Group Type EXPERIMENTAL

Delta-shaped anastomosis

Intervention Type PROCEDURE

The patients in DS group underwent Delta-shaped anastomosis after TLDG.

Billroth II anastomosis group

The patients in B-II group underwent Billroth-II anastomosis after TLDG.

Group Type EXPERIMENTAL

Billroth II anastomosis

Intervention Type PROCEDURE

The patients in B-II group underwent Billroth-II anastomosis after TLDG.

Interventions

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Delta-shaped anastomosis

The patients in DS group underwent Delta-shaped anastomosis after TLDG.

Intervention Type PROCEDURE

Billroth II anastomosis

The patients in B-II group underwent Billroth-II anastomosis after TLDG.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* carcinoma located in the lower 1/3 of gastric body or antrum of stomach
* diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
* diameter of the tumor \<3cm
* no pyloric obstruction

Exclusion Criteria

* diameter of the tumor ≥3cm
* associated with obstruction, bleeding, emergency surgery or surgical intervention
* tumor with extensive metastasis
* patient had previously undergone gastrostomy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Quan Wang

Deputy Director of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Quan Wang, Doctor

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Other Identifiers

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2013-179

Identifier Type: -

Identifier Source: org_study_id

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