Comparison of Delta-Shaped and Billroth II After TLDG (TLDG)

February 21, 2015 updated by: Quan Wang, The First Hospital of Jilin University

Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delta-shaped anastomosis group
The patients in DS group underwent Delta-shaped anastomosis after TLDG.
Procedure: Delta-shaped anastomosis
The patients in DS group underwent Delta-shaped anastomosis after TLDG.
Experimental: Billroth II anastomosis group
The patients in B-II group underwent Billroth-II anastomosis after TLDG.
Procedure: Billroth II anastomosis
The patients in B-II group underwent Billroth-II anastomosis after TLDG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stage distribution
Time Frame: up to 7 days after the operation
up to 7 days after the operation
Resected margin
Time Frame: up to 7 days after the operation
up to 7 days after the operation
Operative time
Time Frame: up to 7 days after the operation
up to 7 days after the operation
Anastomosis time
Time Frame: up to 7 days after the operation
up to 7 days after the operation
The number of stapler cartridges used
Time Frame: up to 7 days after the operation
up to 7 days after the operation
Median estimated blood loss
Time Frame: up to 7 days after the operation
up to 7 days after the operation
Red blood cell transfusion
Time Frame: up to 7 days after the operation
up to 7 days after the operation
Length of the incision
Time Frame: up to 7 days after the operation
up to 7 days after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication
Time Frame: up to 30 days after the operation
Major complications includes anastomosis leakage and intrabdominal bleeding . Minor complications includes bile regurgitation,anastomotic stenosis and delayed gastric emptying.
up to 30 days after the operation

Collaborators and Investigators

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

Sponsor

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

October 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

February 21, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 21, 2015

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-179

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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