Comparison of Delta-Shaped and Billroth II After TLDG

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Delta-shaped anastomosis; Procedure: Billroth II anastomosis

• Registration Number: NCT02372747
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

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

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 Timeline

• Status Verified: 2006-02
• Study Start: 2012-10
• Primary Completion: 2013-11
• Study Completion: 2014-12
• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-02-21
• Last Update Submitted: 2015-02-21
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delta-shaped anastomosis group	Delta-shaped anastomosis	The patients in DS group underwent Delta-shaped anastomosis after TLDG.
Billroth II anastomosis group	Billroth II anastomosis	The patients in B-II group underwent Billroth-II anastomosis after TLDG.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative complication	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.