Comparison of Delta-Shaped and Billroth II After TLDG

Study Overview
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Delta-shaped anastomosis
* Procedure: Billroth II anastomosis


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage distribution |  | up to 7 days after the operation | 
| Resected margin |  | up to 7 days after the operation | 
| Operative time |  | 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 | 
| Median estimated blood loss |  | up to 7 days after the operation | 
| Red blood cell transfusion |  | up to 7 days after the operation | 
| Length of the incision |  | up to 7 days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Totally laparoscopic gastrectomy, laparoscopic distal gastrectomy, Intracorporeal anastomosis, Delta-Shaped Anastomosis, Billroth II Anastomosis, Gastric cancer