Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. In this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in Turkey.

Detailed Description
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The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical staging was done using contrast computed tomography (CT). Positron emission tomography (PET) was used in patients with suspected metastasis.The patients were divided into two groups according to the technique applied (open, laparotomy). The first group (Group 1; n: 30) consisted of patients who underwent open surgery, and the second group (Group 2, n: 30) laparoscopic surgery.

Official Title
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Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric cancer(adenocarcinoma) proven biopsy Operated by same surgical team Presence of distant metastasis Exclusion Criteria: Patients who underwent palliative resection operated by a different surgical team ASA score: 4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| open gastrectomy<br>The first group (Group 1; n: 30) consisted of patients who underwent open surgery | Procedure: gastrectomy<br>* gastric resection with lymph node dissection(D1+,D2) for stomach cancer.<br>|
| laparoscopic gastrectomy<br>The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy | Procedure: gastrectomy<br>* gastric resection with lymph node dissection(D1+,D2) for stomach cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | year | 2014-2019 | 
| Body mass index | kg/m2 | 2014- 2019 | 
| Previous abdominal surgery status | yes or no | 2014-2019 | 
| Comorbidity status | present or absent | 2014 -2019 | 
| Neoadjuvant therapy status | present or absent | 2014-2019 | 
| American Society of Anesthesiologists (ASA) score | 1,2,3,4 | 2014-2019 | 
| Gender | male or female | 2014-2019 | 
| Surgical technique | open or laparoscopic | 2014-2019 | 
| Tumor localization | proximal, middle, lower | 2014 - 2019 | 
| Gastrectomy type | total, subtotal | 2014 - 2019 | 
| Lymph node dissection type | D1+, D2 | 2014 - 2019 | 
| Operation time | minute | 2014 - 2019 | 
| Blood loss | ml | 2014 - 2019 | 
| Complication (Clavien-Dindo Classification) | 1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification) | 2014 - 2019 | 
| 30-day mortality | present or absent | 2014 - 2019 | 
| Number of harvested lymph node | number | 2014 - 2019 | 
| Resection margin status | positive or negative | 2014 - 2019 | 
| Tumor stage (American Joint Committee on Cancer 8th Edition) | 0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition) | 2014 - 2019 |