Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT04481828
• Lead Sponsor: Kocaeli Derince Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2019-12
• Study Completion: 2020-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kocaeli Derince Training and research Hospital; 🇹🇷 Kocasinan, Derince, Turkey

Kocaeli Derince Training and research Hospital

🇹🇷Kocasinan, Derince, Turkey