Kocaeli Derince Training and research Hospital
Kocasinan, Derince, 41900, Turkey (Türkiye)
Completed
NCT Number: NCT04481828
Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
gastrectomy
Proceduregastric resection with lymph node dissection(D1+,D2) for stomach cancer.
Primary outcomes
-
Age
Time frame: 2014-2019
year
-
Body mass index
Time frame: 2014- 2019
kg/m2
-
Previous abdominal surgery status
Time frame: 2014-2019
yes or no
-
Comorbidity status
Time frame: 2014 -2019
present or absent
-
Neoadjuvant therapy status
Time frame: 2014-2019
present or absent
-
American Society of Anesthesiologists (ASA) score
Time frame: 2014-2019
1,2,3,4
-
Gender
Time frame: 2014-2019
male or female
-
Surgical technique
Time frame: 2014-2019
open or laparoscopic
-
Tumor localization
Time frame: 2014 - 2019
proximal, middle, lower
-
Gastrectomy type
Time frame: 2014 - 2019
total, subtotal
-
Lymph node dissection type
Time frame: 2014 - 2019
D1+, D2
-
Operation time
Time frame: 2014 - 2019
minute
-
Blood loss
Time frame: 2014 - 2019
ml
-
Complication (Clavien-Dindo Classification)
Time frame: 2014 - 2019
1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)
-
30-day mortality
Time frame: 2014 - 2019
present or absent
-
Number of harvested lymph node
Time frame: 2014 - 2019
number
-
Resection margin status
Time frame: 2014 - 2019
positive or negative
-
Tumor stage (American Joint Committee on Cancer 8th Edition)
Time frame: 2014 - 2019
0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)
Sponsors and collaborators
Lead sponsor
Kocaeli Derince Education and Research Hospital
Other
Registry information
Official study title
Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center
Important dates
- Study start
- 2014
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Jul 22, 2020
- Registry last updated
- Jul 22, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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