Clinical trial NCT04481828: Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer
Official title: Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Age
timeFrame: 2014-2019
measure: Body mass index
timeFrame: 2014- 2019
measure: Previous abdominal surgery status
timeFrame: 2014-2019
measure: Comorbidity status
timeFrame: 2014 -2019
measure: Neoadjuvant therapy status
timeFrame: 2014-2019
measure: American Society of Anesthesiologists (ASA) score
timeFrame: 2014-2019
measure: Gender
timeFrame: 2014-2019
measure: Surgical technique
timeFrame: 2014-2019
measure: Tumor localization
timeFrame: 2014 - 2019
measure: Gastrectomy type
timeFrame: 2014 - 2019
measure: Lymph node dissection type
timeFrame: 2014 - 2019
measure: Operation time
timeFrame: 2014 - 2019
measure: Blood loss
timeFrame: 2014 - 2019
measure: Complication (Clavien-Dindo Classification)
timeFrame: 2014 - 2019
measure: 30-day mortality
timeFrame: 2014 - 2019
measure: Number of harvested lymph node
timeFrame: 2014 - 2019
measure: Resection margin status
timeFrame: 2014 - 2019
measure: Tumor stage (American Joint Committee on Cancer 8th Edition)
timeFrame: 2014 - 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Kocasinan
country: Turkey
facility: Kocaeli Derince Training and research Hospital
state: Derince
Study officials:
References:
citation: Okabe H, Tsunoda S, Obama K, Tanaka E, Hisamori S, Shinohara H, Sakai Y. Feasibility of Laparoscopic Radical Gastrectomy for Gastric Cancer of Clinical Stage II or Higher: Early Outcomes in a Phase II Study (KUGC04). Ann Surg Oncol. 2016 Aug;23(Suppl 4):516-523. doi: 10.1245/s10434-016-5383-0. Epub 2016 Jul 11.
citation: van der Wielen N, Straatman J, Cuesta MA, Daams F, van der Peet DL. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature. Gastric Cancer. 2018 Jan;21(1):19-30. doi: 10.1007/s10120-017-0747-0. Epub 2017 Jul 20.
citation: Haverkamp L, Ruurda JP, Offerhaus GJ, Weijs TJ, van der Sluis PC, van Hillegersberg R. Laparoscopic gastrectomy in Western European patients with advanced gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):110-5. doi: 10.1016/j.ejso.2015.09.018. Epub 2015 Oct 22.