Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer

NCT ID: NCT04481828

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2020-01-31

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.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

open gastrectomy

The first group (Group 1; n: 30) consisted of patients who underwent open surgery

gastrectomy

Intervention Type: PROCEDURE

gastric resection with lymph node dissection(D1+,D2) for stomach cancer.

laparoscopic gastrectomy

The second group (group 2; n:30) consisted of patients who underwent laparoscopic gastrectomy

gastrectomy

Intervention Type: PROCEDURE

gastric resection with lymph node dissection(D1+,D2) for stomach cancer.

Interventions

gastrectomy

gastric resection with lymph node dissection(D1+,D2) for stomach cancer.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Adem Yuksel

M.D. Department of Gastroenterological surgery,Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli Derince Training and research Hospital

Kocasinan, Derince, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27401443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28730391 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26603678 (View on PubMed)

Other Identifiers

2019-98

Identifier Type: -

Identifier Source: org_study_id