Clinical Trials Directory

Trials / Completed

CompletedNCT02248519

Laparoscopic Versus Open Gastrectomy for Gastric Cancer

Laparoscopic Versus Open Gastrectomy for Gastric Cancer, a Multicenter Prospectively Randomized Controlled Trial (LOGICA-trial)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
210 (actual)
Sponsor
UMC Utrecht · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.

Conditions

Interventions

TypeNameDescription
PROCEDUREOpen GastrectomyPatients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
PROCEDURELaparoscopic GastrectomyPatients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.

Timeline

Start date
2014-12-01
Primary completion
2018-11-01
Completion
2023-12-01
First posted
2014-09-25
Last updated
2026-02-19

Locations

10 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02248519. Inclusion in this directory is not an endorsement.