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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Patients 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.
Zorggroep Twente Almelo
Almelo, Netherlands
Meander Medical Center
Amersfoort, Netherlands
VU University Medical Center
Amsterdam, Netherlands
Academic Medical Center
Amsterdam, Netherlands
Gelre Hospital
Apeldoorn, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Zuyderland Medical Center
Sittard-Geleen, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Post-operative hospital stay
The primary outcome of this study is the post-operative hospital stay (days), since this is considered a strong end point as it reflects the impact of the different surgical procedures.
Time frame: During admission, an expected average of 2 weeks
Mortality
Measured as 30-day mortality rate
Time frame: 30 days post-operative
Post-operative morbidity
Complications will be classified according to the Clavien-Dindo system and include anastomotic leakage, anastomotic stricture, respiratory complications, cardiac complications, intra-abdominal bleeding , intra-abdominal abscess, sepsis, ileus, wound infection, fistula, urinary tract infection and dumping syndrome
Time frame: Up to 5 years post-operative
Cost-effectiveness
Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation
Time frame: Up to 5 years post-operative
Quality of Life
The validated quality of life questionnaires EORTC QLQ-30, EORTC QLQ-STO22 and EQ-5D-5L, will be filled in pre-operative \<5 days and post-operative at 6 weeks, 12, 24, 36, 48 and 60 months after surgery.
Time frame: Up to 5 years post-operative
Readmissions
The number of post-operative readmissions
Time frame: Up to 5 years post-operative
Oncologic outcomes (R0-resection rate and lymph node yield)
R0-resection rate of the distal and proximal margin, defined according to the College of American Pathologists. Lymph node yield: the amount of harvested lymph nodes per patient.
Time frame: Pathology report 1-2 weeks after surgery
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