An interventional study of Open Gastrectomy and Laparoscopic Gastrectomy in Gastric Cancer, sponsored by UMC Utrecht. Completed at 10 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 210 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Procedure: Open Gastrectomy
Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.
Procedure: Laparoscopic Gastrectomy
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.
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
Perioperative blood loss
Measured in milliliters (ml)
Time frame: Post-operative day 1
Operative time
The time from incision to closure of all wounds in minutes (min)
Time frame: Post-operative day 1
Conversion rate
The percentage (%) of laparoscopic gastrectomies that had to be converted intra-operatively to an open procedure due to any reason.
Time frame: Post-operative day 1
Survival
Measured as 5-year disease free survival and 5-year overall survival
Time frame: Up to 5 years post-operative
VAS-score
Time frame: Post-operative day 1 and 2
Surgeons ergonomics
Measured with the Subjective Mental Effort Questionnaire (SMEQ)
Time frame: Post-operative day 1
Time to return to normal nutritional regime
Time frame: Up to 5 years post-operative
Time to return to daily activity
Time frame: Up to 5 years post-operative
Plan to share: Yes — Individual participant data that underlie the results reported in the primary manuscript will be shared after de-identification (text, tables, figures, and appendices).
Supporting information: Study protocol, Icf, Analytic code
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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UMC Utrecht