Clinical trial NCT06758934: Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer
Official title: Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrectomy
Gastric Cancer
Keywords: Total Gastrectomy
Textbook Outcome
Open Gastrectomy
Minimally Invasive Surgery
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastric cancer patients ≥ 18 years old and underwent total gastrectomy with curative intent

Brief summary: Gastric cancer patients underwent total gastrectomy with curative intent between in a single center were included in this retrospective study. Patients divided to two groups as open and laparoscopic groups and compared in terms of demographic data, tumor characteristics, operative data and textbook outcome

Detailed description: Gastric cancer patients underwent total gastrectomy with curative intent between July 2018 and January 2024 in a single center were included in this retrospective observational study. Enrolled patients divided to two groups as open total gastrectomy (open group) and laparoscopic total gastrectomy (lap group).

Data of patients obtained via the hospital software system. Demographic data, body mass index(BMI), Charlson comorbidity index (CCI) score and baseline characteristics, operative and postoperative results, tumor characteristics and textbook outcome results were investigated. Postoperative complications were pancreatic fistula, pleural effusion, pneumonia, anastomotic leak, intraabdominal abscess, surgical site infection, postoperative ileus.

All patients were already curative surgery patients and underwent total gastrectomy and D2 lymphadenectomy. Apart from this, the list of criteria for a patient who had a textbook outcome was as follows: no intraoperative complication, achievement of tumor-negative margins, including ≥15 harvested lymph nodes in resected specimen, no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), no reintervention, no readmission to intensive care unit after once coming to the surgical ward, no prolonged hospital stay (≤21 days), no postoperative mortality (30 days) and no readmission after discharge from the hospital

Eligibility criteria: Inclusion Criteria:

* Gastric cancer patients underwent total gastrectomy with curative intent

Exclusion Criteria:

* Emergency surgery,
* Recurrent disease
* Metastatic disease,
* Conversion to open surgery,
* Robotic gastrectomy.

Primary outcomes:
measure: Textbook Outcome
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Study officials:
affiliation: University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital
name: Alpen Yahya Gümüşoğlu, Ass. Prof. Dr.
role: STUDY_CHAIR
References: