Clinical Trials Directory

Trials / Completed

CompletedNCT06758934

Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer

Status
Completed
Phase
Study type
Observational
Enrollment
94 (actual)
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2024-08-01
Primary completion
2024-09-01
Completion
2024-10-01
First posted
2025-01-06
Last updated
2025-01-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06758934. Inclusion in this directory is not an endorsement.