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

Completed

• Conditions: Gastrectomy; Gastric Cancer

• Registration Number: NCT06758934
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

Study Timeline

• Study Start: 2024-08-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Textbook Outcome	30 days	The criteria required for a patient who underwent total gastrectomy to have reached a textbook outcome are as follows: * no intraoperative complication,; * achievement of tumor-negative margin,; * 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

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey