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

NCT06758934 | Completed

• 1 other identifier: 20240213
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrectomy; Gastric Cancer

Keywords

Total Gastrectomy; Textbook Outcome; Open Gastrectomy; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Textbook Outcome

  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

  30 days

Study Arms (2)

Open Group

Gastric cancer patients underwent open total gastrectomy with curative intent between July 2018 and January 2024

Lap Group

Gastric cancer patients underwent laparoscopic total gastrectomy with curative intent between July 2018 and January 2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastric cancer patients ≥ 18 years old and underwent total gastrectomy with curative intent

You may qualify if:

• Gastric cancer patients underwent total gastrectomy with curative intent

You may not qualify if:

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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Alpen Yahya Gümüşoğlu, Ass. Prof. Dr.

  University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dr.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 6, 2025
• Study Start: August 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)