Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34147
- Bakirkoy Dr. Sadi Konuk Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Textbook Outcome
Time Frame: 30 days
|
The criteria required for a patient who underwent total gastrectomy to have reached a textbook outcome are as follows:
|
30 days
|
Collaborators and Investigators
Investigators
- Study Chair: Alpen Yahya Gümüşoğlu, Ass. Prof. Dr., University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20240213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.