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

December 28, 2024 updated by: Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Study Chair: Alpen Yahya Gümüşoğlu, Ass. Prof. Dr., University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 28, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and analysed during the current study are not available due to institutional policies but are available from the corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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