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

NCT ID: NCT06758934

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-10-01

Brief Summary

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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

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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

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Gastrectomy Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Open Group

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

No interventions assigned to this group

Lap Group

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Turgut Donmez

Ass. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alpen Yahya Gümüşoğlu, Ass. Prof. Dr.

Role: STUDY_CHAIR

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

Locations

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Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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20240213

Identifier Type: -

Identifier Source: org_study_id

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