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Clinical Trials/NCT06798610
NCT06798610CompletedNot Applicable

The Impact of the Inflammation Index on Predicting Postoperative Complications in Ovarian Cancer

Sakarya University1 site in 1 country228 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
228
Locations
1
Primary Endpoint
Correlation Between Preoperative Inflammatory Markers and Postoperative Complications

Study Overview

Brief Summary

Advanced-stage ovarian cancer surgery is a procedure that inherently carries a high risk of mortality and morbidity. However, there are some uncertainties regarding whether these complications can be predicted before the operation. In this study, we aimed to examine the relationship between complications and inflammation.

Detailed Description

Objective

Cytoreductive surgery (CRS) is the most important treatment method that increases survival in advanced-stage ovarian cancer patients. However, complications after CRS are seen as a significant cause of morbidity and mortality. Preoperative risk assessment of patients is of great importance. In recent years, inflammatory markers have been the subject of many studies evaluating malignancy and surgical outcomes. Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), systemic inflammation index (SII), and systemic inflammatory response index (SIRI) stand out as prognostic and predictive tools in malignancies. This study aims to evaluate the preoperative inflammatory markers in patients who underwent CRS for advanced-stage epithelial ovarian cancer and to investigate the predictive power of postoperative complications.

Materials and Methods

This retrospective study examines patients who underwent CRS due to advanced-stage epithelial OC at Sakarya University Training and Research Hospital between 2014 and 2023. Postoperative complications of the patients were graded according to the Clavien-Dindo classification; NLR, PLR, SII, and SIRI values were calculated using preoperative laboratory data, and the predictive values of inflammatory markers were analyzed with ROC curves.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The inclusion criteria of the patients were determined as those who underwent surgery with the diagnosis of FIGO Stage IIIc and IV epithelial ovarian cancer.

Exclusion Criteria

  • •The exclusion criteria of the study were patients who had recently undergone blood transfusion or bacterial or viral infection within two weeks before surgery.
  • •Pregnant patients or patients with hematological diseases.
  • •Patients with thrombotic diseases.
  • •Patients with immunological diseases.
  • •Patients with severe liver or kidney diseases, patients with a previous history of cancer.
  • •Patients receiving anticoagulant and/or antiplatelet therapy due to venous or arterial thromboembolism.

Outcomes

Primary Outcomes

Correlation Between Preoperative Inflammatory Markers and Postoperative Complications

Time Frame: Preoperative inflammatory markers will be measured within 1 week before surgery. Postoperative complications will be assessed within 30 days after surgery.

This measure will examine the relationship between preoperative inflammatory markers and postoperative complications. The levels of inflammatory markers may be used to predict the risk of complications and can guide treatment approaches aimed at improving the recovery process following surgery.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sakarya University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

OSMAN KÖSE, MD

assistant professor

Sakarya University

Study Sites (1)

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