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

NCT06798610 | Completed

• 1 other identifier: E.309436-346
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 2

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.

Conditions

Complications; Ovarian Cancer

Keywords

inflammation markers; complications; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Correlation Between Preoperative Inflammatory Markers and Postoperative Complications

  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.

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

Study Arms (1)

Patients who underwent cytoreductive surgery due to advanced-stage ovarian cancer

The study will investigate the complications that develop within one month following cytoreductive surgery in patients with advanced-stage ovarian cancer. It will explore the relationship between these complications and preoperative inflammatory markers

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes patients who underwent cytoreductive surgery for FIGO Stage IIIc and IV epithelial ovarian cancer between January 1, 2014, and December 31, 2023. Individuals who had received blood transfusion or had an infection prior to surgery, those with immunological or hematological diseases, patients with an ECOG performance score \>3, those with a history of cancer, patients with venous thromboembolism history, and those recommended for neoadjuvant chemotherapy were excluded. Participants were evaluated for complications that could develop within 30 days after surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (2)

Sakarya University Faculty of Medicine

Adapazarı, Sakarya, 54290, Turkey (Türkiye)

Location

Sakarya University Faculty of Medicine

Sakarya, 54050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• osman köse, ass. proff.

  Sakarya University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 29, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)