ComplicationsNCT06798610
The Impact of the Inflammation Index on Predicting Postoperative Complications in Ovarian Cancer
An observational study of Complications and Ovarian Cancer, run by Sakarya University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Complications, Ovarian Cancer
- How many people
- 228 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sakarya University Faculty of Medicine
Adapazarı, Sakarya, 54290
Sakarya University Faculty of Medicine
Sakarya, 54050
About this study
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.
Read the 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.
- Conditions
- Complications, Ovarian Cancer
- Keywords
- inflammation markers, complications, ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative inflammatory markers will be measured within 1 week before surgery. Postoperative complications will be assessed within 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OSMAN KÖSE, MD, Sakarya University
- Investigators
- osman köse, ass. proff., Study director, Sakarya University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798610
- Sponsor's protocol ID
- E.309436-346
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Inflammation Index on Predicting Postoperative Complications in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06798610
- Acronym / sponsor ID
- E.309436-346
- Conditions
- Complications, Ovarian Cancer
- Keywords
- inflammation markers, complications, ovarian cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
osman köse, ass. proff. study director
Sakarya University Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications and Ovarian Cancer, run by Sakarya University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.