Gynecologic CancersNCT07077629
Geriatric Patients Undergoing Gynaecological Cancer Surgery
An observational study of Gynecologic Cancers, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sınce old age includes variables such as genetics, chronic diseases, lifestyle, aging can be classified as chronological, social, physiological and psychological. According to the World Health Organization's chronological classification, 0-18 years old is considered adolescent, 18-65 years old is young, 65-74 years… Read more about this study
- Who is it for?
- Ages 74 to 84 years, women only
- Conditions the study is for
- Gynecologic Cancers
- What is being tested?
- morbidity and mortality
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2025to 30 Jun 2025
- How long will I take part?
- 1 Year
- 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 74 to 84 years
- Women only
- No healthy volunteers
- Older adult
Study population: Patients over the age of 74 who underwent gynecological cancer surgery were evaluated retrospectively.
Who may be able to join
- Patients older than 74 years of age
Who cannot join
- Incomplete or inadequate patient records
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul
About this study
Official title: Relationship of Scoring Systems With Postoperative Morbidity and Mortality in Geriatric Patients Undergoing Gynecologic Cancer Surgery.
Sınce old age includes variables such as genetics, chronic diseases, lifestyle, aging can be classified as chronological, social, physiological and psychological. According to the World Health Organization's chronological classification, 0-18 years old is considered adolescent, 18-65 years old is young, 65-74 years old is young-old, 74-84 years old is old, and over 85 years old is very old. With advancing age, many physiological changes occur in the body and the risk of non-communicable diseases such as heart and respiratory diseases, cancer, and diabetes increases. Geriatric assessment can be defined as a multidimensional diagnostic process aimed at developing a coordinated and integrated plan for treatment and long-term follow-up in order to determine the medical, psychosocial and functional abilities of an elderly person. Therefore, in order to obtain information about mortality and morbidity in patients undergoing geriatric gynecologic cancer surgery, many risk factors will be evaluated and the usability and reliability of scores and indices will be investigated. For this purpose, many risk scores are used.
Read the detailed description
Geriatric assessment can be defined as a multidimensional diagnostic process aimed at developing a coordinated and integrated plan for treatment and long-term follow-up in order to determine the medical, psychosocial and functional abilities of an elderly person. Therefore, in order to obtain information about mortality and morbidity in patients undergoing geriatric gynecologic cancer surgery, many risk factors will be evaluated and the usability and reliability of scores and indices will be investigated. For this purpose, many risk scores are used. There are preoperative ASA clinical classification and many postoperative risk protections. ARISCAT risk score is used to investigate postoperative respiratory complications. It consists of a seven-variable model (age, preoperative oxygen saturation (SpO2), respiratory tract infection in the month before surgery, preoperative anemia, surgical incision, duration of surgery and emergency system of the procedure) that separates patients into low, medium and high groups. One of the risk score calculation methods calculated by evaluating comorbidities is the Charlson Comorbidity Index. This score consists of 17 parameters. Participants will be evaluated with the GA-GYN score, which can be separated in this way for geriatric patients and gynecological cancer group surgery. AC surgical risk score is also a score consisting of many parameters such as patients' comorbidities, surgical procedure performed and calculating the risk of disease and death. Walter index will be calculated in order to evaluate these personal 1-year death estimates.
- Conditions
- Gynecologic Cancers
- Being tested
- morbidity and mortality
- Keywords
- geriatric surgery, scoring systems, mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morbidity and mortalityProcedure or surgery
Relationship of scoring systems with postoperative morbidity and mortality in geriatric patients undergoing gynecologic cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric patients undergoing gynecologic cancer surgery | Relationship of scoring systems with postoperative morbidity and mortality in geriatric patients undergoing gynecologic cancer surgery. Receives: Procedure: morbidity and mortality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Geriatric assesment- Gynaecology( GA-GYN) score with postoperative mortality
In this score, high scores represent poor results. The GA-GYN score consists of eight parameters:
- Need for assistance in taking medications: 1 point
- Limited in walking one block : 2 point
- Decreased social activity at least sometimes due to physical/emotional health (item from social activity survey):1 point
- Number of falls in the last 6 months ≥ 1:3 point
- Fair or worse Hearing: 2 point
- Age >=72 years: 2 point
- Hemoglobin <10 g/dl: 3 point
- Creatinine clearance <34 ml/min: 3 point
Measured: postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start21 May 2025
- Primary completion25 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077629
- Sponsor's protocol ID
- 2025-181
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vacante M, Cristaldi E, Basile F, Borzi AM, Biondi A. Surgical approach and geriatric evaluation for elderly patients with colorectal cancer. Updates Surg. 2019 Sep;71(3):411-417. doi: 10.1007/s13304-019-00650-3. Epub 2019 Apr 5.
PubMed 30953329Wozniak SE, Coleman J, Katlic MR. Optimal Preoperative Evaluation and Perioperative Care of the Geriatric Patient: A Surgeon's Perspective. Anesthesiol Clin. 2015 Sep;33(3):481-9. doi: 10.1016/j.anclin.2015.05.012. Epub 2015 Jul 3.
PubMed 26315633Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026.
PubMed 17116555
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Scoring Systems With Postoperative Morbidity and Mortality in Geriatric Patients Undergoing Gynecologic Cancer Surgery.
- ClinicalTrials.gov ID
- NCT07077629
- Acronym / sponsor ID
- 2025-181
- Conditions
- Gynecologic Cancers
- Keywords
- geriatric surgery, scoring systems, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 21 May 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Jul 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.
Sınce old age includes variables such as genetics, chronic diseases, lifestyle, aging can be classified as chronological, social, physiological and psychological. According to the World Health Organization's chronological classification, 0-18 years old is considered adolescent, 18-65 years old is young, 65-74 years old is young-old, 74-84 years old is old, and over 85 years old is very old. With advancing age, many physiological changes occur in the body and the risk of non-communicable diseases such as heart and respiratory diseases, cancer, and diabetes increases. Geriatric assessment can be defined as a multidimensional diagnostic process aimed at developing a coordinated and integrated plan for treatment and long-term follow-up in order to determine the medical, psychosocial and functional abilities of an elderly person. Therefore, in order to obtain information about mortality and morbidity in patients undergoing geriatric gynecologic cancer surgery, many risk factors will be evaluated and the usability and reliability of scores and indices will be investigated. For this purpose, many risk scores are used.
Detailed description
Geriatric assessment can be defined as a multidimensional diagnostic process aimed at developing a coordinated and integrated plan for treatment and long-term follow-up in order to determine the medical, psychosocial and functional abilities of an elderly person. Therefore, in order to obtain information about mortality and morbidity in patients undergoing geriatric gynecologic cancer surgery, many risk factors will be evaluated and the usability and reliability of scores and indices will be investigated. For this purpose, many risk scores are used. There are preoperative ASA clinical classification and many postoperative risk protections. ARISCAT risk score is used to investigate postoperative respiratory complications. It consists of a seven-variable model (age, preoperative oxygen saturation (SpO2), respiratory tract infection in the month before surgery, preoperative anemia, surgical incision, duration of surgery and emergency system of the procedure) that separates patients into low, medium and high groups. One of the risk score calculation methods calculated by evaluating comorbidities is the Charlson Comorbidity Index. This score consists of 17 parameters. Participants will be evaluated with the GA-GYN score, which can be separated in this way for geriatric patients and gynecological cancer group surgery. AC surgical risk score is also a score consisting of many parameters such as patients' comorbidities, surgical procedure performed and calculating the risk of disease and death. Walter index will be calculated in order to evaluate these personal 1-year death estimates.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric patients undergoing gynecologic cancer surgery | – | Procedure: morbidity and mortalityRelationship of scoring systems with postoperative morbidity and mortality in geriatric patients undergoing gynecologic cancer surgery. |
Who may qualify
- Ages
- 74 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over the age of 74 who underwent gynecological cancer surgery were evaluated retrospectively.
Key inclusion criteria (1 listed)
- Patients older than 74 years of age
Key exclusion criteria (1 listed)
- Incomplete or inadequate patient records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morbidity and mortalityRelationship of scoring systems with postoperative morbidity and mortality in geriatric patients undergoing gynecologic cancer surgery. | Procedure or surgery | Geriatric patients undergoing gynecologic cancer surgery |
Primary outcome
Correlation of Geriatric assesment- Gynaecology( GA-GYN) score with postoperative mortality
Time frame: postoperative 1 year
In this score, high scores represent poor results. The GA-GYN score consists of eight parameters: 1. Need for assistance in taking medications: 1 point 2. Limited in walking one block : 2 point 3. Decreased social activity at least sometimes due to physical/emotional health (item from social activity survey):1 point 4. Number of falls in the last 6 months ≥ 1:3 point 5. Fair or worse Hearing: 2 point 6. Age >=72 years: 2 point 7. Hemoglobin <10 g/dl: 3 point 8. Creatinine clearance <34 ml/min: 3 point
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 25 Jul 2025.
- Results publication: PubMed 30953329Vacante M, Cristaldi E, Basile F, Borzi AM, Biondi A. Surgical approach and geriatric evaluation for elderly patients with colorectal cancer. Updates Surg. 2019 Sep;71(3):411-417. doi: 10.1007/s13304-019-00650-3. Epub 2019 Apr 5.
- Results publication: PubMed 26315633Wozniak SE, Coleman J, Katlic MR. Optimal Preoperative Evaluation and Perioperative Care of the Geriatric Patient: A Surgeon's Perspective. Anesthesiol Clin. 2015 Sep;33(3):481-9. doi: 10.1016/j.anclin.2015.05.012. Epub 2015 Jul 3.
- Results publication: PubMed 17116555Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. J Am Coll Surg. 2006 Dec;203(6):865-77. doi: 10.1016/j.jamcollsurg.2006.08.026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancers, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site 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 1 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 of Geriatric assesment- Gynaecology( GA-GYN) score with postoperative mortality (time frame: postoperative 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077629, which also lists 3 linked publications.
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 25 Jul 2025.