Tubo-ovarian AbscessNCT04817631
Management of Tubo-ovarian Abscess: a Single Center Experience
An observational study of Tubo-ovarian Abscess, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Electronic database of our tertiary obstetrics and gynecology clinic was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tubo-ovarian Abscess
- What is being tested?
- tuboovarian abscess
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2010to 1 Nov 2020
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: Women over 18 years of age who presented to our clinic with symptoms of infection and where tuboovarian abscess was suspected with physical and ultrasonographic examination are included in this study
Who may be able to join
- presence of a pelvic mass > 3 cm with transvaginal ultrasound or magnetic resonance imaging indication abscess
- cervical and uterine tenderness
- abdominal rebound-defense under physical examination indication peritoneal irritation
- presence of symptoms such as fever, pelvic pain and increase in laboratory infection parameters
Who cannot join
- Patients with known malignities
- Patients with incomplete data in the clinic's electronic database
- Patients who continued their treatment at other centers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, 34371
About this study
Official title: Management of Tuba-ovarian Abscess: a 10 Year Single-center Experience
Electronic database of our tertiary obstetrics and gynecology clinic was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities.
Read the detailed description
This retrospective study is conducted at Health Sciences University Turkey, Sisli Hamidiye Etfal Training and Research Hospital Department of Obstetrics and Gynecology. Electronic database was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities. A change in management strategy over the years if any will be reported.
- Conditions
- Tubo-ovarian Abscess
- Being tested
- tuboovarian abscess
- Keywords
- abscess drainage, abscess size, medical treatment, surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tuboovarian abscessOther
Evaluating the surgical and medical management of tuboovarian abscess
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the management of tuboovarian abscess on the basis of surgical or medical modalities by assessing hospitalization duration and recurrence
Patients' demographics data (age, gravity, parity, presence of additional comorbidities and BMI) will be recorded. Their laboratory assessment of infection prior to treatment begin such as CRP an procalcitonin will be recorded. Their treatment modalities in terms of surgery or antibiothepry, duration of hospitalization and recurrence will be recorded. Statistical analysis will be done using SPSS. Student's t test will be used for comparison where necessary. Significance will be evaluated using p-value.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jan 2010
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubo-ovarian AbscessStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nura Fitnat Topbas Selcuki, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817631
- Sponsor's protocol ID
- TOA
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 26 Mar 2021
- 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 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Tuba-ovarian Abscess: a 10 Year Single-center Experience
- ClinicalTrials.gov ID
- NCT04817631
- Acronym / sponsor ID
- TOA
- Conditions
- Tubo-ovarian Abscess
- Keywords
- abscess drainage, abscess size, medical treatment, surgical treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 26 Mar 2021 (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.
Electronic database of our tertiary obstetrics and gynecology clinic was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities.
Detailed description
This retrospective study is conducted at Health Sciences University Turkey, Sisli Hamidiye Etfal Training and Research Hospital Department of Obstetrics and Gynecology. Electronic database was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities. A change in management strategy over the years if any will be reported.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women over 18 years of age who presented to our clinic with symptoms of infection and where tuboovarian abscess was suspected with physical and ultrasonographic examination are included in this study
Key inclusion criteria (4 listed)
- presence of a pelvic mass > 3 cm with transvaginal ultrasound or magnetic resonance imaging indication abscess
- cervical and uterine tenderness
- abdominal rebound-defense under physical examination indication peritoneal irritation
- presence of symptoms such as fever, pelvic pain and increase in laboratory infection parameters
Key exclusion criteria (3 listed)
- Patients with known malignities
- Patients with incomplete data in the clinic's electronic database
- Patients who continued their treatment at other centers
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 |
|---|---|---|
| tuboovarian abscessEvaluating the surgical and medical management of tuboovarian abscess | Other | – |
Primary outcome
Evaluating the management of tuboovarian abscess on the basis of surgical or medical modalities by assessing hospitalization duration and recurrence
Time frame: 10 years
Patients' demographics data (age, gravity, parity, presence of additional comorbidities and BMI) will be recorded. Their laboratory assessment of infection prior to treatment begin such as CRP an procalcitonin will be recorded. Their treatment modalities in terms of surgery or antibiothepry, duration of hospitalization and recurrence will be recorded. Statistical analysis will be done using SPSS. Student's t test will be used for comparison where necessary. Significance will be evaluated using p-value.
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 26 Mar 2021.
- Individual participant dataSharing planned: No
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 Tubo-ovarian Abscess, run by Sisli Hamidiye Etfal Training and Research 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 4 inclusion and 3 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 26 Mar 2021. 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?
Evaluating the management of tuboovarian abscess on the basis of surgical or medical modalities by assessing hospitalization duration and recurrence (time frame: 10 years). 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 26 Mar 2021.