Inflammatory Pelvic DiseaseNCT02567812
Database of Pelvic Inflammatory Disease
An observational study of Inflammatory Pelvic Disease, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Inflammatory Pelvic Disease
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Sep 2024
- 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 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pelvic inflammatory disease or pelvic inflammatory disorder (PID) is an infection of the upper part of the female reproductive system namely the uterus, fallopian tubes, or the ovaries. Often there may be no symptoms. Signs and symptoms, when present may include lower abdominal pain, vaginal discharge, fever, burning with urination, pain with sex, or irregular menstruation. Untreated PID can result in long term complications including infertility, ectopic pregnancy, chronic pelvic pain, and cancer.
Who may be able to join
- All in-patient with PID who diagnosed at Kangbuk Samsung Hospital
Who cannot join
- Secondary PID caused by other surgical problem or disease
- An inability to fill-up the informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangbuk Samsung Hospital
Seoul, 110-746
Taejong Song, MD PhD, 82-2-2001-2582, taejong.song@gmail.com
Taejong Song, MD, PhD
About this study
Official title: Prospective Data Collection of Patients With Pelvic Inflammatory Disease
The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital.
Read the detailed description
The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital. If patients agree to participate in this clinical trial, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.
- Conditions
- Inflammatory Pelvic Disease
- Medical subject headings
- Pelvic Inflammatory Disease
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 |
|---|---|---|
| In-patient with PID | In-patient with PID who diagnosed at Kangbuk Samsung Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
PID database
number of participants with pelvic inflammatory disease
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 posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Pelvic DiseaseStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD PhD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567812
- Sponsor's protocol ID
- 2015-04-009
- Status last verified
- Apr 2019
- First submitted
- 1 Oct 2015
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection of Patients With Pelvic Inflammatory Disease
- ClinicalTrials.gov ID
- NCT02567812
- Acronym / sponsor ID
- 2015-04-009
- Conditions
- Inflammatory Pelvic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- 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.
The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital.
Detailed description
The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital. If patients agree to participate in this clinical trial, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-patient with PID | – | –In-patient with PID who diagnosed at Kangbuk Samsung Hospital |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pelvic inflammatory disease or pelvic inflammatory disorder (PID) is an infection of the upper part of the female reproductive system namely the uterus, fallopian tubes, or the ovaries. Often there may be no symptoms. Signs and symptoms, when present may include lower abdominal pain, vaginal discharge, fever, burning with urination, pain with sex, or irregular menstruation. Untreated PID can result in long term complications including infertility, ectopic pregnancy, chronic pelvic pain, and cancer.
Key inclusion criteria (1 listed)
- All in-patient with PID who diagnosed at Kangbuk Samsung Hospital
Key exclusion criteria (2 listed)
- Secondary PID caused by other surgical problem or disease
- An inability to fill-up the informed consent
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
PID database
Time frame: 10 years
number of participants with pelvic inflammatory disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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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.
Taejong Song, MD PhD principal investigator
Kangbuk Samsung Hospital
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 Inflammatory Pelvic Disease, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taejong Song, MD PhD (+82-10-4035-8405, taejong.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PID database (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 3 Apr 2019.