Disease (or Disorder); GynecologicalNCT02405936
Prospective Data Collection of Patients Undergoing Gynecologic Surgery
An observational study of Disease (or Disorder); Gynecological, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of this prospective study is to collect data on patients undergoing gynecologic surgery at Kangbuk Samsung Hospital. Read more about this study
- Who is it for?
- Ages 16 to 80 years, women only
- Conditions the study is for
- Disease (or Disorder); Gynecological
- What is being tested?
- Gynecologic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 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 16 to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015
Who may be able to join
- All patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015
Who cannot join
- None
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
The aim of this prospective study is to collect data on patients undergoing gynecologic surgery at Kangbuk Samsung Hospital.
Read the detailed description
The aim of this prospective study is to collect data on patients undergoing gynecologic surgery 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
- Disease (or Disorder); Gynecological
- Being tested
- Gynecologic surgery
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecologic surgeryProcedure or surgery
The researchers prospectively will collect data on all patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective data collection of patients undergoing gynecologic surgery
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 posted1 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease (or Disorder); GynecologicalStudies 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
- 3,000 participants (estimated)
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, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405936
- Sponsor's protocol ID
- 2014-11-009-002
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 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 Undergoing Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT02405936
- Acronym / sponsor ID
- 2014-11-009-002
- Conditions
- Disease (or Disorder); Gynecological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Apr 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 patients undergoing gynecologic surgery at Kangbuk Samsung Hospital.
Detailed description
The aim of this prospective study is to collect data on patients undergoing gynecologic surgery 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
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015
Key inclusion criteria (1 listed)
- All patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Gynecologic surgeryThe researchers prospectively will collect data on all patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015. | Procedure or surgery | – |
Primary outcome
Prospective data collection of patients undergoing gynecologic surgery
Time frame: 10 years
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, Seoul, Republic of Korea
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 Disease (or Disorder); Gynecological, 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 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: 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 (82-2-2001-2582, taejong.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective data collection of patients undergoing gynecologic surgery (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.