Women With Ovarian CystNCT05946889
Comparisons of Human Fibrin Glue (Tisseel) Versus Suture and Robotic Versus Traditional Laparoscopy for Ovarian Cystectomy
An observational study of Women With Ovarian Cyst, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Objective: To compare the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Women With Ovarian Cyst
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Sep 2022to 9 Aug 2023
- 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 20 years and older
- Women only
- Adult, Older adult
Study population: Patients who received ovarian cystectomy
Who may be able to join
- >20 years old women
- women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed.
Who cannot join
- Patients who underwent myomectomy at the same time.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
Objective: To compare the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy
Read the detailed description
Methods: The medical records of all consecutive women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed. Perioperative outcome and ovarian size were compared.
Expected results: We can get the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy. The above information should be important for consultation.
- Conditions
- Women With Ovarian Cyst
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 |
|---|---|---|
| Suture | Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with suture | |
| Human Fibrin Glue | Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with human fibrin glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian size
the ovarian size after ovarian cystectomy during follow-up
Measured: 24 months
Secondary outcomes (1)
Blood loss
Estimated blood loss during perioperative period (including abdominal drainage)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start23 Sep 2022
- Primary completion27 Jul 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Ovarian CystStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946889
- Sponsor's protocol ID
- 111192-E
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Human Fibrin Glue (Tisseel) Versus Suture and Robotic Versus Traditional Laparoscopy for Ovarian Cystectomy
- ClinicalTrials.gov ID
- NCT05946889
- Acronym / sponsor ID
- 111192-E
- Conditions
- Women With Ovarian Cyst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 14 Jul 2023 (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.
Objective: To compare the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy
Detailed description
Methods: The medical records of all consecutive women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed. Perioperative outcome and ovarian size were compared.
Expected results: We can get the effects of suture versus human fibrin glue during robotic or laparoscopic ovarian cystectomy. The above information should be important for consultation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | – | –Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with suture |
| Human Fibrin Glue | – | –Women with ovarian cyst who received robotic/laparoscopic ovarian cystectomy with human fibrin glue |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients who received ovarian cystectomy
Key inclusion criteria (2 listed)
- >20 years old women
- women who received robotic or laparoscopic ovarian cystectomy between January 2016 and May 2022 were reviewed.
Key exclusion criteria (1 listed)
- Patients who underwent myomectomy at the same time.
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
Ovarian size
Time frame: 24 months
the ovarian size after ovarian cystectomy during follow-up
1 secondary outcome
Blood loss
Time frame: 1 week
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 13 Sep 2023.
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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 Women With Ovarian Cyst, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 2 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 13 Sep 2023. 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 Taiwan. 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?
Ovarian size (time frame: 24 months). 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 13 Sep 2023.