Laparoscopic or Robotic MetroplastyNCT04414670
Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele
An observational study of Laparoscopic or Robotic Metroplasty, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for uterine isthmocele with the aid of a bending probe. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Laparoscopic or Robotic Metroplasty
- What is being tested?
- C/S
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2020to 29 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: uterine isthmocele status post laparoscopic or robotic metroplasty
Who may be able to join
- > 20 years of women
- uterine isthmocele status post laparoscopic or robotic metroplasty with a bent uterine sound
Who cannot join
- Those underwent traditional open surgery.
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
To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for uterine isthmocele with the aid of a bending probe.
- Conditions
- Laparoscopic or Robotic Metroplasty
- Being tested
- C/S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C/SProcedure or surgery
laparoscopic or robotic metroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of prolonged menstrual bleeding condition
Symptoms improvement and perioperative complications
Measured: 10 years
Secondary outcomes (1)
Change of scar defect size
Symptoms improvement and perioperative complications
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 posted4 Jun 2020
- Study start17 Feb 2020
- Primary completion8 Sep 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic or Robotic MetroplastyStudies 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
- Retrospective
- Enrolment
- 20 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
- NCT04414670
- Sponsor's protocol ID
- 109002-E
- Status last verified
- Feb 2022
- First submitted
- 31 May 2020
- Last updated
- 17 Aug 2022
- Results posted
- 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele
- ClinicalTrials.gov ID
- NCT04414670
- Acronym / sponsor ID
- 109002-E
- Conditions
- Laparoscopic or Robotic Metroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 4 Jun 2020 (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.
To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for uterine isthmocele with the aid of a bending probe.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- uterine isthmocele status post laparoscopic or robotic metroplasty
Key inclusion criteria (2 listed)
- > 20 years of women
- uterine isthmocele status post laparoscopic or robotic metroplasty with a bent uterine sound
Key exclusion criteria (1 listed)
- Those underwent traditional open surgery.
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 |
|---|---|---|
| C/Slaparoscopic or robotic metroplasty | Procedure or surgery | – |
Primary outcome
Change of prolonged menstrual bleeding condition
Time frame: 10 years
Symptoms improvement and perioperative complications
1 secondary outcome
Change of scar defect size
Time frame: 10 years
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 17 Aug 2022.
- 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 Laparoscopic or Robotic Metroplasty, 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 17 Aug 2022. 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?
Change of prolonged menstrual bleeding condition (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 17 Aug 2022.