Abnormalities UterineNCT06311812
Retrospective Review on Uterovaginal Anomalies
An observational study of Abnormalities Uterine and Vaginal Abnormality, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Abnormalities Uterine, Vaginal Abnormality
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2024to 14 Feb 2025
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: All patients who attended the Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital with the diagnosis of uterovaginal anomaly between 1.1.2000 and 31.12.2023.
Who may be able to join
- All patients who attended the Prince of Wales Hospital with the diagnosis of uterovaginal anomaly since 2000
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Yat Ka YEUNG, 85255699567, estheryeung@cuhk.edu.hk
About this study
Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis.
Read the detailed description
Uterovaginal anomalies are congenital malformations of the female reproductive tract, including hymenal, vaginal, cervical and uterine anomalies. The incidence could be as high as 7% in females1. These anomalies can occur alone or in association with other anomalies such as renal anomalies.
There could be variable consequences from these malformations, some are asymptomatic while some may have various symptoms.
It is important to be aware that obstructive uterovaginal anomalies, examples including imperforated hymen and obstructive hemivagina and ipsilateral renal anomaly (also known as OHVIRA), may present after puberty, with symptoms including amenorrhoea, dysmenorrhea, pelvic pain etc. These are conditions that should be managed. Patient may require interventions. Surgery is the principal management for obstructive anomalies, dependent on the types of obstruction. Types of surgeries ranges from simple surgical procedures to complex surgeries that require multidisciplinary input.
Post-operatively patients should be offered follow up for monitoring in view of the risk of stenosis that may require ongoing dilation or additional surgical management.
There are limited studies on the post-operative outcomes for uterovaginal anomalies, so this study aims at reviewing and comparing the different outcomes after initial surgery.
This is a retrospective observational study. Electronic and paper clinical records of all patients who attended the Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital with the diagnosis of uterovaginal anomaly will be reviewed, data collected will be input and analyzed using different statistical analysis tools. Data between 1.1.2000 and 31.12.2023 will be reviewed retrospectively. No human subject will be recruited.
The aim of the study is to reviewing and comparing the different outcomes after surgery for patients who had uterovaginal anomalies
- Conditions
- Abnormalities Uterine, Vaginal Abnormality
- Medical subject headings
- Uterine Anomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of re-stenosis
Patient record will be reviewed. Number of patients need re-stenosis after surgical treatment for obstructive uterovaginal anomalies will be counted.
Measured: 1 year after operation
Incidence of re-operation
Patient record will be reviewed. Number of patients need re-operation after surgical treatment for obstructive uterovaginal anomalies will be counted.
Measured: 1 year after operation
Number of patients with normal menstruation after operation
Menstruation status will be reviewed in post-operation follow up. Number of patients with normal menstruation after surgical treatment for obstructive uterovaginal anomalies will be counted.
Measured: 1 year after operation
Number of patients with sexual intercourse after operation
Sexual status will be asked in post-operation follow up. Number of patients with sexual intercourse after surgical treatment for obstructive uterovaginal anomalies will be counted.
Measured: 1 year after operation
Number of patients with post-operative infection
Patient record will be reviewed. Number of patients with post-operative infection will be counted.
Measured: 1 year after operation
Number of patients with pregnancy after operation
Pregnancy status will be reviewed. Number of patients with ultrasound confirmed pregnancy after operation will be counted.
Measured: 1 year after operation
Secondary outcomes (2)
Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies
Background demographics including age at diagnosis, age at operation, difference in age between menarche and diagnosis/ operation, history of previous abdominal or reproductive tract surgery, menstrual cycle will be reviewed.
Categorical data will be analyzed with Chi square or Fisher's exact test. Continuous data will be analyzed with t test and ANOVA test. The significance level is set at 0.05.
Measured: 1 year after operation
Number of participants with Pre-operative factors affecting post-operative outcomes
Pre-operative factors including presentation at diagnosis, laterality of hematocolpos, thickness and size of septum, distance of septum to perineum, obstructed longitudinal septum axis and the type of renal anomaly will be reviewed.
Categorical data will be analyzed with Chi square or Fisher's exact test. Continuous data will be analyzed with t test and ANOVA test. The significance level is set at 0.05.
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024
- Primary completion14 Feb 2025 (estimated)
- Study completion14 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormalities UterineStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG Yat Ka ESTHER, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311812
- Sponsor's protocol ID
- CREC 2023.683
- Status last verified
- May 2024
- First submitted
- 18 Jan 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review on Uterovaginal Anomalies
- ClinicalTrials.gov ID
- NCT06311812
- Acronym / sponsor ID
- CREC 2023.683
- Conditions
- Abnormalities Uterine, Vaginal Abnormality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 14 Feb 2025 (estimated)
- First posted
- 15 Mar 2024 (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.
Review of surgical outcomes of patient who have undergone surgery for uterovaginal anomalies. Case notes of patients would be reviewed and data would be gathered for statistical analysis.
Detailed description
Uterovaginal anomalies are congenital malformations of the female reproductive tract, including hymenal, vaginal, cervical and uterine anomalies. The incidence could be as high as 7% in females1. These anomalies can occur alone or in association with other anomalies such as renal anomalies.
There could be variable consequences from these malformations, some are asymptomatic while some may have various symptoms.
It is important to be aware that obstructive uterovaginal anomalies, examples including imperforated hymen and obstructive hemivagina and ipsilateral renal anomaly (also known as OHVIRA), may present after puberty, with symptoms including amenorrhoea, dysmenorrhea, pelvic pain etc. These are conditions that should be managed. Patient may require interventions. Surgery is the principal management for obstructive anomalies, dependent on the types of obstruction. Types of surgeries ranges from simple surgical procedures to complex surgeries that require multidisciplinary input.
Post-operatively patients should be offered follow up for monitoring in view of the risk of stenosis that may require ongoing dilation or additional surgical management.
There are limited studies on the post-operative outcomes for uterovaginal anomalies, so this study aims at reviewing and comparing the different outcomes after initial surgery.
This is a retrospective observational study. Electronic and paper clinical records of all patients who attended the Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital with the diagnosis of uterovaginal anomaly will be reviewed, data collected will be input and analyzed using different statistical analysis tools. Data between 1.1.2000 and 31.12.2023 will be reviewed retrospectively. No human subject will be recruited.
The aim of the study is to reviewing and comparing the different outcomes after surgery for patients who had uterovaginal anomalies
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who attended the Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital with the diagnosis of uterovaginal anomaly between 1.1.2000 and 31.12.2023.
Key inclusion criteria (1 listed)
- All patients who attended the Prince of Wales Hospital with the diagnosis of uterovaginal anomaly since 2000
Key exclusion criteria (1 listed)
- Nil
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
Incidence of re-stenosis
Time frame: 1 year after operation
Patient record will be reviewed. Number of patients need re-stenosis after surgical treatment for obstructive uterovaginal anomalies will be counted.
Incidence of re-operation
Time frame: 1 year after operation
Patient record will be reviewed. Number of patients need re-operation after surgical treatment for obstructive uterovaginal anomalies will be counted.
Number of patients with normal menstruation after operation
Time frame: 1 year after operation
Menstruation status will be reviewed in post-operation follow up. Number of patients with normal menstruation after surgical treatment for obstructive uterovaginal anomalies will be counted.
Number of patients with sexual intercourse after operation
Time frame: 1 year after operation
Sexual status will be asked in post-operation follow up. Number of patients with sexual intercourse after surgical treatment for obstructive uterovaginal anomalies will be counted.
Number of patients with post-operative infection
Time frame: 1 year after operation
Patient record will be reviewed. Number of patients with post-operative infection will be counted.
Number of patients with pregnancy after operation
Time frame: 1 year after operation
Pregnancy status will be reviewed. Number of patients with ultrasound confirmed pregnancy after operation will be counted.
2 secondary outcomes
Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies
Time frame: 1 year after operation
Number of participants with Pre-operative factors affecting post-operative outcomes
Time frame: 1 year after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Related trials for Abnormalities Uterine
RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
RecruitingPhase 1/2
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Advanced Cancer, Metastatic Cancer
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.
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 Abnormalities Uterine and Vaginal Abnormality, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 May 2024. 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 Hong Kong. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of re-stenosis (time frame: 1 year after operation). The study lists 6 primary outcomes in all. 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 May 2024.