- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06311812
Retrospective Review on Uterovaginal Anomalies
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who attended the Prince of Wales Hospital with the diagnosis of uterovaginal anomaly since 2000
Exclusion Criteria:
- Nil
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year after operation
|
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.
|
1 year after operation
|
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.
|
1 year after operation
|
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.
|
1 year after operation
|
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.
|
1 year after operation
|
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.
|
1 year after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies
Time Frame: 1 year after operation
|
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. |
1 year after operation
|
Number of participants with Pre-operative factors affecting post-operative outcomes
Time Frame: 1 year after operation
|
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. |
1 year after operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC 2023.683
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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