Clinical trial NCT06311812: Retrospective Review on Uterovaginal Anomalies
Official title: Retrospective Review on Uterovaginal Anomalies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abnormalities Uterine
Vaginal Abnormality
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* All patients who attended the Prince of Wales Hospital with the diagnosis of uterovaginal anomaly since 2000

Exclusion Criteria:

* Nil

Primary outcomes:
measure: Incidence of re-stenosis
timeFrame: 1 year after operation
measure: Incidence of re-operation
timeFrame: 1 year after operation
measure: Number of patients with normal menstruation after operation
timeFrame: 1 year after operation
measure: Number of patients with sexual intercourse after operation
timeFrame: 1 year after operation
measure: Number of patients with post-operative infection
timeFrame: 1 year after operation
measure: Number of patients with pregnancy after operation
timeFrame: 1 year after operation
Secondary outcomes:
measure: Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies
timeFrame: 1 year after operation
measure: Number of participants with Pre-operative factors affecting post-operative outcomes
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: