Retrospective Review on Uterovaginal Anomalies

Vaginal Abnormality Clinical Trial

Official title:

Retrospective Review on Uterovaginal Anomalies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311812
• Other study ID #: CREC 2023.683
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: February 14, 2025

Study information

• Verified date: May 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 14, 2025
• Est. primary completion date: February 14, 2025
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Nil

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vaginal Abnormality

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year after operation
Primary	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.	1 year after operation
Primary	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.	1 year after operation
Primary	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.	1 year after operation
Primary	Number of patients with post-operative infection	Patient record will be reviewed. Number of patients with post-operative infection will be counted.	1 year after operation
Primary	Number of patients with pregnancy after operation	Pregnancy status will be reviewed. Number of patients with ultrasound confirmed pregnancy after operation will be counted.	1 year after operation
Secondary	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.	1 year after operation
Secondary	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.	1 year after operation