NCT06311812

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2025

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

January 18, 2024

Last Update Submit

May 2, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Background demographics affecting post-operative outcomes for patients with uterovaginal anomalies

    1 year after operation

  • Number of participants with Pre-operative factors affecting post-operative outcomes

    1 year after operation

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Uterine Anomalies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Tutor (honorary)

Study Record Dates

First Submitted

January 18, 2024

First Posted

March 15, 2024

Study Start

April 1, 2024

Primary Completion

February 14, 2025

Study Completion

February 14, 2025

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations