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临床试验/NCT06311812
NCT06311812招募中不适用

Retrospective Review on Uterovaginal Anomalies

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Incidence of re-operation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Incidence of re-operation

时间窗: 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 sexual intercourse after operation

时间窗: 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

时间窗: 1 year after operation

Patient record will be reviewed. Number of patients with post-operative infection will be counted.

Incidence of re-stenosis

时间窗: 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.

Number of patients with normal menstruation after operation

时间窗: 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 pregnancy after operation

时间窗: 1 year after operation

Pregnancy status will be reviewed. Number of patients with ultrasound confirmed pregnancy after operation will be counted.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YEUNG Yat Ka ESTHER

Clinical Tutor (honorary)

Chinese University of Hong Kong

研究点 (1)

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