Myomectomies:Tumor Characteristics and Clinical Implications

• Conditions: Genetics; Uterine Myomectomy; Gynecologic Surgical Procedures; Quality of Life

• Registration Number: NCT02671253
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

This project focuses on myomectomy patients in reproductive age. The aim is to study both the molecular characteristics of uterine fibroids and to characterize the clinical effects of surgical treatment.

Patient series is mainly retrospective and consists of individuals who have undergone myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the investigators have started a prospective sample collection starting in October 2015, collecting samples from myomectomies.

Clinical data sources include medical records, specific questionnaires and a quality of life -questionnaire filled by patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-31
• Last Update Submitted: 2016-01-31
• Study First Posted: 2016-02-02
• Last Update Posted: 2016-02-02
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Uterine leiomyoma
• Seeking for surgery

Exclusion Criteria

• Language proficiency in Finnish, Swedish or English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measured by a validated questionnaire (UFS-QOL)	Two years	UFS-QOL: Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate after myomectomy, data collected with questionnaire	Five years

Trial Locations

Locations (1)

Kätilöopisto Maternity Hospital, Helsinki University hospital; 🇫🇮 Helsinki, Huch, Finland