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NCT02671253 Clinical Trial

Myomectomies:Tumor Characteristics and Clinical Implications

Quality of Life Clinical Trial

Official title:
Myomectomies:Tumor Characteristics and Clinical Implications

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02671253
Other study ID # 24/13703/03/2015
Secondary ID
Status Recruiting
Phase N/A
First received January 25, 2016
Last updated January 31, 2016
Start date October 2015

Study information
Verified date January 2016
Source Helsinki University Central Hospital
Contact Päivi I Pakarinen, MD PhD
Phone 358504271531
Email paivi.pakarinen@hus.fi
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Uterine leiomyoma

- Seeking for surgery

Exclusion Criteria:

- Language proficiency in Finnish, Swedish or English

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Myomectomy
The patient series consists of consecutive patients scheduled for elective laparotomic, traditional laparoscopic or robotic assisted laparoscopic myomectomy. The surgical method is selected based on clinician´s preference.

Locations
Country Name City State
Finland Kätilöopisto Maternity Hospital, Helsinki University hospital Helsinki Huch

Sponsors (2)
Lead Sponsor Collaborator
Helsinki University Central Hospital Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life measured by a validated questionnaire (UFS-QOL) UFS-QOL: Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire Two years No
Secondary Pregnancy rate after myomectomy, data collected with questionnaire Five years No
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