NCT02671253

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

January 25, 2016

Last Update Submit

January 31, 2016

Conditions

Uterine MyomectomyGeneticsQuality of LifeGynecologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Quality of life measured by a validated questionnaire (UFS-QOL)

    UFS-QOL: Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire

    Two years

Secondary Outcomes (1)

  • Pregnancy rate after myomectomy, data collected with questionnaire

    Five years

Interventions

MyomectomyPROCEDURE

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women at age under 46 years undergoing myomectomy.

You may qualify if:

  • Uterine leiomyoma
  • Seeking for surgery

You may not qualify if:

  • Language proficiency in Finnish, Swedish or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kätilöopisto Maternity Hospital, Helsinki University hospital

Helsinki, Huch, 00029, Finland

RECRUITING

MeSH Terms

Interventions

Uterine Myomectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Päivi I Pakarinen, MD PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Päivi I Pakarinen, MD PhD

CONTACT

358504271531paivi.pakarinen@hus.fi

Anna K Äyräväinen, MD

CONTACT

35894711anna.ayravainen@helsinki.fi

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 2, 2016

Study Start

October 1, 2015

Primary Completion

January 1, 2018

Last Updated

February 2, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)