Myomectomies:Tumor Characteristics and Clinical Implications

NCT ID: NCT02671253

Last Updated: 2016-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Brief Summary

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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

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Conditions

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Uterine Myomectomy Genetics Quality of Life Gynecologic Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Uterine leiomyoma
* Seeking for surgery

Exclusion Criteria

* Language proficiency in Finnish, Swedish or English
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Päivi Päkarinen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Päivi I Pakarinen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Kätilöopisto Maternity Hospital, Helsinki University hospital

Helsinki, Huch, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Päivi I Pakarinen, MD PhD

Role: CONTACT

358504271531

Anna K Äyräväinen, MD

Role: CONTACT

Facility Contacts

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Päivi I Pakarinen, MD PhD

Role: primary

358504271531

Anna K Äyräväinen, MD

Role: backup

Other Identifiers

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24/13703/03/2015

Identifier Type: -

Identifier Source: org_study_id

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