Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myomectomies:Tumor Characteristics and Clinical Implications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671253
Recruitment Status : Unknown
Verified January 2016 by Päivi Päkarinen, Helsinki University Central Hospital.
Recruitment status was:  Recruiting
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Collaborator:
University of Helsinki
Information provided by (Responsible Party):
Päivi Päkarinen, 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.


Condition or disease Intervention/treatment
Uterine Myomectomy Genetics Quality of Life Gynecologic Surgical Procedures Procedure: Myomectomy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myomectomies:Tumor Characteristics and Clinical Implications
Study Start Date : October 2015
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Quality of life measured by a validated questionnaire (UFS-QOL) [ Time Frame: Two years ]
    UFS-QOL: Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire


Secondary Outcome Measures :
  1. Pregnancy rate after myomectomy, data collected with questionnaire [ Time Frame: Five years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women at age under 46 years undergoing myomectomy.
Criteria

Inclusion Criteria:

  • Uterine leiomyoma
  • Seeking for surgery

Exclusion Criteria:

  • Language proficiency in Finnish, Swedish or English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671253


Contacts
Layout table for location contacts
Contact: Päivi I Pakarinen, MD PhD 358504271531 paivi.pakarinen@hus.fi
Contact: Anna K Äyräväinen, MD 35894711 anna.ayravainen@helsinki.fi

Locations
Layout table for location information
Finland
Kätilöopisto Maternity Hospital, Helsinki University hospital Recruiting
Helsinki, Huch, Finland, 00029
Contact: Päivi I Pakarinen, MD PhD    358504271531    paivi.pakarinen@hus.fi   
Contact: Anna K Äyräväinen, MD    35894711    anna.ayravainen@helsinki.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
University of Helsinki
Investigators
Layout table for investigator information
Principal Investigator: Päivi I Pakarinen, MD PhD Helsinki University Central Hospital
Layout table for additonal information
Responsible Party: Päivi Päkarinen, MD PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02671253    
Other Study ID Numbers: 24/13703/03/2015
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No