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Quality of Life After Hysterectomy (AdenoQOL)

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: NCT04791033
Recruitment Status : Active, not recruiting
First Posted : March 10, 2021
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Marianne Omtvedt, Oslo University Hospital

Study Description
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Brief Summary:

Adenomyosis is a disease where ectopic endometrial-like glands affect the muscular wall of the uterus. About 70% of women affected by adenomyosis suffer from dysmenorrhea and menorrhagia. A levonorgestrel-releasing intrauterine device (LNG-IUD) is the first-choice treatment of adenomyosis, but is not always sufficiently effective in all women. Those women often end up removing the uterus (hysterectomy).

Hysterectomy is clinically regarded to be an efficient and final treatment of adenomyosis, but pelvic pain may also prevail after removal of the uterus. This study aimes to investigate the short - and long-term impact of hysterectomy on quality of life (QOL) and sexual function in women with adenomyosis, and further to evaluate if there is any difference compared to women that are removing their uterus due to other benign gynecological conditions.


Condition or disease Intervention/treatment
Adenomyosis Quality of Life Procedure: Hysterectomy

Study Design
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Study Type : Observational
Estimated Enrollment : 218 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions
Actual Study Start Date : March 18, 2021
Actual Primary Completion Date : October 30, 2022
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Adenomyosis
Patients with adenomyosis
 Procedure: Hysterectomy
Elective procedure with hysterectomy due to benign gynecological condition
Other benign gynecological conditions
Patients with other benign gynecological conditions (i.e: myomas, endometriosis).
 Procedure: Hysterectomy
Elective procedure with hysterectomy due to benign gynecological condition


Outcome Measures
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Primary Outcome Measures :
  1. The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain [ Time Frame: 1 year ]
    The Short Form Health Survey (SF-36) measures eight sub scales including bodily pain (BP) which in this study is used as primary outcome. The scales ranges from 0-100, a higher score indicates a better quality of life.


Secondary Outcome Measures :
  1. The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales [ Time Frame: 5 years ]
    The Short Form Health Survey (SF-36) measures eight subscales. In this study seven sub scales is used as secondary outcomes: Physical functioning (PF), role physical (RP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The scales ranges from 0-100, a higher score indicates a better quality of life.

  2. The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales [ Time Frame: 5 years ]
    The Short Form Health Survey (SF-36) measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The scales ranges from 0-100, a higher score indicates a better quality of life.

  3. The impact of hysterectomy on sexual function assessed by FSFI [ Time Frame: 1 year ]
    The Female Sexual Function Index (FSFI) use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning. To score the measure the sum of each domain score (sexual desire, arousal, lubrication, orgasm, satisfaction and pain) is multiplied by a domain factor and summed to derive a total FSFI score.

  4. The impact of hysterectomy on sexual function assessed by FSFI [ Time Frame: 5 years ]
    The Female Sexual Function Index (FSFI) use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning. To score the measure the sum of each domain score (sexual desire, arousal, lubrication, orgasm, satisfaction and pain) is multiplied by a domain factor and summed to derive a total FSFI score.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A consecutive sample of women that are scheduled for hysterectomy at the study site, who fulfill eligibility criteria, are invited to participate
Criteria

Inclusion Criteria:

  • Premenopausal status defined by having had menstruation within the last 12 months, or age < 50 years if amenorrhea due to hormonal treatment
  • Hysterectomy planned due to a benign condition
  • Able to communicate in Norwegian or English
  • Electronic consent given

Exclusion Criteria:

  • Age < 18 years, postmenopausal status or no menstrual bleeding for the last 12 months
  • Hysterectomy as part of female-to-male transition
  • Pelvic organ prolapse as an indication for hysterectomy
  • Gynecological cancer suspected at the time of inclusion
  • Not able to communicate in Norwegian or English
Contacts and Locations
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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): NCT04791033


Locations
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Norway
Marianne Omtvedt
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Marianne Omtvedt, MD Oslo University Hospital
Study Director: Tina Tellum, PhD Oslo University Hospital
More Information
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Responsible Party: Marianne Omtvedt, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04791033    
Other Study ID Numbers: 213906
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share the values of the quality of life data.
Supporting Materials: Study Protocol
Time Frame: The data is planned to be made available within a year after the publication of all results.
Access Criteria: Access will be granted upon request and evaluation of the intended use of the data. The intended use should primarily gain improved patient care and research into quality of life after hysterectomy and a detailed protocol has to be submitted.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marianne Omtvedt, Oslo University Hospital:
Hysterectomy
Sexual Health
Adenomyosis
Additional relevant MeSH terms:
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Adenomyosis
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases