Quality of Life After Hysterectomy (AdenoQOL)

NCT ID: NCT04791033

Last Updated: 2024-04-19

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

ACTIVE_NOT_RECRUITING

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-18

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenomyosis Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adenomyosis

Patients with adenomyosis

Hysterectomy

Intervention Type PROCEDURE

Elective procedure with hysterectomy due to benign gynecological condition

Other benign gynecological conditions

Patients with other benign gynecological conditions (i.e: myomas, endometriosis).

Hysterectomy

Intervention Type PROCEDURE

Elective procedure with hysterectomy due to benign gynecological condition

Interventions

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Hysterectomy

Elective procedure with hysterectomy due to benign gynecological condition

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Omtvedt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marianne Omtvedt, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Tina Tellum, PhD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Marianne Omtvedt

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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213906

Identifier Type: -

Identifier Source: org_study_id

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