Quality of Life After Hysterectomy (AdenoQOL)

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Brief Title

Quality of Life After Hysterectomy (AdenoQOL)

Official Title

Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions

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.
    



Study Type

Observational


Primary Outcome

The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain

Secondary Outcome

 The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales

Condition

Adenomyosis

Intervention

Hysterectomy

Study Arms / Comparison Groups

 Adenomyosis
Description:  Patients with adenomyosis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

218

Start Date

March 18, 2021

Completion Date

December 2030

Primary Completion Date

March 21, 2022

Eligibility 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
      

Gender

Female

Ages

18 Years - 52 Years

Accepts Healthy Volunteers

No

Contacts

Marianne Omtvedt, MD, 004792441473, [email protected]

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT04791033

Organization ID

213906


Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital


Study Sponsor

Marianne Omtvedt, MD, Principal Investigator, Oslo University Hospital


Verification Date

March 2021