Quality of Life After Hysterectomy (AdenoQOL)

NCT04791033 | Active Not Recruiting

• 1 other identifier: 213906
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis; Quality of Life

Keywords

Hysterectomy; Sexual Health; Adenomyosis

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Secondary Outcomes (4)

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

  5 years

• The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales

  5 years

• The impact of hysterectomy on sexual function assessed by FSFI

  1 year

• The impact of hysterectomy on sexual function assessed by FSFI

  5 years

Study Arms (2)

Adenomyosis

Patients with adenomyosis

Procedure: Hysterectomy

Other benign gynecological conditions

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

Procedure: Hysterectomy

Interventions

Hysterectomy PROCEDURE

Elective procedure with hysterectomy due to benign gynecological condition

Adenomyosis; Other benign gynecological conditions

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• Not able to communicate in Norwegian or English

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Marianne Omtvedt

Oslo, Norway

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marianne Omtvedt, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Tina Tellum, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: March 18, 2021
• Primary Completion: October 30, 2022
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

NO (1)