A Prospective Multicenter Study regarding the Efficacy and Safety ofAdenomyomectomy

JRCT ID: jRCT1030240061

Registered date:07/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adenomyosis
• Date of first enrollment: 07/05/2024
• Target sample size: 54
• Study type: Interventional
• Intervention(s): Perform adenomyomectomy

Outcome(s)

• Primary Outcome: Change in the total score of dysmenorrhea after 3 months

Secondary Outcome

1) Change in pain score on the dysmenorrhea score at 3 and 9 months.
2) Change in pain medication usage score on the dysmenorrhea score at 3 and 9 months.
3) Complete disappearance rate of the dysmenorrhea score at 3 and 9 months.
4) Change in the total score of the dysmenorrhea score at 9 months.
5) Change in uterine volume on MRI.
6) Change in pain (NRS 0-10) at 3 and 9 months due to dysmenorrhea.
7) Change in pelvic pain (NRS 0-10) at 3 and 9 months due to adenomyosis.
8) Change in non-menstrual pelvic pain (NRS 0-10) at 3 and 9 months.
9) Change in MMAS at 3 and 9 months.
10) Surgical outcomes in adenomyomectomy (surgical time, blood loss, surgical complications, extent of adenomyosis lesion excision, and specimen weight).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Those who have received a diagnosis of uterine adenomyosis through MRI testing.
2) Those who wish to preserve their fertility.
3) Those who are 18 years of age or older at the time of obtaining consent.
4) Those who are pre-menopausal and still experience regular menstrual cycles.
5) Those for whom existing drug therapy for uterine adenomyosis cannot be conducted or has not resulted in significant symptom improvement.
6) Those with a combined Menstrual Difficulty Score of 3 or higher.
7) Those who are suitable candidates for surgical removal of uterine adenomyosis lesions.
8) Those who have received adequate explanation about participation in this study, have a thorough
understanding, and have provided written consent of their own free will.

Exclude criteria

1) Those with Grade 3 or higher complications according to CTCAE v5.0.
2) Those with unexplained abnormal genital bleeding.
3) Those with indicated uterine malignancies requiring treatment.
4) Those who are pregnant or may be pregnant.
5) Those deemed unsuitable for participation in this study by the Principal Investigator or Co-Investigator.

Related Information

• Primary Sponsor: Hirota Yasushi