Prevalence of Intrauterine Adhesions After Myomectomy

Università degli Studi dell'Insubria

Status: Completed

Conditions: Myoma;Uterus

Treatments: Diagnostic Test: Diagnostic hysteroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04030273

ADAM-1

Details and patient eligibility

About

This prospective, multicenter, observational study evaluated the prevalence of intrauterine adhesions after laparoscopic or laparotomic myomectomy and investigated clinical and surgical factors associated with their occurrence. Consecutive women who underwent laparoscopic or laparotomic myomectomy were considered eligible and were approached for enrollment. Women who provided informed consent were included in the study. All included women underwent myomectomy and postoperative management according to routine clinical practice. All enrolled women underwent office diagnostic hysteroscopy three months after surgery to assess the presence of intrauterine adhesions. Clinical characteristics, surgical details of the myomectomy, and hysteroscopic findings were prospectively collected in an anonymized database.

Enrollment: 62 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of one or more uterine myomas
• Desire to preserve fertility/uterus
• Myomectomy (by laparotomy or laparoscopy)

Exclusion criteria

• Adults unable to consent
• Pregnant women
• Prisoners
• History of previous intrauterine procedures such as dilation and curettage
• History of known intrauterine adhesions
• History of documented pelvic inflammatory disease
• History of endometritis (acute or chronic)
• Hysteroscopic myomectomy

Trial design

62 participants in 2 patient groups

Laparotomic myomectomy

Description:

Women undergoing uterine myomectomy by open surgery (laparotomy).

Treatment:

Diagnostic Test: Diagnostic hysteroscopy

Laparoscopic myomectomy

Description:

Women undergoing uterine myomectomy by laparoscopy.

Treatment:

Diagnostic Test: Diagnostic hysteroscopy