Prevalence of Intrauterine Adhesions After Abdominal Myomectomy

Myoma;Uterus Clinical Trial

Official title:

Prevalence of Intrauterine Adhesions After Abdominal Myomectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04030273
• Other study ID #: ADAM-1
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: January 2024

Study information

• Verified date: September 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: +393296279579
• Email: antoniosimone.lagana[@]uninsubria.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Uterine fibroids are the most common benign tumors of the genital organs of women of childbearing age. Literature data show that more than 75% of women have fibroids.Symptomatic fibroids account for approximately over 200,000 hysterectomies and 50,000 myomectomies annually in the United States. Fibroids have a major impact on fertility, with significant adverse effect on implantation rate and spontaneous abortion rates when compared with infertile women without fibroids. The definitive treatment for uterine fibroids in a fertile patient is surgical excision. Although usually effective, myomectomy is not a risk-free operation, since the surgical procedure can cause mechanical infertility and can be associated with infection, injury to adjacent tissues, hemorrhage and need to convert to hysterectomy. A not often mentioned consequence of myomectomy is post-operative intrauterine adhesion formation. It has been reported that 50% of women undergoing open myomectomy are found to have intrauterine adhesions diagnosed by hysteroscopy performed 3 months after surgery. Such a high prevalence of intrauterine adhesions after open myomectomy is unexpected, however only few studies have addressed this topic.

It is accepted that injury to the endometrium is generally considered to be the primary causative factor for the development of intrauterine adhesions. The reason for such a high incidence of intrauterine adhesions after open myomectomy is unclear. It is speculated that infection or in adverted closure of the uterine cavity may play a role in intrauterine adhesion formation. The relationship between the number of fibroids removed and the risk of adhesions suggests a traumatic etiology. In the preservation of the uterus for the purpose of fertility, it is essential to also understand the impact of myomectomy on the endometrium. Currently no guideline recommends in office hysteroscopy as follow-up after myomectomy. The purpose of the present study is to evaluate the frequency of uterine adhesions following myomectomy and the impact of number, size and location of the fibroids as well as intraoperative breach of the endometrial cavity at the time of the myomectomy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosis of one or more uterine myomas

• Desire to preserve fertility/uterus

• Myomectomy (by laparotomy, laparoscopy or robotic approach).

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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus
• Tissue Adhesions

Intervention

Diagnostic Test:
• Diagnostic hysteroscopy
Diagnostic hysteroscopy performed in outpatient setting, using "no touch" vaginoscopy technique with a 2.9 mm 30-degree rigid hysteroscope with a single inflow sheet using normal saline as distention media.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria	University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrauterine adhesions	Presence of intrauterine adhesion, following the American Fertility Society classification (Fertil Steril. 1988;49:944-955.) in mild, moderate, or severe.	3 months after myomectomy