Clinical trial NCT04030273: Prevalence of Intrauterine Adhesions After Abdominal Myomectomy
Official title: Prevalence of Intrauterine Adhesions After Abdominal Myomectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myoma;Uterus
Keywords: Intrauterine adhesions
Abdominal myomectomy
Hysteroscopy
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2019-07-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients from 18 to 45 years of age with the diagnosis of uterine fibroids, wish to preserve fertility/uterus, not candidates for hysteroscopic myomectomy who are scheduled to undergo laparoscopic, robotic assisted or open myomectomy.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intrauterine adhesions
timeFrame: 3 months after myomectomy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Jose Carugno
role: STUDY_DIRECTOR
affiliation: Vito Fazzi Hospital
name: Andrea Tinelli
role: STUDY_CHAIR
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà
role: STUDY_CHAIR
References:
citation: Lagana AS, Garzon S, Dababou S, Uccella S, Medvediev M, Pokrovenko D, Babunashvili EL, Buyanova SN, Schukina NA, Shcherbatykh Kaschchuk MG, Kosmas I, Licchelli M, Panese G, Tinelli A. Prevalence of Intrauterine Adhesions after Myomectomy: A Prospective Multicenter Observational Study. Gynecol Obstet Invest. 2022;87(1):62-69. doi: 10.1159/000522583. Epub 2022 Feb 15.