Prevalence of Intrauterine Adhesions After Abdominal Myomectomy
1 other identifier
observational
150
0 countries
N/A
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.
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedSeptember 30, 2021
September 1, 2021
1 year
July 19, 2019
September 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Open (laparotomic) myomectomy
Women undergoing uterine myomectomy by open surgery (laparotomy).
Laparoscopic myomectomy
Women undergoing uterine myomectomy by laparoscopy.
Robotic myomectomy
Women undergoing uterine myomectomy by robotic surgery.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Diagnosis of one or more uterine myomas
- Desire to preserve fertility/uterus
- Myomectomy (by laparotomy, laparoscopy or robotic approach).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Università degli Studi dell'Insubrialead
- University of Miamicollaborator
Related Publications (1)
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.
PMID: 35168241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jose Carugno
University of Miami
- STUDY CHAIR
Andrea Tinelli
Vito Fazzi Hospital
- STUDY CHAIR
Antonio Simone Laganà
Università degli Studi dell'Insubria
Central Study Contacts
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
July 19, 2019
First Posted
July 23, 2019
Study Start
January 1, 2022
Primary Completion
January 1, 2023
Study Completion
January 1, 2024
Last Updated
September 30, 2021
Record last verified: 2021-09