Prevalence of Intrauterine Adhesions After Abdominal Myomectomy

NCT ID: NCT04030273

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2024-01-31

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.

Conditions

Myoma;Uterus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Open (laparotomic) myomectomy

Women undergoing uterine myomectomy by open surgery (laparotomy).

Diagnostic hysteroscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Laparoscopic myomectomy

Women undergoing uterine myomectomy by laparoscopy.

Diagnostic hysteroscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Robotic myomectomy

Women undergoing uterine myomectomy by robotic surgery.

Diagnostic hysteroscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Antonio Simone Laganà

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Carugno

Role: STUDY_DIRECTOR

University of Miami

Andrea Tinelli

Role: STUDY_CHAIR

Vito Fazzi Hospital

Antonio Simone Laganà

Role: STUDY_CHAIR

Università degli Studi dell'Insubria

Central Contacts

Antonio Simone Laganà, M.D.

Role: CONTACT

antoniosimone.lagana@uninsubria.it

+393296279579

References

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.

Reference Type: DERIVED

PMID: 35168241 (View on PubMed)

Other Identifiers

ADAM-1

Identifier Type: -

Identifier Source: org_study_id