Prevalence of Intrauterine Adhesions After Myomectomy

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 undergoing laparoscopic or laparotomic myomectomy were considered eligible and were approached for enrollment. Women who provided informed consent were included in the study and 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.

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Key information

Conditions

Myoma;Uterus Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Ospedale "Filippo Del Ponte"

Varese, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic hysteroscopy

Diagnostic Test

Diagnostic hysteroscopy performed three months after myomectomy in an office setting using a vaginoscopic approach, without cervical dilatation, with a 4.3 mm outer sheath hysteroscope (BETTOCCHI Office Hysteroscope size 5; Karl Storz, Tuttlingen, Germany). Normal saline solution was used as the uterine distension medium.

Primary outcomes

Prevalence of intrauterine adhesions

Time frame: 3 months after myomectomy

Proportion of enrolled women with intrauterine adhesions identified by office diagnostic hysteroscopy. Intrauterine adhesions were defined according to the European Society of Gynecological Endoscopy (ESGE) criteria.

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Collaborators

University of Miami

Registry information

Official study title

Prevalence of Intrauterine Adhesions After Myomectomy: A Prospective Multicenter Observational Study

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jul 23, 2019
Registry last updated: Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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