Prevalence of Intrauterine Adhesions After Myomectomy

NCT04030273 | Completed

• 1 other identifier: ADAM-1
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myoma;Uterus

Keywords

Diagnostic hysteroscopy; Fertility; Intrauterine adhesions; Myomectomy; Uterine fibroids

Outcome Measures

Primary Outcomes (1)

• Prevalence of intrauterine adhesions

  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.

  3 months after myomectomy

Study Arms (2)

Laparotomic myomectomy

Women undergoing uterine myomectomy by open surgery (laparotomy).

Diagnostic Test: Diagnostic hysteroscopy

Laparoscopic myomectomy

Women undergoing uterine myomectomy by laparoscopy.

Diagnostic Test: Diagnostic hysteroscopy

Interventions

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.

Laparoscopic myomectomy; Laparotomic myomectomy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: 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 underwent laparoscopic or laparotomic myomectomy were considered eligible.

You may qualify if:

• Diagnosis of one or more uterine myomas
• Desire to preserve fertility/uterus
• Myomectomy (by laparotomy or laparoscopy)

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead
• University of Miami: collaborator

Study Sites (1)

Ospedale "Filippo Del Ponte"

Varese, Italy

Location

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: 35168241 RESULT

MeSH Terms

Conditions

Myofibroma; Gynatresia; Leiomyoma

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jose Carugno

  University of Miami

  STUDY DIRECTOR

• Andrea Tinelli

  Vito Fazzi Hospital

  STUDY CHAIR

• Antonio Simone Laganà

  Università degli Studi dell'Insubria

  STUDY CHAIR

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 21, 2020
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)