Prevalence of Intrauterine Adhesions After Myomectomy

August 13, 2026 updated by: Antonio Simone Laganà, Università degli Studi dell'Insubria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy
        • Ospedale "Filippo Del Ponte"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laparoscopic myomectomy
Women undergoing uterine myomectomy by laparoscopy.
Diagnostic test: Diagnostic hysteroscopy
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.
Laparotomic myomectomy
Women undergoing uterine myomectomy by open surgery (laparotomy).
Diagnostic test: Diagnostic hysteroscopy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after myomectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Collaborators

University of Miami

Investigators

  • Study Director: Jose Carugno, University of Miami
  • Study Chair: Andrea Tinelli, Vito Fazzi Hospital
  • Study Chair: Antonio Simone Laganà, Università degli Studi dell'Insubria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Actual)

March 29, 2021

Study Completion (Actual)

March 29, 2021

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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