Myoma;UterusNCT04030273
Prevalence of Intrauterine Adhesions After Myomectomy
An observational study of Myoma;Uterus, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myoma;Uterus
- What is being tested?
- Diagnostic hysteroscopy
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jan 2020to 29 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Diagnosis of one or more uterine myomas
- Desire to preserve fertility/uterus
- Myomectomy (by laparotomy or laparoscopy)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myoma;Uterus
- Being tested
- Diagnostic hysteroscopy
- Keywords
- Diagnostic hysteroscopy, Fertility, Intrauterine adhesions, Myomectomy, Uterine fibroids
- Medical subject headings
- Myofibroma, Gynatresia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic hysteroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Laparotomic myomectomy | Women undergoing uterine myomectomy by open surgery (laparotomy). Receives: Diagnostic Test: Diagnostic hysteroscopy | |
| Laparoscopic myomectomy | Women undergoing uterine myomectomy by laparoscopy. Receives: Diagnostic Test: Diagnostic hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after myomectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start21 Jan 2020
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Jose Carugno, Study director, University of MiamiAndrea Tinelli, Study chair, Vito Fazzi HospitalAntonio Simone Laganà, Study chair, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030273
- Sponsor's protocol ID
- ADAM-1
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2019
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon reasonable request
Publications
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.
PubMed 35168241
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Intrauterine Adhesions After Myomectomy: A Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT04030273
- Acronym / sponsor ID
- ADAM-1
- Conditions
- Myoma;Uterus
- Keywords
- Diagnostic hysteroscopy, Fertility, Intrauterine adhesions, Myomectomy, Uterine fibroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparotomic myomectomy | – | Diagnostic Test: Diagnostic hysteroscopyWomen undergoing uterine myomectomy by open surgery (laparotomy). |
| Laparoscopic myomectomy | – | Diagnostic Test: Diagnostic hysteroscopyWomen undergoing uterine myomectomy by laparoscopy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of one or more uterine myomas
- Desire to preserve fertility/uterus
- Myomectomy (by laparotomy or laparoscopy)
Key exclusion criteria (8 listed)
- Adults unable to consent
- Pregnant women
- Prisoners
- History of previous intrauterine procedures such as dilation and curettage
- History of known intrauterine adhesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic hysteroscopyDiagnostic 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. | Diagnostic test | Laparoscopic myomectomy, Laparotomic myomectomy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 35168241Lagana 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.
- Individual participant dataSharing planned: Yes. Available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Carugno study director
University of Miami
Andrea Tinelli study chair
Vito Fazzi Hospital
Antonio Simone Laganà study chair
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myoma;Uterus, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intrauterine adhesions (time frame: 3 months after myomectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04030273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.