Prevalence of Intrauterine Adhesions After Abdominal Myomectomy

September 28, 2021 updated by: Antonio Simone Laganà, Università degli Studi dell'Insubria

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

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

Genders Eligible for Study

Female

Sampling Method

Non-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 are scheduled to undergo laparoscopic, robotic assisted or open myomectomy.

Description

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

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
Open (laparotomic) myomectomy
Women undergoing uterine myomectomy by open surgery (laparotomy).
Diagnostic test: 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.
Laparoscopic myomectomy
Women undergoing uterine myomectomy by laparoscopy.
Diagnostic test: 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.
Robotic myomectomy
Women undergoing uterine myomectomy by robotic surgery.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrauterine adhesions
Time Frame: 3 months after myomectomy
Presence of intrauterine adhesion, following the American Fertility Society classification (Fertil Steril. 1988;49:944-955.) in mild, moderate, or severe.
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 (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2024

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)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

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)?

UNDECIDED

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.

Clinical Trials on Myoma;Uterus

Clinical Trials on Diagnostic hysteroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe