Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection

NCT ID: NCT05483348

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-17

Study Completion Date

2022-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine the predictive factors of endometrial ablation failure in the management of uterine bleeding.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a retrospective cohort study for women who have been treated with Thermal endometrial ablation due to uterine bleeding. The main purpose of this study is to demonstrate the possible risk factors associated with endometrial ablation failure causing patients to need subsequent gynecological procedures or undergoing hysterectomy for definitive treatment. Such efforts are made in order to anticipate the morbidity and mortality associated with patients in such conditions and to effectively stratify those patients to appropriate treatment techniques.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Bleeding Treatment Failures Prognostic Factors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients who had successful endometrial ablation

Patients included in this group experienced abnormal uterine bleeding and underwent endometrial ablation. Successful ablation was defined as not undergoing subsequent gynecological procedures such as hysterectomy for any benign indication, D\&C or repeat ablation within 36 months after the endometrial ablation.

Endometrial Ablation

Intervention Type PROCEDURE

Thermal endometrial ablation

Patients who had unsuccessful endometrial ablation

Patients included in this group experienced abnormal uterine bleeding and underwent endometrial ablation. Unsuccessful ablation was defined as undergoing subsequent gynecological procedures such as hysterectomy for any benign indication, D\&C or repeat ablation within 36 months after the endometrial ablation.

Endometrial Ablation

Intervention Type PROCEDURE

Thermal endometrial ablation

Repeated gynecological procedure

Intervention Type PROCEDURE

subsequent gynecological procedures such as hysterectomy for any benign indication, D\&C or repeat ablation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endometrial Ablation

Thermal endometrial ablation

Intervention Type PROCEDURE

Repeated gynecological procedure

subsequent gynecological procedures such as hysterectomy for any benign indication, D\&C or repeat ablation.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients who had their endometrial ablation at Jordan University Hospital.

Exclusion Criteria

* Patients whose index ablation or subsequent re-intervention could not be confirmed in detailed operative reports were excluded
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Naser Al-Husban

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Naser Al-Husban

Assistant professor of obstetrics and gynecology, the university of jordan

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naser AL- Husban, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of obstetrics and gynecology, the university of jordan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jordan University Hospital

Amman, Al Jubaiha, Jordan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Jordan

References

Explore related publications, articles, or registry entries linked to this study.

Wortman M. Late-onset endometrial ablation failure. Case Rep Womens Health. 2017 Jul 12;15:11-28. doi: 10.1016/j.crwh.2017.07.001. eCollection 2017 Jul.

Reference Type RESULT
PMID: 29593995 (View on PubMed)

Riley KA, Davies MF, Harkins GJ. Characteristics of patients undergoing hysterectomy for failed endometrial ablation. JSLS. 2013 Oct-Dec;17(4):503-7. doi: 10.4293/108680813X13693422520602.

Reference Type RESULT
PMID: 24398189 (View on PubMed)

Smithling KR, Savella G, Raker CA, Matteson KA. Preoperative uterine bleeding pattern and risk of endometrial ablation failure. Am J Obstet Gynecol. 2014 Nov;211(5):556.e1-6. doi: 10.1016/j.ajog.2014.07.005. Epub 2014 Jul 11.

Reference Type RESULT
PMID: 25019488 (View on PubMed)

El-Nashar SA, Hopkins MR, Creedon DJ, St Sauver JL, Weaver AL, McGree ME, Cliby WA, Famuyide AO. Prediction of treatment outcomes after global endometrial ablation. Obstet Gynecol. 2009 Jan;113(1):97-106. doi: 10.1097/AOG.0b013e31818f5a8d.

Reference Type RESULT
PMID: 19104365 (View on PubMed)

Gemer O, Kruchkovich J, Huerta M, Kapustian V, Kroll D, Anteby E. Perioperative predictors of successful hysteroscopic endometrial ablation. Gynecol Obstet Invest. 2007;63(4):205-8. doi: 10.1159/000097847. Epub 2006 Dec 7.

Reference Type RESULT
PMID: 17159353 (View on PubMed)

Shazly SA, Famuyide AO, El-Nashar SA, Breitkopf DM, Hopkins MR, Laughlin-Tommaso SK. Intraoperative Predictors of Long-term Outcomes After Radiofrequency Endometrial Ablation. J Minim Invasive Gynecol. 2016 May-Jun;23(4):582-9. doi: 10.1016/j.jmig.2016.02.002. Epub 2016 Feb 9.

Reference Type RESULT
PMID: 26867699 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4276

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Conservative Management for PAS Pilot
NCT05139498 RECRUITING NA