Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection

Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection; Retrospective Study at a Tertiary University Hospital

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

Study Overview

• Status: Completed
• Conditions: Prognostic Factors; Uterine Bleeding; Treatment Failures
• Intervention / Treatment: Procedure: Endometrial Ablation; Procedure: Repeated gynecological procedure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Jordan
  • Al Jubaiha
    • Amman, Al Jubaiha, Jordan, 11942
      • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients who had attended the gynecology department at Jordan University Hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Endometrial Ablation; 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.	Procedure: Endometrial Ablation; Thermal endometrial ablation; Procedure: Repeated gynecological procedure; subsequent gynecological procedures such as hysterectomy for any benign indication, D&C or repeat ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Predictive factors of successful endometrial ablation	the outcome of hysteroscopic endometrial ablation whether it was a failure or a success; failure was defined as persistent of heavy bleeding after the ablation.	from September 2016 through February 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The failure rate of endometrial ablation for uterine bleeding	To find the failure rate of endometrial ablation that is done for uterine bleeding	from September 2016 through February 2022
Subsequent gynecological procedures after failed ablation	To find the subsequent gynecological procedures that patients with unsuccessful ablation had	from September 2016 through February 2022

Collaborators and Investigators

• Sponsor: Naser Al-Husban
• Investigators: Principal Investigator: Naser AL- Husban, MD, Assistant professor of obstetrics and gynecology, the university of jordan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Obstet Gynecol. 2010 Mar;115(3):663.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: July 16, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Prognostic Factors; Uterine Bleeding; Endometrial Ablation Technique; Treatment Failures
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: 4276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No