Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection

Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483348
• Other study ID #: 4276
• Status: Completed
• Start date: February 17, 2022
• Est. completion date: April 28, 2022

Study information

• Verified date: August 2022
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Prognostic Factors
• Uterine Bleeding
• Uterine Hemorrhage

Intervention

Procedure:
• Endometrial Ablation
Thermal endometrial ablation
• Repeated gynecological procedure
subsequent gynecological procedures such as hysterectomy for any benign indication, D&C or repeat ablation.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman	Al Jubaiha

Sponsors (1)

Lead Sponsor	Collaborator
Naser Al-Husban

Country where clinical trial is conducted

Jordan, 

References & Publications (6)

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: Obs — View Citation

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. Epub 2006 Dec 7. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Subsequent gynecological procedures after failed ablation	To find the subsequent gynecological procedures that patients with unsuccessful ablation had	from September 2016 through February 2022