Clinical trial NCT05483348: Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection
Official title: Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection; Retrospective Study at a Tertiary University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Bleeding
Treatment Failures
Prognostic Factors
Keywords: Endometrial Ablation Technique
Uterine Bleeding
Treatment Failures
Prognostic Factors
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 95
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had attended the gynecology department at Jordan University Hospital.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Predictive factors of successful endometrial ablation
timeFrame: from September 2016 through February 2022
Secondary outcomes:
measure: The failure rate of endometrial ablation for uterine bleeding
timeFrame: from September 2016 through February 2022
measure: Subsequent gynecological procedures after failed ablation
timeFrame: from September 2016 through February 2022
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
state: Al Jubaiha
Study officials:
affiliation: Assistant professor of obstetrics and gynecology, the university of jordan
name: Naser AL- Husban, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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. doi: 10.1159/000097847. Epub 2006 Dec 7.
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.2016.02.002. Epub 2016 Feb 9.