Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection

NCT05483348 | Completed

• 1 other identifier: 4276
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Bleeding; Treatment Failures; Prognostic Factors

Keywords

Endometrial Ablation Technique; Uterine Bleeding; Treatment Failures; Prognostic Factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The failure rate of endometrial ablation for uterine bleeding

  from September 2016 through February 2022

• Subsequent gynecological procedures after failed ablation

  from September 2016 through February 2022

Study Arms (2)

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

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; Procedure: Repeated gynecological procedure

Interventions

Endometrial Ablation PROCEDURE

Thermal endometrial ablation

Patients who had successful endometrial ablation; Patients who had unsuccessful endometrial ablation

Repeated gynecological procedure PROCEDURE

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

Patients who had unsuccessful endometrial ablation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Naser Al-Husban: lead

Study Sites (1)

Jordan University Hospital

Amman, Al Jubaiha, 11942, Jordan

Location

Related Publications (6)

• 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.

  PMID: 29593995 RESULT

• 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.

  PMID: 24398189 RESULT

• 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.

  PMID: 25019488 RESULT

• 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.

  PMID: 19104365 RESULT

• 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.

  PMID: 17159353 RESULT

• 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.

  PMID: 26867699 RESULT

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

Endometrial Ablation Techniques

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Naser AL- Husban, MD

  Assistant professor of obstetrics and gynecology, the university of jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of obstetrics and gynecology, the university of jordan

Study Record Dates

• First Submitted: July 16, 2022
• First Posted: August 2, 2022
• Study Start: February 17, 2022
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-08

Locations

JO (1)