Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection

Completed

• Conditions: Treatment Failures; Uterine Bleeding; Prognostic Factors
• Interventions: Procedure: Endometrial Ablation; Procedure: Repeated gynecological procedure

• Registration Number: NCT05483348
• Lead Sponsor: Naser Al-Husban

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.

Study Timeline

• Study Start: 2022-02-17
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Study First Submitted: 2022-07-16
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who had successful endometrial ablation	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.
Patients who had unsuccessful endometrial ablation	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.
Patients who had unsuccessful endometrial ablation	Repeated gynecological procedure	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.

Primary Outcome Measures

Name	Time	Method
Clinical Predictive factors of successful endometrial ablation	from September 2016 through February 2022	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Al Jubaiha, Jordan