Uterine BleedingNCT05483348
Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection
An observational study of Uterine Bleeding and Treatment Failures, run by Naser Al-Husban at 1 site in Jordan.
Trial summary
To determine the predictive factors of endometrial ablation failure in the management of uterine bleeding. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Bleeding, Treatment Failures, Prognostic Factors
- What is being tested?
- Endometrial Ablation and Repeated gynecological procedure
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteJordan
- Study dates
- 17 Feb 2022to 28 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who had attended the gynecology department at Jordan University Hospital.
Who may be able to join
- All patients who had their endometrial ablation at Jordan University Hospital.
Who cannot join
- Patients whose index ablation or subsequent re-intervention could not be confirmed in detailed operative reports were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Bleeding, Treatment Failures, Prognostic Factors
- Being tested
- Endometrial Ablation, Repeated gynecological procedure
- Keywords
- Endometrial Ablation Technique, Uterine Bleeding, Treatment Failures, Prognostic Factors
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial AblationProcedure or surgery
Thermal endometrial ablation
Repeated gynecological procedureProcedure or surgery
subsequent gynecological procedures such as hysterectomy for any benign indication, D\&C or repeat ablation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endometrial Ablation; Procedure: Repeated gynecological procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from September 2016 through February 2022
Secondary outcomes (2)
The failure rate of endometrial ablation for uterine bleeding
To find the failure rate of endometrial ablation that is done for uterine bleeding
Measured: from September 2016 through February 2022
Subsequent gynecological procedures after failed ablation
To find the subsequent gynecological procedures that patients with unsuccessful ablation had
Measured: from September 2016 through February 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start17 Feb 2022
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naser Al-Husban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naser Al-Husban, University of Jordan
- Investigators
- Naser AL- Husban, MD, Principal investigator, Assistant professor of obstetrics and gynecology, the university of jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483348
- Sponsor's protocol ID
- 4276
- Status last verified
- Aug 2022
- First submitted
- 16 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
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.
PubMed 29593995Riley 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.
PubMed 24398189Smithling 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.
PubMed 25019488El-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.
PubMed 19104365Gemer 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.
PubMed 17159353Shazly 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.
PubMed 26867699
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Predictive Factors of Success of Hysteroscopic Endometrial Ablation/Resection; Retrospective Study at a Tertiary University Hospital
- ClinicalTrials.gov ID
- NCT05483348
- Acronym / sponsor ID
- 4276
- Conditions
- Uterine Bleeding, Treatment Failures, Prognostic Factors
- Keywords
- Endometrial Ablation Technique, Uterine Bleeding, Treatment Failures, Prognostic Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Naser Al-HusbanUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who had successful endometrial ablation | – | Procedure: Endometrial AblationPatients 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 | – | Procedure: Endometrial Ablation, Procedure: Repeated gynecological procedurePatients 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who had attended the gynecology department at Jordan University Hospital.
Key inclusion criteria (1 listed)
- All patients who had their endometrial ablation at Jordan University Hospital.
Key exclusion criteria (1 listed)
- Patients whose index ablation or subsequent re-intervention could not be confirmed in detailed operative reports were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial AblationThermal endometrial ablation | Procedure or surgery | Patients who had successful endometrial ablation, Patients who had unsuccessful endometrial ablation |
| Repeated gynecological proceduresubsequent gynecological procedures such as hysterectomy for any benign indication, D\&C or repeat ablation. | Procedure or surgery | Patients who had unsuccessful endometrial ablation |
Primary outcome
Clinical Predictive factors of successful endometrial ablation
Time frame: 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.
2 secondary outcomes
The failure rate of endometrial ablation for uterine bleeding
Time frame: from September 2016 through February 2022
Subsequent gynecological procedures after failed ablation
Time frame: from September 2016 through February 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Results publication: PubMed 29593995Wortman 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.
- Results publication: PubMed 24398189Riley 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.
- Results publication: PubMed 25019488Smithling 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.
- Results publication: PubMed 19104365El-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.
- Results publication: PubMed 17159353Gemer 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.
- Results publication: PubMed 26867699Shazly 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.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naser AL- Husban, MD principal investigator
Assistant professor of obstetrics and gynecology, the university of jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Bleeding and Treatment Failures, run by Naser Al-Husban at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Predictive factors of successful endometrial ablation (time frame: from September 2016 through February 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05483348, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.