Hemorrhoid ProlapseRFHNCT06079892
Hemorrhoid Radiofrequency
An observational study of Hemorrhoid Prolapse, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoid Prolapse
- What is being tested?
- radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 1 Jan 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient suffering for Haemorroidal pathology and requiring a removal procedure to whom a Radiofrequency procedure was performed
Who may be able to join
- Age ≥ 18 years
- Presence of haemorrhoidal pathology
- Patient operated on between March 2017 and March 2023, using the radiofrequency technique
- French-speaking patient
Who cannot join
- ano-perineal involvement in Crohn's disease
- perianal fistula
- non-quiescent IBD
- radiation-induced rectitis
- psychiatric pathology.
- under guardianship or curatorship
Show all 9Show fewer
- deprived of liberty
- under court protection
- Patient objecting to the use of his/her data for this research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Fondation Hôpital Saint Joseph
Paris, 75014
Amim Antonin Alam, MD, +33144128694, aalam@ghpsj.fr
Juliette COURTIADE MAHLER, phD, +33144127963, jcourtiade@ghpsj.fr
About this study
Official title: Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology
Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution.
The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively.
The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").
- Conditions
- Hemorrhoid Prolapse
- Being tested
- radiofrequency
- Keywords
- radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequencyProcedure or surgery
haemorrhoidal removal using radiofrequency
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of radiofrequency treatment efficiency
Assessement of the procedure efficiency on prolapsus (using Goligher Score) and bleeding (using Haemorrhoidal bleeding score).
Procedure is considered efficient when Goligher Score =1 AND HBS = 0
Measured: 3 months post procedure
Secondary outcomes (4)
Measurement of patient satisfaction after surgery
Patient will be asked :
- would you recommand this procedure to a friend ? (yes or no)
- Knowing your personnal outcome would you undergo the same procedure again ? (yes or no)
Patients are considered satisfied by the procedure when they answered yes to at least one of the questions.
Measured: 3 months post procedure
Incidence rate of procedure complication
incidence rate of haemorrhagic complication or acute urinary retention or other complication (such as post surgery abcess, localized infection, haematoma)
Measured: 3 months post procedure
description of procedure complication
Measured: 3 months post procedure
Identification of predictive factor for success
pre-procedure parameters will be correlated with procedure success (Goligher Score =1 AND HBS = 0 after procedure) in order to identify which factors give a higher chance of success
Measured: 3 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Mar 2017
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoid ProlapseStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079892
- Sponsor's protocol ID
- 647-AAM-RFH
- Acronym
- RFH
- Status last verified
- Mar 2024
- First submitted
- 3 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology
- ClinicalTrials.gov ID
- NCT06079892
- Acronym / sponsor ID
- RFH / 647-AAM-RFH
- Conditions
- Hemorrhoid Prolapse
- Keywords
- radiofrequency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Oct 2023 (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.
Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution.
The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively.
The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient suffering for Haemorroidal pathology and requiring a removal procedure to whom a Radiofrequency procedure was performed
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Presence of haemorrhoidal pathology
- Patient operated on between March 2017 and March 2023, using the radiofrequency technique
- French-speaking patient
Key exclusion criteria (9 listed)
- ano-perineal involvement in Crohn's disease
- perianal fistula
- non-quiescent IBD
- radiation-induced rectitis
- psychiatric pathology.
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 |
|---|---|---|
| radiofrequencyhaemorrhoidal removal using radiofrequency | Procedure or surgery | – |
Primary outcome
Evaluation of radiofrequency treatment efficiency
Time frame: 3 months post procedure
Assessement of the procedure efficiency on prolapsus (using Goligher Score) and bleeding (using Haemorrhoidal bleeding score). Procedure is considered efficient when Goligher Score =1 AND HBS = 0
4 secondary outcomes
Measurement of patient satisfaction after surgery
Time frame: 3 months post procedure
Incidence rate of procedure complication
Time frame: 3 months post procedure
description of procedure complication
Time frame: 3 months post procedure
Identification of predictive factor for success
Time frame: 3 months post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 Hemorrhoid Prolapse, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amine Antonin Alam, MD (+331441286 94, aalam@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of radiofrequency treatment efficiency (time frame: 3 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.