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RecruitingNCT06079892RFHUpdated Mar 12, 2024

Hemorrhoid Radiofrequency

An observational study in Hemorrhoid Prolapse, sponsored by Fondation Hôpital Saint-Joseph. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2017; still recruiting 9 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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. 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").

02

Conditions studied

  • Hemorrhoid Prolapse

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Keywords

  • radiofrequency
03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 80 is below the median of 151 across 49 observational studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patient suffering for Haemorroidal pathology and requiring a removal procedure to whom a Radiofrequency procedure was performed

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Presence of haemorrhoidal pathology
  • Patient operated on between March 2017 and March 2023, using the radiofrequency technique
  • French-speaking patient

Exclusion criteria

Exclusion Criteria:

  • ano-perineal involvement in Crohn's disease
  • perianal fistula
  • non-quiescent IBD
  • radiation-induced rectitis
  • psychiatric pathology.
  • under guardianship or curatorship
  • deprived of liberty
  • under court protection
  • Patient objecting to the use of his/her data for this research
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • Procedureradiofrequency

    haemorrhoidal removal using radiofrequency

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months post procedure

Secondary outcomes

  1. Measurement of patient satisfaction after surgery

    Patient will be asked : 1. would you recommand this procedure to a friend ? (yes or no) 2. 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.

    Time frame: 3 months post procedure

  2. 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)

    Time frame: 3 months post procedure

  3. description of procedure complication

    Time frame: 3 months post procedure

  4. 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

    Time frame: 3 months post procedure

07

Study locations

1 of 1 sites recruiting
  • Fondation Hôpital Saint Joseph
    Paris, 75014, France
    Recruiting
    • Amim Antonin Alam, MD · Contactaalam@ghpsj.fr · +33144128694
    • Juliette COURTIADE MAHLER, phD · Contactjcourtiade@ghpsj.fr · +33144127963
    • Amim Antonin Alam, MD · Principal investigator
    • Vincent de Parades, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06079892
Responsible party
Sponsor
First posted
Oct 12, 2023
Start date
Mar 1, 2017
Primary completion
Oct 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Mar 12, 2024

Study contacts

Amine Antonin Alam, MD
Contact
aalam@ghpsj.fr
+331441286 94
Hélène BEAUSSIER, PharmaD, PhD
Contact
crc@ghpsj.fr
+33144127038

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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