RFH: Hemorrhoid Radiofrequency

Sponsor
Fondation Hôpital Saint-Joseph (Other)
Overall Status
Recruiting
CT.gov ID
NCT06079892
Collaborator
(none)
80
1
82
1

Study Details

Study Description

Brief 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").

Condition or Disease Intervention/Treatment Phase
  • Procedure: radiofrequency

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Evaluation of radiofrequency treatment efficiency [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

Secondary Outcome Measures

  1. Measurement of patient satisfaction after surgery [3 months post procedure]

    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.

  2. Incidence rate of procedure complication [3 months post procedure]

    incidence rate of haemorrhagic complication or acute urinary retention or other complication (such as post surgery abcess, localized infection, haematoma)

  3. description of procedure complication [3 months post procedure]

  4. Identification of predictive factor for success [3 months post procedure]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation Hôpital Saint Joseph Paris France 75014

Sponsors and Collaborators

  • Fondation Hôpital Saint-Joseph

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Hôpital Saint-Joseph
ClinicalTrials.gov Identifier:
NCT06079892
Other Study ID Numbers:
  • 647-AAM-RFH
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Hôpital Saint-Joseph
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2023