Hemorrhoid Radiofrequency (RFH)

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").

Study Overview

• Status: Recruiting
• Conditions: Hemorrhoid Prolapse
• Intervention / Treatment: Procedure: radiofrequency

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Hélène Beaussier, pharmaD, phD; Phone Number: +33144127038; Email: crc@ghpsj.fr
• Study Contact Backup: Name: Amine Antonin Alam, MD; Phone Number: +331441286 94; Email: aalam@ghpsj.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Fondation Hôpital Saint Joseph
    • Contact: Juliette COURTIADE MAHLER, phD; Phone Number: +33144127963; Email: jcourtiade@ghpsj.fr
    • Contact: Amim Antonin Alam, MD; Phone Number: +33144128694; Email: aalam@ghpsj.fr
    • Principal Investigator: Amim Antonin Alam, MD
    • Sub-Investigator: Vincent de Parades, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	3 months post procedure
description of procedure complication		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	3 months post procedure

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: radiofrequency
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Prolapse; Hemorrhoids
• Other Study ID Numbers: 647-AAM-RFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No