Hemorrhoid Radiofrequency

Recruiting

• Conditions: Hemorrhoid Prolapse

• Registration Number: NCT06079892
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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").

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-10-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Measurement of patient satisfaction after surgery	3 months post procedure	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.
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)
description of procedure complication	3 months post procedure

Trial Locations

Locations (1)

Fondation Hôpital Saint Joseph; 🇫🇷 Paris, France