Hemorrhoid Radiofrequency
RFH
Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology
1 other identifier
observational
80
1 country
1
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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMarch 12, 2024
March 1, 2024
7.6 years
October 3, 2023
March 11, 2024
Conditions
Keywords
Outcome Measures
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
3 months post procedure
Secondary Outcomes (4)
Measurement of patient satisfaction after surgery
3 months post procedure
Incidence rate of procedure complication
3 months post procedure
description of procedure complication
3 months post procedure
Identification of predictive factor for success
3 months post procedure
Interventions
haemorrhoidal removal using radiofrequency
Eligibility Criteria
Patient suffering for Haemorroidal pathology and requiring a removal procedure to whom a Radiofrequency procedure was performed
You may qualify if:
- Age ≥ 18 years
- Presence of haemorrhoidal pathology
- Patient operated on between March 2017 and March 2023, using the radiofrequency technique
- French-speaking patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation Hôpital Saint Joseph
Paris, 75014, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 12, 2023
Study Start
March 1, 2017
Primary Completion
October 1, 2024
Study Completion
January 1, 2025
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share