LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty for Hemorrhoidal Disease

Not Applicable

Completed

• Conditions: Hemorrhoids

• Registration Number: NCT04981600
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. he aim of this study is to compare the two contemporary minimally invasive methods.

Detailed Description

Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. The indication of treatment depends primarily on the individual burden of the disease rather than its stage. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. Although conventional resection based techniques have less recurrence rates, they tend to have a greater chance of leading to various postoperative complications such as significant postoperative pain, urinary retention, bleeding, abscess formation, anal stenosis, anal fissure and fecal incontinence, deeming non-resection based less invasive techniques more favorable in terms of postoperative morbidity. The main mechanism of non-resection based techniques is creating an inflammatory stimulus inside the prolapsed hemorrhoidal tissue which ultimately causes fibrosis and relocation of the tissue above the dentate line. There are several randomized controlled trials which compared the laser procedure especially with resection based methods in this regard. However, to our knowledge, which is based on a thorough search in the Pubmed and Google Scholar, no randomized clinical trial has been made comparing the radiofrequency ablation method with the laser ablation technique .

The aim of this study is to compare the two contemporary minimally invasive methods in terms of postoperative complications, recovery process and postoperative pain.

Study Timeline

• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-07-29
• Study Start: 2021-08-23
• Primary Completion: 2023-01-01
• Study Completion: 2023-04-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Symptomatic patients who applied to the general surgery outpatient clinic due to stage 2 or 3 hemorrhoidal disease, unresponsive to medical treatment
• Patients who have not undergone any previous surgery due to hemorrhoidal disease
• Patients with written informed voluntary consent forms

Exclusion Criteria

• Concomitant anorectal disease
• History of anticoagulant use
• Fecal incontinence complaint
• History of active steroid/immunosuppressive use for any reason
• Pregnancy
• Inflammatory Bowel Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Healing	4 month	Hemorrhoid downgrading of at least 1 grade
Change in Visual analog score (VAS) at 4 weeks	1st week and 4th week	Patients are simply asked to score their pain from 1 to 10, which is typically called visual analog scale in the literature, with higher scores representing more severe pain.

Secondary Outcome Measures

Name	Time	Method
Operation Time	Operation 1 Day	Specified in hours
Number of admissions	4 months after the procedure	Outpatient follow up per routine or due to several complications such as pain, mucosal discharge, itching etc.
Rate of complications	1st week, 4th week and 4th month	Such as bleeding, infection and hematoma
Quality of Life for HSS (Hemorrhoid Severity Score)	1st week and 4th week	Hemorrhoid Severity Score (HSS) is the total score obtained by the sum of the numerical grades of pruritis, pain, prolapse, bleeding and soiling. All the five components in this classification system are graded into four grades ranging from 0 to 3.
Hospitalization Time	Discharge day after the surgery up to 3 days	Specified in days

Trial Locations

Locations (2)

Pendik Medipol University Hospital; 🇹🇷 Istanbul, Pendik, Turkey

University of Health Sciences Umraniye Education and Research Hospital; 🇹🇷 İstanbul, Turkey