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

Umraniye Education and Research Hospital

Status: Completed

Conditions: Hemorrhoids

Treatments: Device: Radiofrequency ablation; Device: Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04981600

B.10.1.TKH.4.34.H.GP.0.01/183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Laser Group

Active Comparator group

Description:

Grade II-III hemorrhoids present a special challenge to surgeons since aggressive surgery exposes the patient to several per- and postoperative complications. Therefore new techniques have been developed and one of the most popular contemporary technique is laser hemorrhoidectomy. By this technique a laser probe is inserted above the dentate line and advanced to the apex of the cushion and several shots are delivered while pulling out the probe gradually. The idea is to compromise the vascular flow of corpus cavernosum recti, hence shrinking the hemorrhoidal cushion.

Treatment:

Device: Laser

RF (Radiofrequency) Group

Active Comparator group

Description:

Another recent and similar method is radiofrequency coagulation which depends on transmitting radiofrequency waves to tissue. This transmission results in conversion of radiofrequency waves into heat and causes coagulation necrosis in corpus cavernosum recti. The necrosis leads to fibrosis of the surrounding vessels and consequently cushion shrinkage is achieved.

Treatment:

Device: Radiofrequency ablation