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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2023-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laser Group

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.

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type DEVICE

The same preoperative preparations will be done for the laser group as well. The NeoV 1470 (neoLaser, Israel) device will be used in this group. Following routine placement of the patient in lithotomy position and determining the cushion to be treated, a 12 W laser beam with a wavelength of 1470nm will be inserted into the cushion above the dentate line and advanced to the apex and approximately 3 laser shots are delivered throughout the course caudally, the number of which can be altered according to the size targeted cushion. Finally the procedure will be completed after gentle cold application.

An enema will be given to the patients in both study groups in the morning of the operation and patients will be discharged with analgesics on the same day.

RF (Radiofrequency) Group

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.

Group Type ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type DEVICE

Patients in the RF group will be first examined under anesthesia at the beginning of the procedure in lithotomy position. Approximately 3-6 ml of 20 mg/ml Lidocaine (Jetokaine, Adeka İlaç Sanayi, Samsun) solution will be injected between the cushion and the internal anal sphincter to minimize heat conduction to the surrounding tissues during the procedure. The HPR45i probe (F Care Systems, Antwerpen, Belgium) connected to the Rafaelo ® EVRF machine (F Care Systems, Antwerpen, Belgium) will be placed inside the cushion and 25 watts of RF energy will be transmitted. Care will be taken by not exceeding the dentate line caudally. The recommended Joule value for each operation is 1200-3000 J. Then cold is applied on the cushion, reducing the temperature of the tissue and preventing damage to the surrounding tissues. The same procedure will be performed for other pathologic cushions as well.

Interventions

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Radiofrequency ablation

Patients in the RF group will be first examined under anesthesia at the beginning of the procedure in lithotomy position. Approximately 3-6 ml of 20 mg/ml Lidocaine (Jetokaine, Adeka İlaç Sanayi, Samsun) solution will be injected between the cushion and the internal anal sphincter to minimize heat conduction to the surrounding tissues during the procedure. The HPR45i probe (F Care Systems, Antwerpen, Belgium) connected to the Rafaelo ® EVRF machine (F Care Systems, Antwerpen, Belgium) will be placed inside the cushion and 25 watts of RF energy will be transmitted. Care will be taken by not exceeding the dentate line caudally. The recommended Joule value for each operation is 1200-3000 J. Then cold is applied on the cushion, reducing the temperature of the tissue and preventing damage to the surrounding tissues. The same procedure will be performed for other pathologic cushions as well.

Intervention Type DEVICE

Laser

The same preoperative preparations will be done for the laser group as well. The NeoV 1470 (neoLaser, Israel) device will be used in this group. Following routine placement of the patient in lithotomy position and determining the cushion to be treated, a 12 W laser beam with a wavelength of 1470nm will be inserted into the cushion above the dentate line and advanced to the apex and approximately 3 laser shots are delivered throughout the course caudally, the number of which can be altered according to the size targeted cushion. Finally the procedure will be completed after gentle cold application.

An enema will be given to the patients in both study groups in the morning of the operation and patients will be discharged with analgesics on the same day.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No