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

NCT04981600 | Completed

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01/183
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhoids

Keywords

Radiofrequency ablation; Laser hemorrhoidoplasty; Pain; Recurrence

Outcome Measures

Primary Outcomes (2)

• Rate of Healing

  Hemorrhoid downgrading of at least 1 grade

  4 month

• Change in Visual analog score (VAS) at 4 weeks

  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.

  1st week and 4th week

Secondary Outcomes (5)

• Quality of Life for HSS (Hemorrhoid Severity Score)

  1st week and 4th week

• Operation Time

  Operation 1 Day

• Hospitalization Time

  Discharge day after the surgery up to 3 days

• Number of admissions

  4 months after the procedure

• Rate of complications

  1st week, 4th week and 4th month

Study Arms (2)

Laser Group

ACTIVE COMPARATOR

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.

Device: Laser

RF (Radiofrequency) Group

ACTIVE COMPARATOR

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.

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation 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.

RF (Radiofrequency) Group

Laser 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.

Laser Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead
• Istanbul Medipol University Hospital: collaborator
• Gama Medical Ltd.: collaborator

Study Sites (2)

Pendik Medipol University Hospital

Istanbul, Pendik, 34893, Turkey (Türkiye)

Location

University of Health Sciences Umraniye Education and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

Location

Related Publications (5)

• Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.

  PMID: 21932016 BACKGROUND

• Maloku H, Gashi Z, Lazovic R, Islami H, Juniku-Shkololli A. Laser Hemorrhoidoplasty Procedure vs Open Surgical Hemorrhoidectomy: a Trial Comparing 2 Treatments for Hemorrhoids of Third and Fourth Degree. Acta Inform Med. 2014 Dec;22(6):365-7. doi: 10.5455/aim.2014.22.365-367. Epub 2014 Dec 19.

  PMID: 25684841 BACKGROUND

• Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.

  PMID: 25603811 BACKGROUND

• Eddama MMR, Everson M, Renshaw S, Taj T, Boulton R, Crosbie J, Cohen CR. Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality. Tech Coloproctol. 2019 Aug;23(8):769-774. doi: 10.1007/s10151-019-02054-2. Epub 2019 Aug 9.

  PMID: 31399891 BACKGROUND

• Giamundo P, Salfi R, Geraci M, Tibaldi L, Murru L, Valente M. The hemorrhoid laser procedure technique vs rubber band ligation: a randomized trial comparing 2 mini-invasive treatments for second- and third-degree hemorrhoids. Dis Colon Rectum. 2011 Jun;54(6):693-8. doi: 10.1007/DCR.0b013e3182112d58.

  PMID: 21552053 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids; Pain; Recurrence

Interventions

Radiofrequency Ablation; Lasers

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Hanife Ş Ülgür, MD

  University of Health Sciences, Umraniye Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 29, 2021
• Study Start: August 23, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)