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

NACompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

August 23, 2021

Primary Completion Date

January 1, 2023

Study Completion Date

April 1, 2023

Conditions
Hemorrhoids
Interventions
DEVICE

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.

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."

Trial Locations (2)

34764

University of Health Sciences Umraniye Education and Research Hospital, Istanbul

34893

Pendik Medipol University Hospital, Istanbul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Istanbul Medipol University Hospital

OTHER

collaborator

Gama Medical Ltd.

UNKNOWN

lead

Umraniye Education and Research Hospital

OTHER_GOV

NCT04981600 - LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty for Hemorrhoidal Disease | Biotech Hunter | Biotech Hunter