92
Participants
Start Date
August 23, 2021
Primary Completion Date
January 1, 2023
Study Completion Date
April 1, 2023
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.
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."
University of Health Sciences Umraniye Education and Research Hospital, Istanbul
Pendik Medipol University Hospital, Istanbul
Collaborators (1)
Istanbul Medipol University Hospital
OTHER
Gama Medical Ltd.
UNKNOWN
Umraniye Education and Research Hospital
OTHER_GOV