Radiofrequency-induced thermotherapy (RFITT) allows one to have a locally concentrated impact of thermal energy on pathological tissue. With this purpose RFITT was used in the therapy of advanced haemorrhoids from 2007 to 2010 at Atlas Hospital in a prospective study that was approved by the ethical committee in June 2007. After successful patient recruitment the Celon method was used from September 2007 onwards [6
We used the CelonLab PRECISION as an energy source that allows adjustable output as well as audio-feedback control of the radiofrequency energy on the haemorrhoids. As the RFITT generator shuts down automatically if the targeted impedance has been reached, under/overtreatment can be avoided. We chose to use the RFITT applicator (Celon Pro-BREATH), which is a bipolar electrode with a diameter of 1.1 mm and an application length of 10 mm. Radiofrequency current flows just between the two parts of the bipolar electrode, forming a clearly defined coagulation area. The thermal effect in the tissue has a therapeutic impact on the endothelial lining of the vascular wall, leading to a well-controlled obliteration.
As the Celon system enables impedance feedback, electric current stops passing the tissue automatically upon termination of the coagulation. The RFITT can be applied safely thanks to an acoustic signal indicating the optimum coagulation stage. In the case of RFITT application for the treatment of haemorrhoids, high frequency electric current flows through haemorrhoidal tissue, which is in contact with the bipolar electrode, and heats it up to 80°C. This leads to contraction of the vascular wall of the haemorrhoid, interruption of blood flow through the haemorrhoidal plexus, and retraction back into the anus.
Patients with haemorrhoidal disease in stages III (manually reducible prolapse) and IV (permanent prolapse) were included in the study. All patients were over 18 years old and fully capable of signing the informed consent. Proctoscopy or colonoscopy was performed in all patients before surgery. Laxative (YAL, RCT sol., Trommsdorff GmbH & Co. KG, Arzneimittel, Alsdorf) was applied an hour before the procedure. The preoperative protocol included information on age, height, weight, associated diseases, previous surgery or interventions on haemorrhoids, disease stage, subjective complaints – bleeding frequency (daily, weekly, monthly), pain (using a visual analogue scale, 0-10), prolapse, itching, mucus, necessity of analgesics. The surgery was performed under general, epidural or spinal anaesthesia. A transparent proctoscope (BEAK, Sapimed) was put in the anus and haemorrhoidal plexuses were detected visually. After having set the CelonLab PRECISION at the power level of 5 W the bipolar RFITT electrode was inserted after tumescence with saline solution into the haemorrhoidal nodes and extracted gradually. The progress of the coagulation was monitored via acoustic feedback as well as visually while extracting the RFITT applicator. Then followed, if necessary, application of the bipolar electrode into prolapsing haemorrhoids distally from the linea dentata. Patients were discharged on the same or next day. Outpatient care consisted of laxatives (Lactulosa Biomedica) + venotonics (Detralex, Les Laboratoires Servier, Neuilly-Sur-Seine, 3 × 2 tbl.) During the surgery day the patients were permanently monitored, local status was checked for bleeding and analgesics were applied according to the individual needs. Patients with urine retention were catheterised. The number of insertions of the RFITT applicator, the device output, the time for the intervention, and the application time associated with the RFITTH procedure (excisions, sphincter divulsion) were recorded after surgery. Post-surgery follow-up consisted of patients’ assessment of the symptoms such as bleeding (important, spotting through day, spotting only after stool), pain, patients’ satisfaction as well as objective assessment of clinically relevant symptoms such as oedema, haematoma, finding in per rectum examination. All patients were followed up in 7 and 21 day intervals after surgery. Local status was controlled and a rectum examination was performed during each visit. Oedema, pain and bleeding were recorded during each follow-up visit. All patients were examined again 6 months and 1 year after RFITTH using the same examination criteria. At the same time patients’ opinion regarding their satisfaction with RFITTH and their further recommendations were assessed. In January 2010 a final questionnaire was sent to all patients. 35% of all patients returned the questionnaire. Results are shown in .
The statistical assessment was performed in the Institute for Statistics and Bioanalysis of Tomas Bata University in Zlin, Czech Republic using SAS CATMODE procedure for Windows.