Radiofrequency treatment for haemorrhoids

The postoperative pain score (measured on a visual analogue scale of 0 to 10, where higher scores show more pain) in the first week after the procedure ranged from 0 to 2 for patients who had radiofrequency treatment and from 2 to 4 for patients who had rubber band ligation in a randomised controlled trial (RCT) of 80 patients. Duration of post-defaecation pain in the first week was 6 minutes in the radiofrequency treatment group compared with 13 minutes in the rubber band ligation group (p=0.01) in the same study. Pain in the anal region was reported in 12% (29/240) of patients in a case series of 240 patients. The pain intensity was scored 1 to 2 on the visual analogue scale and the patients were treated with analgesics. Anal pain (not further described) was reported in 7% (2/28) of patients who had radiofrequency treatment and 50% (16/32) of patients who had rubber band ligation in an RCT of 60 patients (p<0.05). Pain was reported by all patients in a case series of 50 patients; this subsided within 10 days after surgery in 43 patients and no patients complained of pain at the end of 1 month. Post-defaecation pain continued for 6 days after radiofrequency treatment and 13 days after haemorrhoidectomy in an RCT of 40 patients.

Bleeding after the procedure was reported in 19% (7/36) of patients who had radiofrequency treatment (reported mostly between 5 and 10 days after the procedure) and 5% (2/44) of patients who had rubber band ligation (reported between 7 and 9 days after the procedure) in the RCT of 80 patients. Bleeding, associated with defaecation, in the first 2 weeks was reported in 10% (23/240) of patients in the case series of 240 patients. Heavy bleeding in the first week after the procedure was reported in 2% (4/240) of patients in the same study; the bleeding was spontaneous and not associated with defaecation. The patients were admitted to hospital and 3 of the 4 had resolution of symptoms after conservative treatment. One patient needed to be examined under general anaesthesia; the active bleeding source was located and secured. Bleeding (not further described) was reported in 21% (6/28) of patients who had radiofrequency treatment and 13% (4/32) of patients who had rubber band ligation (p<0.05) in the RCT of 60 patients. Bleeding within 4 weeks of the procedure was reported in 14% (7/50) of patients in the case series of 50 patients; this was associated with defaecation and no treatment was needed. Post-defaecation bleeding continued for 7 days after radiofrequency treatment and for 24 days after haemorrhoidectomy in the RCT of 40 patients. Heavy bleeding, treated by a second procedure, was reported in 1 patient in a case series of 210 patients.

Urinary retention was reported in 4% (2/50) of patients in the case series of 50 patients; 1 patient had an enlarged prostate, the other had a large prolapsing haemorrhoid. It is thought that the treatment may have caused urethral spasm, leading to retention of urine. Both patients were catheterised, which relieved the symptoms. Urinary retention was reported in 1 patient in the case series of 210 patients; the patient had an enlarged prostate and was catheterised to relieve the symptoms.

Rectal tenesmus was reported in 6% (2/36) of patients who had radiofrequency treatment and 16% (7/44) of patients who had rubber band ligation (p=0.019) at 1‑week follow‑up in the RCT of 80 patients. Rectal tenesmus was reported in 4% (1/28) of patients who had radiofrequency treatment and 19% (6/32) of patients who had rubber band ligation (p<0.05) in the RCT of 60 patients.

Skin tag formation at 12‑month follow‑up was reported in 7 patients who had external haemorrhoids, in the case series of 50 patients.

In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, the specialist adviser did not list any additional anecdotal adverse events. They considered that the following were theoretical adverse events: infection and abscess.