5 Safety

5 Safety

This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1

Transient mild motor paralysis was reported in 1 patient from the discectomy group (n=32) in a non-randomised comparative study of 57 patients treated by endoscopic adhesiolysis, foraminoplasty and discectomy or endoscopic adhesiolysis and foraminoplasty without discectomy. Symptoms resolved 1 month after the procedure. Foot drop was reported in 3% (2/78) of patients in the discectomy group in a non-randomised comparative study of 98 patients treated by endoscopic adhesiolysis, foraminoplasty and discectomy (n=78) or endoscopic adhesiolysis and foraminoplasty without discectomy (n=20). Symptoms resolved within 6 months.

5.2

Transient hyperaesthesia was reported in 1 patient in the non-randomised comparative study of 98 patients. The authors did not state which group this patient was in. Paraesthesia was reported in 19% (15/78) of patients treated by endoscopic adhesiolysis, foraminoplasty and discectomy in the same study; symptoms resolved within 6 months.

5.3

Transient headaches were reported in 8% (8/98) and 5% (3/57) of patients in the 2 non-randomised comparative studies of patients treated by endoscopic adhesiolysis, foraminoplasty and discectomy or endoscopic adhesiolysis and foraminoplasty without discectomy. The authors did not state which groups these patients were in. Headache was reported in 1% (3/250) of patients in a case series of 250 patients.

5.4

Epidural pneumocephalus was reported in 1 patient in the case series of 250 patients (no further information given).

5.5

Focal infection was reported in 2% (2/98) and 4% (2/57) of patients in the 2 non-randomised comparative studies of patients treated by endoscopic adhesiolysis, foraminoplasty and discectomy or endoscopic adhesiolysis and foraminoplasty without discectomy. The authors did not state which groups these patients were in.

5.6

Meningitis was reported in 1 patient each in the 2 non-randomised comparative studies of patients treated by endoscopic adhesiolysis, foraminoplasty and discectomy or endoscopic adhesiolysis and foraminoplasty without discectomy. The authors of the studies did not state which treatment groups these patients were in. Symptoms resolved after bed rest and symptomatic treatment.

5.7

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, specialist advisers reported no anecdotal adverse events. They considered that the following were theoretical adverse events: cauda equina syndrome, spinal fluid leak, and epidural haematoma.