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 Single-facet injury during the procedure was reported in the first 3 patients in a case series of 400 patients with lumbar disc herniation treated by percutaneous interlaminar endoscopic lumbar discectomy (no further details provided).

5.2 Dural injury was reported in 1 patient who had recurrent lumbar disc herniation after conventional discectomy, treated by interlaminar endoscopic lumbar discectomy in a prospective comparative study of 100 patients treated by full-endoscopic discectomy (interlaminar approach, n=29; transforaminal approach, n=21) or microsurgical discectomy (n=50); it was repaired with fibrin glue. Dural injury was reported in none of the patients in the transforaminal group and in 6% (3/50) of patients in the microsurgical group (no further details provided). Minor dural tear was reported in 2% (7/400) of patients in the case series of 400 patients (no further details provided). Dural tear was reported in 6% (6/104) of procedures using the interlaminar approach in a case series of 163 patients (175 procedures) with lumbar disc herniations treated by interlaminar or transforaminal endoscopic lumbar discectomy. In 5 procedures, patients were treated conservatively with 2 additional days of bed rest before mobilisation and discharge. In 1 procedure, an attempt was made to repair the dura by open surgery immediately after the procedure; this was complicated by an open cerebrospinal fluid fistula. The patient needed a second procedure to repair the dura and 5 days of bed rest and lumbar drainage.

5.3 Nerve root injury and persistent paraesthesia 2 years after the procedure were reported in 1 patient in the case series of 400 patients (no further details provided).

5.4 Motor deficit was reported in 3% (5/163) of patients (interlaminar approach, n=104 procedures; transforaminal approach, n=71 procedures) in the case series of 163 patients. In 2 of these 5 patients, 2‑level discectomy was performed using an interlaminar approach for 1 level and a transforaminal approach for 1 level. In 4 patients these motor deficits were transient and they recovered completely, including the 2 patients who were treated by 2‑level discectomies. In 1 patient there was a permanent motor deficit resulting in footdrop (no further details provided).

5.5 Transient dysaesthesia was reported in 3% (2/59) of patients with symptomatic lumbar disc herniation treated by interlaminar endoscopic lumbar discectomy in a prospective comparative study of 200 patients treated by full-endoscopic discectomy (interlaminar approach, n=59; transforaminal approach, n=41) or microsurgical discectomy (n=100). In the transforaminal group and in the microsurgical group, transient dysaesthesia was reported in 2% (1/41) and 5% (5/100) respectively (no further details provided). Transient dysaesthesia was reported in 6% (2/29) of patients who had recurrent lumbar disc herniation after conventional discectomy, treated by interlaminar endoscopic lumbar discectomy, in the prospective comparative study of 100 patients treated by full‑endoscopic discectomy or microsurgical discectomy; it was reported in none of the patients in the transforaminal group and in 10% (5/50) in the microsurgical group (no further details provided). Dysaesthesia was reported in 7% (2/30) of patients with symptomatic lumbar disc herniation treated by interlaminar endoscopic lumbar discectomy and in none of the 30 patients treated by the transforaminal approach in a retrospective comparative study of 60 patients (no further details provided). Transient dysaesthesia was reported in 3 patients treated by interlaminar endoscopic lumbar discectomy in a case series of 372 patients with symptomatic lumbar disc herniation (no further details provided).

5.6 Discitis was reported in 1% (2/400) of patients after the procedure in the case series of 400 patients; both patients were treated conservatively (no further details provided).

5.7 Pseudocysts were reported in 3% (9/298) of procedures in the group of patients treated by interlaminar endoscopic lumbar discectomy and in 1% (6/1205) of procedures in the group of patients treated by the transforaminal approach, in a case series of 1,406 patients with protruded or extruded disc materials compressing the lumbar root (p=0.001 for the comparison between groups). The interval between discectomy and pseudocyst detection on MRI was a mean of 53.7 (11–118) days. Five pseudocysts were treated surgically and 10 were treated conservatively.

5.8 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 advisers did not report any anecdotal adverse events. They considered that the following were theoretical adverse events: bleeding, haematoma and scar tissue.

  • National Institute for Health and Care Excellence (NICE)