Optimal drainage time after evacuation of chronic subdural haematoma (DRAIN TIME 2): a multicentre, randomised, multiarm and multistage non-inferiority trial in Denmark.

BACKGROUND: Postoperative drainage after surgical evacuation of chronic subdural haematoma reduces the risk of recurrence, but the optimum drainage time is uncertain. We aimed to investigate the shortest possible drainage time without increasing the haematoma recurrence rate. METHODS: We conducted a randomised, multi-arm and multistage non-inferiority trial at four neurosurgical centres in Denmark. We enrolled adult patients (aged ≥18 years) with symptomatic chronic subdural haematoma. All patients were treated according to the national standard practice with a burr hole above the maximum width of the haematoma. Patients were randomly assigned in a 1:1:1 ratio via a centralised web server to receive 6 h, 12 h, or 24 h of postoperative passive subdural drainage. Randomisation was done by an independent on-call neurosurgeon and was masked until 6 h after surgery. The primary outcome was symptomatic haematoma recurrence at 3 months after surgery; the rate of recurrence was assessed in a regression model for non-inferiority testing, with no missing data. Personnel assessing the primary outcome were masked to group allocation. Non-inferiority was assessed with a prespecified margin of 7%, in a modified intention-to-treat population-defined as patients with randomly assigned treatment excluding those withdrawing from study participation after randomisation, or experiencing acute rebleedings or accidental drain removal. This trial is registered with ISRCTN (number 15186366); the trial was stopped after the first interim analysis on the advice of an independent safety advisory committee. FINDINGS: Between March 1, 2021, and June 30, 2022, 347 patients were enrolled and 331 were followed up to 3 months, 105 were assigned to 6 h of drainage, 111 to 12 h of drainage, and 115 to 24 h of drainage. At admission, 83 (25%) participants were women and 248 (75%) were men, mean age was 75·7 years (SD 10·5), median modified Rankin Scale score was 4 (IQR 3-5), and median Glasgow Coma Scale score was 15 (IQR 14-15). At 3 months after surgery, haematoma recurrence was reported in 28 (27%) of 105 patients who were assigned to 6 h drainage (predicted haematoma recurrence rate 27·0%, 95% CI 18·5 to 35·4), 22 (20%) of 111 assigned to 12 h drainage (19·5%, 12·0 to 27·0), and 12 (10%) of 115 assigned to 24 h drainage (10·4%, 4·8 to 16·0). The risk of haematoma recurrence was increased by 16·5 percentage points (95% CI 6·5 to 26·6) in patients drained for 6 h compared with 24 h, and by 9·1 percentage points (-0·4 to 18·5) in patients drained for 12 h compared with 24 h. Therefore, non-inferiority of 6 h and 12 h of drainage to 24 h of drainage was not established. 20 patients had died by 3 months, seven in the 6 h group, eight in the 12 h group, and five in the 24 h group. The most frequent known causes of death were haematoma recurrence (three in 12 h group), comorbidity (three in 12 h group), and pneumonia (one each in 6 h and 12 h groups, two in 24 h group). The most frequent complication was postoperative infection, reported in 20 (20%) patients in the 6 h group, 25 (23%) in the 12 h group, and 19 (17%) in the 24 h group. The most common infection source was the urinary tract. INTERPRETATION: Patients surgically treated for symptomatic chronic subdural haematoma and postoperatively drained for 6 h or 12 h had higher rates of haematoma recurrence than did patients drained for 24 h. The findings from this non-inferiority trial provide evidence to support 24 h of postoperative drainage as the standard drain time when a fixed drain time approach is used. To provide solid evidence of generalisability of the results to countries other than Denmark, a multinational randomised controlled trial will be needed. FUNDING: None.

Lumbar percutaneous transforaminal endoscopic discectomy: a retrospective survey on the first 172 adult patients treated in Denmark.

PURPOSE: To evaluate patient demographics, surgery characteristics, and patient-reported clinical outcomes related to the implementation of lumbar PTED in Denmark by surgeons novice to the PTED technique. METHODS: All adult patients treated with a lumbar PTED from our first surgery in October 2020 to December 2021 were included. Data was generated by journal audit and telephone interview. RESULTS: A total of 172 adult patients underwent lumbar PTED. Surgery duration was a median of 45.0 (35.0-60.0) minutes and patients were discharged a median of 0 (0-1.0) days after. Per operatively one procedure was converted to open microdiscectomy due to profuse bleeding. Post operatively one patient complained of persistent headache (suggestive of a dural tear), two patients developed new L5 paresthesia, and three patients had a newly developed dorsal flexion paresis (suggestive of a root lesion). Sixteen patients did not complete follow-up and 24 (14.0%) underwent reoperation of which 54.2% were due to residual disk material. Among the remaining 132 patients, lower back and leg pain decreased from 7.0 (5.0-8.5) to 2.5 (1.0-4.5) and from 8.0 (6.0-9.1) to 2.0 (0-3.6) at follow-up, respectively (p < 0.001). Additionally, 93.4% returned to work and 78.8% used less analgesics. Post hoc analysis comparing the early half of cases with the latter half did not find any significant change in surgery time, complication and reoperation rates, nor in pain relief, return to work, or analgesia use. CONCLUSION: Clinical improvements after lumbar PTED performed by surgeons novel to the technique are satisfactory, although the reoperation rate is high, severe complications may occur, and the learning curve can be longer than expected.