Clinical Research Directory

ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY

In a study involving neurosurgeons worldwide, it was reported that most surgeons preferred the use of drains (186, 80.5%) and subfascial drains (169, 73.2%), with 52.87% of surgeons discontinuing drains based on time and 27.7% based on drainage volume (Cabrera et al. 2025). While the Enhanced Recovery After Surgery (ERAS) protocol does not recommend routine wound drainage for short-segment lumbar fusion surgery (Evidence Level Moderate, Recommendation Strength), the timing of drainage termination is based on drainage output (if drainage is below 50 ml) or based on postoperative days (day 2) (Han et al., 2024; Smith et al., 2019). We believe that further studies are needed to determine which patient groups require drains preoperatively and how long drains should remain in place postoperatively. This study, which aims to predict the amount of drainage during the perioperative period, will attempt to predict both the selective use of drains and how long to wait before discontinuing drainage in patients with drains. Lumbar subcutaneous fat thickness, previously used as a predictor of surgical site infections, will be tested for the first time in our study to determine whether it is a predictor of drainage output.

A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma

Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking. The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH. The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years. Ethics approval for inclusion of competent patients has been obtained (N-20240009).

Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy

Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.