Cold versus hot haemostasis in tonsillectomy: impact on post-tonsillectomy haemorrhage and pain perception - results from a randomized clinical trial
摘要
The purpose of this study was to compare cold and hot haemostasis techniques during tonsillectomy in terms of the posttonsillectomy haemorrhage (PTH) risk and patient-reported postoperative pain. The primary objective was to compare the incidence of PTH from the cold- versus hot-haemostasis-treated tonsillar bed within 30 days. The secondary objective was to compare pain perception between the two sides.
MethodsThis was a randomized, interventional, single-centre, self-controlled clinical trial that included adolescents (aged ≥ 12 years) who underwent tonsillectomy at Nordsjællands Hospital, Denmark. Patients with malignancies, peritonsillar abscess, or coagulopathies as well as those treated with anticoagulants were excluded. Each patient received cold haemostasis (cold steel dissection and knot ligation with compression) on one tonsillar bed and hot haemostasis (cold steel dissection and bipolar diathermy, 15 W) on the contralateral side; with this method, patients served as their own controls.
ResultsAmong the 381 included patients, 188 (49%) completed each protocol (cold/hot). Primary PTH (≤ 24 h after surgery) occurred in 12 patients (6.4%), with 6 cases of bleeding only from the cold-treated side, 3 from both sides and in 3 cases laterality was unknown (p ≤ 0.0014; OR 13.0; 95% CI 1.5–113). Secondary PTH occurred in 54 patients (29%), and of these, 33 were managed at home and 21 were admitted. Among the admitted patients, 12 bled only from the hot-treated side and 4 from the cold-treated side (p = 0.049; OR 0.33; 95% CI 0.093–0.994). More patients reported greater pain on the hot-treated side on days 12 (81%; 95% CI 73–88%) and 30 (79%; 95% CI: 65–90%) than on the cold-treated side.
ConclusionCompared with hot haemostasis, cold haemostasis is associated with a greater risk of primary PTH but significantly lower risks of secondary PTH and postoperative pain. Cold haemostasis was feasible in 49% of the patients.
Trial registrationRegional Ethics Committee: H-20036864. ClinicalTrials.gov Identifier: NCT05161754.