Cryotherapy reduces pain post-hemorrhoidectomy (CYPHER): a randomized, controlled, superiority trial of intra-anal ice after surgery for grade III hemorrhoids

다국어 초록 (Multilingual Abstract)

Purpose: We aimed to determine whether intra-anal cryotherapy reduces postoperative pain in patients undergoing hemorrhoidectomy.
Methods: This randomized controlled trial was conducted from January 2023 to August 2024. Patients with symptomatic grade III hemorrhoids were randomized 1:1 to receive either 1 minute of intra-anal cryotherapy or standard postoperative care. Because cryotherapy was applied before reversal of general anesthesia, patients were blinded to treatment allocation. The primary outcome was pain at rest on postoperative day (POD) 1. Secondary outcomes included pain after defecation, time to return to work or non-work activities, 30-day complications, and compliance with analgesia. Pain was measured using the visual analog scale.
Results: A total of 50 patients were randomized (25 per group). All 50 were included in the analysis. Baseline clinicodemographic characteristics were comparable between groups. The primary outcome, POD 1 pain at rest, did not demonstrate superiority of cryotherapy compared with standard care (median 3.0 vs. 4.0, P=0.062). However, the POD 1 pain score after defecation was significantly lower with cryotherapy than without (3.0 vs. 4.0, P=0.046). On POD 2, median pain scores at rest and after defecation were both significantly lower in the cryotherapy cohort (at rest: 2.0 vs. 4.0, P=0.043; after defecation: 2.0 vs. 5.0, P=0.001).
Conclusion: Intra-anal cryotherapy significantly reduces pain after defecation in the early postoperative period following surgery for grade III hemorrhoids. Its therapeutic efficacy, ease of application, and safety support consideration for routine use.Trial registration ClinicalTrials.gov identifier: NCT06005727