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随机临床试验以测试骶尾部藏毛窦疾病的苯酚化。

Randomised clinical trial to test the phenolization in sacrococcygeal pilonidal disease.

机构信息

General and Digestive Surgery Department, University Hospital of Tarragona Joan XXIII, Rovira i Virgili University, Tarragona, Spain.

Research Department, Institut d'investigació Sanitaria Pere Virgili (IISPV), Tarragona, Spain.

出版信息

Int Wound J. 2023 Aug;20(6):2181-2189. doi: 10.1111/iwj.14096. Epub 2023 Jan 26.

Abstract

To test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease (SPD) the phenolization in uncomplicated SPD is feasible and secure in selected patients in observational studies. The greatest benefits are obtained to reduce the length of sick leave (LSL) and complications. Single-center randomised controlled clinical trial. Patients were recruited at University Hospital of Tarragona Joan XXIII of Spain. Patients were randomised into two treatment groups. All patients with uncomplicated sacrococcygeal disease, localised in the midline and with only 1 fistulous orifice. The patients were randomly assigned to the phenolization group (PhG) or conventional-surgery group (CsG). Both groups were managed without admission. The main endpoint was the recurrence of sacrococcygeal disease. Secondary endpoints included time of sick leave, complications, and readmission. 124 patients were included in the study. No disease recurrence was observed in either group. Clinical follow-up was carried out with a mean of 493.8 days (SD 6.59). The LSL was shorter in the PhG (mean 19.63 days, SD 28.15) than in the CSG (43.95 days, SD 38.60). The LSL reduction was -24.31 days (P .002). The phenolization in selected SPD is a safe and feasible procedure in selected patients. This approach could become the standard of care for patients with selected Sacrococcygeal pilonidal.

摘要

为了测试苯酚疗法治疗单纯性尾骨直肠部藏毛窦病(SPD)的疗效和安全性,在观察性研究中,选择合适的患者进行单纯性 SPD 的苯酚疗法是可行且安全的。苯酚疗法最大的益处是可以减少病假时间(LSL)和并发症。单中心随机对照临床试验。患者在西班牙塔拉戈纳 Joan XXIII 大学医院招募。患者随机分为两组治疗。所有患有单纯性骶尾部疾病的患者,病变局限于中线,仅有 1 个瘘管或开口。将患者随机分配到苯酚组(PhG)或常规手术组(CsG)。两组患者均无需住院治疗。主要终点是骶尾部疾病复发。次要终点包括病假时间、并发症和再入院。共有 124 名患者纳入研究。两组均未观察到疾病复发。临床随访平均为 493.8 天(SD 6.59)。苯酚组的病假时间更短(平均 19.63 天,SD 28.15),而常规手术组为 43.95 天(SD 38.60)。苯酚组的病假时间减少了 24.31 天(P.002)。在选择的 SPD 患者中,苯酚疗法是一种安全可行的方法。这种方法可能成为选择骶尾部藏毛窦病患者的标准治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0071/10333023/14d06b4f47d9/IWJ-20-2181-g001.jpg

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