骶尾部藏毛窦疾病中采用窦道苯酚化的病灶切除术与根治性切除术的比较：一项单中心随机对照试验的研究方案
Pit excision with phenolisation of the sinus tract versus radical excision in sacrococcygeal pilonidal sinus disease: study protocol for a single centre randomized controlled trial.
作者信息
Furnée Edgar J B, Davids Paul H P, Pronk Apollo, Smakman Niels
机构信息
Diakonessenhuis, Department of Surgery, Bosboomstraat 1, P.O. Box 80250, 3508 TG, Utrecht, Netherlands.
出版信息
Trials. 2015 Mar 14;16:92. doi: 10.1186/s13063-015-0613-5.
BACKGROUND
Excision of the pit of the sinus with phenolisation of the sinus tract and surgical excision are two treatment modalities for patients with sacrococcygeal pilonidal sinus disease. Phenolisation seems to have advantages over local sinus excision as it is performed under local anaesthesia with a relatively small surgical procedure, less postoperative pain, minor risk of surgical site infection (8.7%), and only a few days being unable to perform normal activity (mean of 2.3 days). The disadvantage may be the higher risk of recurrence (13%) and the necessity to perform a second phenolisation in a subgroup of patients. Wide surgical excision of sacrococcygeal pilonidal sinus disease has a recurrence rate of 4 to 11%. The disadvantages, however, are postoperative pain, high risk of surgical site infection, and a longer period being unable to perform normal activity (mean of 10 days). The objective of this study is to show that excision of the pit of the sinus of sacrococcygeal pilonidal sinus disease with phenolisation of the sinus tract is a successful first-time treatment modality for sacrococcygeal pilonidal sinus disease accompanied by a quicker return to normal daily activity compared to local excision of the sinus.
METHODS/DESIGN: Patients with sacrococcygeal pilonidal sinus disease will be randomly allocated to excision of the pit of the sinus followed by phenol applications of the sinus tract or radical surgical excision of the sinus. Patients are recruited from a single Dutch teaching, non-university hospital. The primary endpoint is loss of days of normal activity/working days. Secondary endpoints are anatomic recurrence rate, symptomatic recurrence rate, quality of life, surgical site infection, time to wound closure, symptoms related to treatment, pain, usage of pain medication and total treatment time. To demonstrate a reduction of return to normal activity from 7.5 days in the excision group to 4 days in the phenolisation group, with 80% power at 5% alpha, a total sample size of 100 is required.
DISCUSSION
This study is a randomised controlled trial to provide evidence that phenolisation of the sinus tract compared to radical excision reduces the total number of days unable to perform normal activity.
TRIAL REGISTRATION
Dutch trial register NTR4043 , registered on 24 June 2013.
背景
切除骶尾部藏毛窦的窦口并对窦道进行石炭酸处理以及手术切除是治疗骶尾部藏毛窦疾病患者的两种治疗方式。与局部窦道切除相比，石炭酸处理似乎具有优势，因为它在局部麻醉下进行，手术操作相对较小，术后疼痛较轻，手术部位感染风险较低（8.7%），并且仅需几天无法进行正常活动（平均2.3天）。缺点可能是复发风险较高（13%），并且在一部分患者中需要进行第二次石炭酸处理。广泛手术切除骶尾部藏毛窦疾病的复发率为4%至11%。然而，缺点是术后疼痛、手术部位感染风险高以及无法进行正常活动的时间较长（平均10天）。本研究的目的是表明，与局部切除窦道相比，切除骶尾部藏毛窦疾病的窦口并对窦道进行石炭酸处理是一种成功的首次治疗方式，并且能更快恢复正常日常活动。
方法/设计：患有骶尾部藏毛窦疾病的患者将被随机分配接受切除窦口并随后对窦道进行石炭酸处理或对窦道进行根治性手术切除。患者从一家荷兰教学型非大学医院招募。主要终点是正常活动天数/工作日的损失。次要终点是解剖学复发率、症状性复发率、生活质量、手术部位感染、伤口闭合时间、与治疗相关的症状、疼痛、止痛药的使用以及总治疗时间。为了证明正常活动恢复时间从切除组的7.5天减少到石炭酸处理组的4天，在5%的α水平下具有80%的检验效能，总共需要100个样本量。
讨论
本研究是一项随机对照试验，旨在提供证据表明与根治性切除相比，窦道石炭酸处理可减少无法进行正常活动的总天数。
试验注册
荷兰试验注册NTR4043，于2013年6月24日注册。
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