Popeskou Sotirios Georgios, Pravini Barbara, Panteleimonitis Sofoklis, Vajana Antoniacopo Ferrario Di Tor, Vanoni Alice, Schmalzbauer Mike, Posabella Alberto, Christoforidis Dimitri
Department of Visceral Surgery and Transplantation, Geneva University Hospitals, Geneva, Switzerland.
Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.
Int J Colorectal Dis. 2020 Jul;35(7):1193-1199. doi: 10.1007/s00384-020-03551-9. Epub 2020 Mar 6.
Pilonidal sinus disease (PD) is a common acquired disease, responsible for discomfort and time off work. There is currently no consensus on the best surgical therapy. We aimed at comparing conservative sinusectomy (S) to excision and paramedian primary closure (PC).
This is a randomized controlled trial compatible with the CONSORT statement standards. We included all patients with chronic PD between 2012 and 2017. We excluded patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps. Patients with chronic symptomatic PD were randomized to S or PC. Primary end-point was the rate of patients healed at 3 weeks, secondary outcomes were total healing time, pain, time off work, patient satisfaction and recurrence at 1 year. Patients were seen at a wound clinic until healed and contacted at 3, 6, and 12 months for follow-up.
After inclusion of 58 patients the study was stopped prematurely due to discrepancy between expected and observed outcomes. Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01). Median time to complete healing was 54 (23-328) days in the S group compared to 34 (13-141) in the PC group (p = 0.025). Number of outpatient visits, time off work, analgesia requirement, and recurrence rates at 12 months 4 (16%) in the S group and 3 (11.1%) in the PC group (p = 0.548) were similar.
PC leads to faster healing compared to S, with similar healthcare burden.
The study was approved by the local ethics committee and registered in www.clinicaltrials.gov (REF: NCT03271996). The study was carried out at the Regional Hospital of Lugano, Switzerland.
藏毛窦疾病（PD）是一种常见的后天性疾病，会导致不适和误工。目前对于最佳手术治疗方法尚无共识。我们旨在比较保守性窦道切除术（S）与切除加旁正中一期缝合术（PC）。
这是一项符合CONSORT声明标准的随机对照试验。我们纳入了2012年至2017年间所有慢性PD患者。我们排除了患有急性脓肿的患者、手术有治愈意图后复发性PD患者以及需要用旋转皮瓣进行复杂重建的患者。慢性症状性PD患者被随机分为S组或PC组。主要终点是3周时愈合的患者比例，次要结局是总愈合时间、疼痛、误工时间、患者满意度和1年时的复发率。患者在伤口诊所就诊直至愈合，并在3、6和12个月时进行随访。
纳入58例患者后，由于预期结果与观察结果存在差异，研究提前终止。S组30例患者中只有4例（13.3%）在3周时完全愈合，而PC组28例患者中有14例（50%）（p = 0.01）。S组完全愈合的中位时间为54（23 - 328）天，而PC组为34（13 - 141）天（p = 0.025）。S组的门诊就诊次数、误工时间、镇痛需求以及12个月时的复发率为4例（16%），PC组为3例（11.1%）（p = 0.548），两者相似。
与S相比，PC愈合更快，医疗负担相似。
该研究经当地伦理委员会批准，并在www.clinicaltrials.gov上注册（参考号：NCT03271996）。该研究在瑞士卢加诺地区医院进行。
