Department of Surgery, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Tech Coloproctol. 2013 Apr;17(2):181-6. doi: 10.1007/s10151-012-0894-6. Epub 2012 Sep 15.
Idiopathic chronic anal fissure is believed to be a consequence of a traumatic acute anodermal tear followed by recurrent inflammation and poor healing due to relative tissue ischaemia secondary to internal sphincter spasm. This pilot trial compared the efficacy of a novel manufactured ano-coccygeal support attached to a standard toilet seat (Colorec) to the standard procedure of lateral internal sphincterotomy (LIS) for chronic anal fissure.
Fifty-three patients with confirmed chronic anal fissures were enrolled and assigned, based on their preference, to the test group and the control group. Each patient was reviewed after therapy, and follow-up was scheduled at 4, 6 and 8 weeks and at 6 months.
The fissure healing rate was 100% in both groups. There were no statistically significant differences between the test group (n = 30, median age 42 years; range 20-71 years) and the control group (n = 22, median age 38 years; range 23-60 years) with regards to resolution of rectal bleeding at defaecation after 4 weeks (86.6 vs. 72.7%, p = 0.698), and by week 6, bleeding had resolved in 100% of patients in both groups. There was no statistically significant difference between the test group and the control group with regards to pain scores at 4, 6 and 8 weeks (4.30 ± 0.79, 2.03 ± 0.80, 0.43 ± 0.50 vs. 3.50 ± 0.74, 1.68 ± 0.56, 0.50 ± 0.51, p = 0.054) and to time until complete healing of fissures (5.60 ± 1.52 weeks vs. 5.91 ± 1.57 weeks, p = 0.479). After continuous use of the ano-coccygeal support over 6 months, no patients in the test group had recurrent fissures. No complications were observed during the trial.
Results of both methods were comparable and demonstrated that the ano-coccygeal support is at least as effective as LIS, without any short-term complications. Larger and randomised trials on the use of ano-coccygeal support for chronic anal fissures are awaited.
特发性慢性肛裂被认为是由于急性肛门皮肤撕裂伤后反复发作的炎症和愈合不良导致的，这是由于内括约肌痉挛引起的相对组织缺血所致。本试验比较了新型肛尾支撑装置（Colorec）与传统的括约肌切开术（LIS）治疗慢性肛裂的疗效。
53 例确诊为慢性肛裂的患者根据其意愿被分为试验组和对照组。每位患者在治疗后进行评估，并在 4、6 和 8 周及 6 个月时进行随访。
两组的肛裂愈合率均为 100%。试验组（n=30，中位年龄 42 岁；范围 20-71 岁）和对照组（n=22，中位年龄 38 岁；范围 23-60 岁）在 4 周时排便时直肠出血缓解方面无统计学差异（86.6% vs. 72.7%，p=0.698），并且在 6 周时两组患者均完全缓解出血。两组在 4、6 和 8 周时的疼痛评分（4.30±0.79、2.03±0.80、0.43±0.50 vs. 3.50±0.74、1.68±0.56、0.50±0.51，p=0.054）和肛裂完全愈合时间（5.60±1.52 周 vs. 5.91±1.57 周，p=0.479）方面均无统计学差异。在试验过程中，试验组在持续使用肛尾支撑装置 6 个月后，无患者出现肛裂复发。
两种方法的结果相当，表明肛尾支撑装置至少与 LIS 同样有效，且无短期并发症。需要进行更大规模和随机的试验来评估肛尾支撑装置治疗慢性肛裂的效果。
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