经括约肌间瘘管结扎术治疗经括约肌肛瘘的多中心前瞻性研究

Multicenter prospective study of ligation of the intersphicteric fistula tract in the treatment of transsphincteric fistula

  • 摘要: 目的:探讨经括约肌间瘘管结扎术(LIFT)治疗经括约肌肛瘘的临床疗效。
    方法:采用前瞻性研究方法。选取2011年1月至2015年7月南京中医药大学第一附属医院(51例)、苏州市中医院 (38例)、南京中医药大学第三附属医院(30例)和徐州市中心医院(13例)收治的132例经括约肌肛瘘患者。采用随机数字表法将患者分为治疗组(行LIFT)和对照组(行肛瘘切开术或切开挂线术)。观察指标:(1)手术时间。(2)术后第1、3、7、14天肛门疼痛评分。(3)创面愈合时间。(4)术前、出院时、术后3、6、 12个月肛门失禁评分。(5)总治愈率。总治愈率=一期治愈率+局部切口失败率(经局部换药愈合)。采用门诊、问卷、电话方式进行随访。患者术后1个月至门诊复诊;术后3、6、12、24个月由随访人员问卷调查及电话随访,了解创面愈合情况、肛门控便能力及治愈情况。随访时间截至2015年12月。正态分布的计量资料以±s表示,组间比较采用t检验。偏态分布的计量资料以M(范围)表示,组间比较采用非参数检验。重复测量数据采用重复测量方差分析。计数资料比较采用x2检验。
    结果:筛选出符合研究条件的患者132例,治疗组67例,对照组65例。两组患者术前均无肛门失禁。治疗组67例患者均行LIFT;对照组65例患者中,45例行肛瘘切开术,20例行切开挂线术。(1)治疗组患者手术时间为(52±16)min,对照组为(49±17)min,两组比较,差异无统计学意义(t=-1.3,P>0.05)。(2)治疗组患者术后第1、3、7、14天肛门疼痛评分分别为1分(0~3分)、4分(1~6分)、2分(0~5分)、1分(0~4分),对照组分别为1分 (0~3分)、4分(1~7分)、4分(1~7分)、2分(0~6分),两组术后肛门疼痛评分变化趋势比较,差异有统计学意义(F=174.5,P<0.05)。其中术后第1、3天两组比较,差异均无统计学意义(Z=-0.3,-1.7,P>0.05);术后第7、14天两组比较,差异均有统计学意义(Z=-6.1,-3.3,P<0.05)。(3)治疗组创面愈合时间为29 d(19~55 d),对照组为38 d(19~85 d),两组比较,差异有统计学意义(Z=-4.6,P<0.05)。(4)治疗组患者出院时、术后3、6、12个月肛门失禁评分均为0分(0~2分),对照组分别为0分(0~4分)、0分(0~7分)、0分(0~5分)、0分(0~4分),两组术后肛门失禁评分变化趋势比较,差异有统计学意义(F=10.8,P<0.05)。其中出院时、术后3、6个月两组比较,差异均无统计学意义(Z=-1.8,-1.6, -1.4,P>0.05);术后12个月两组比较,差异有统计学意义(Z=-2.2,P<0.05)。(5)治疗组67例患者中,50例一期手术治愈,8例单纯性括约肌间切口感染(或裂开)经换药后治愈,9例复发经再次手术治疗后治愈,总治愈率为86.6%(58/67)。对照组65例患者中,61例一期手术治愈,4例复发经再次手术治疗后治愈,总治愈率为93.8%(61/65)。两组总治愈率比较,差异无统计学意义(χ2=1.2,P>0.05)。132例患者均获得术后随访。随访时间为5~59个月,中位随访时间为24个月。
    结论:LIFT作为临床治疗经括约肌肛瘘的保留全括约肌手术,术后疼痛轻、创面愈合时间短、肛门功能保护好。

     

    Abstract: Objective:To explore the clinical effect of ligation of the intersphicteric fistula tract (LIFT) in the treatment of transsphincteric fistula.
    Methods: The prospective study was conducted. The clinical data of 132 patients with transsphincteric fistula who were respectively admitted to the First Affiliated Hospital of Nanjing University of Chinese Medicine (51 patients), Suzhou Hospital of Chinese Medicine (38 patients), the Third Affiliated Hospital of Nanjing University of Chinese Medicine (30 patients) and Xuzhou Central Hospital (13 patients) between January 2011 and July 2015 were collected. All the patients were allocated into the treatment group (undergoing LIFT) and control group (undergoing fistulotomy or incisionthreaddrawing procedure) according to random number table. Observation indices: (1) operation time, (2) anal pain scores at postoperative day 1, 3, 7 and 14, (3) wound healing time, (4) anal incontinence scores before operation, at discharge and at postoperative month 3, 6 and 12, (5) total cure rate. Total cure rate=onestage cure rate+local incision failure rate (healing through local dressing change). The patients were followed up using outpatient examination, questionnaires and telephone interview up to December 2015. The outpatient examination was conducted at postoperative month 1, and questionnaires and telephone interview were performed to detect wound healing, anal control ability and healing situation at postoperative month 3, 6, 12 and 24. Measurement data with normal distribution were presented as ±s and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were presented as M (range) and comparison between groups was analyzed using the nonparametric test. Repeated measures data were analyzed by the repeated measures ANOVA, and count data were analyzed using chisquare test.
    Results:All the 132 patients who were screened for eligibility were randomly divided into the treatment group (67 patients) and control group (65 patients), without the occurrence of preoperative anal incontinence. Sixtyseven patients in the treatment group underwent LIFT, 45 and 20 patients in the control group respectively underwent fistulotomy and incisionthreaddrawing procedure. (1) Operation time in the treatment group and control group was (52±16)minutes and (49±17)minutes, with no statistically significant difference (t=-1.3, P>0.05). (2) Anal pain scores at postoperative day 1, 3, 7 and 14 were 1 (range, 0-3), 4 (range, 1-6), 2 (range, 0-5), 1 (range, 0-4) in the treatment group and 1 (range, 0-3), 4 (range, 1-7), 4 (range, 1-7), 2 (range, 0-6) in the control group, respectively, showing a statistically significant difference in the change trend of pain between the 2 groups (F=174.5, P<0.05)and at postoperative day 7 and 14 between 2 groups(Z=-6.1,-3.3, P<0.05), and showing no statistically significant difference at postoperative day 1 and 3 between 2 groups (Z=-0.3,-1.7, P>0.05). (3) Wound healing time in the treatment group and control group respectively was 29 days(range, 19-55 days)and 38 days(range, 19- 85 days), with a statistically significant difference between 2 groups (Z=-4.6, P<0.05). (4) Anal incontinence scores at discharge and at postoperative month 3, 6 and 12 respectively were 0 (range, 0-2), 0 (range, 0-2), 0 (range, 0-2), 0 (range, 0-2) in the treatment group and 0 (range, 0-4), 0 (range, 0-7), 0 (range, 0-5), 0 (range, 0-4) in the control group, respectively, showing a statistically significant difference in the change trend of anal incontinence scores between the 2 groups (F=10.8, P<0.05) and at postoperative month 12 between the 2 groups (Z=-2.2, P<0.05), and showing no statistically significant difference at discharge and at postoperative month 3 and 6 between the 2 groups (Z=-1.8,-1.6,-1.4, P>0.05). (5) Among 67 patients in the treatment group, 50 were cured through onestage operation, 8 with sphincteric incision infection (or dehiscence) were cured through dressing change, 9 with recurrence were cured using reoperations, and total cure rate was 86.6%(58/67). Among 65 patients in the control group, 61 were cured through onestage operation,4 with recurrence were cured through reoperations, and total cure rate was 93.8%(61/65). There was no statistically significant difference in the total cure rate between the 2 groups (χ2=1.2, P>0.05). All the 132 patients were followed up for 5-59 months with a median time of 24 months.
    Conclusion:LIFT in the treatment of transsphincteric fistula has the advantages of sphincterpreserving, postoperative mild pain, shorter wound healing time and better anal control ability.

     

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