背景:先前的研究主要集中在肛瘘治疗的手术结果,比如治愈率,而不是患者报告的结果,如术后疼痛,这可能会影响手术选择。
目的:比较激光闭合和括约肌间结扎术治疗肛瘘术后6和24h的疼痛评分。
方法:前瞻性,双盲随机对照试验。
方法:马来西亚一家四级医院。
方法:年龄在18-75岁的经括约肌高位瘘患者。
方法:瘘管激光闭合与瘘管道结扎(LIFT)治疗。
方法:疼痛评分,尿失禁,生活质量(QOL),手术时间,使用卡方比较治疗失败,费希尔的精确检验,学生t检验,或Mann-Whitney,p<0.05表示有统计学意义。
结果:招募了56名患者(激光,n=28,LIFT,n=28)。术后6小时激光与LIFT的疼痛评分中位数分别为1.0和2.0(休息,p=0.213)和3.0对4.0(运动,p=0.448),分别。在24小时,这减少到2.5在两个手臂在休息(p=0.842),但增加到4.8与3.5在运动(p=0.383)。激光的中位手术时间(32.5分钟)明显短于LIFT(p<0.001)。激光治疗的患者倾向于更快地恢复工作(10.5vs.14.0,p=0.181),但治疗失败相似(54%与50%,p=0.71)。没有患者出现术后尿失禁。平均SF-36评分较基线增加(67.1±17.0;95%CI63.6-82.4vs.71.3±11.4;95%CI64.0-75.0)至术后6个月(77.7±21.0;95%CI57.0-80.3vs.74.0±14.3;95%CI67.6-81.4),与手术类型无关(P>0.05)。
结论:既往瘘管手术的患者(约20%)导致异质性。递送的总激光能量根据瘘管解剖结构而变化。
结论:激光瘘管闭合是LIFT的替代方法,具有相似的术后疼痛和更短的手术时间,尽管在激光臂中更复杂的瘘管解剖,生活质量有了更大的提高。
背景:ClinicalTrials.gov:NCT06212739。
BACKGROUND: Prior studies focus primarily on surgical outcomes of anal fistula treatment, such as healing rates, rather than patient-reported outcomes, such as postoperative pain, which could influence surgical choice.
OBJECTIVE: To compare pain scores at 6 and 24 h postoperatively between laser closure and ligation of the intersphincteric tract for anal fistula.
METHODS: Prospective, double-blinded randomized controlled trial.
METHODS: A quaternary hospital in Malaysia.
METHODS: Patients aged 18-75 years with high transsphincteric fistulas.
METHODS: Fistula laser closure versus ligation of the fistula tract (LIFT) treatment.
METHODS: Pain scores, continence, quality of life (QOL), operative time, and treatment failure were compared using chi-square, Fisher\'s exact test, student t-test, or Mann-Whitney with p < 0.05 denoting statistical significance.
RESULTS: Fifty-six patients were recruited (laser, n = 28, LIFT, n = 28). Median pain scores for laser versus LIFT at 6 h postoperatively were 1.0 versus 2.0 (Rest, p = 0.213) and 3.0 versus 4.0 (Movement, p = 0.448), respectively. At 24 h, this reduced to 2.5 in both arms at rest (p = 0.842) but increased to 4.8 versus 3.5 on movement (p = 0.383). Median operative time for laser was significantly shorter (32.5 min) than LIFT (p < 0.001). Laser treated patients trended toward quicker return to work (10.5 vs. 14.0, p = 0.181) but treatment failure was similar (54% vs. 50%, p = 0.71). No patients developed postoperative incontinence. Mean SF-36 scores increased from baseline (67.1 ± 17.0; 95% CI 63.6-82.4 vs. 71.3 ± 11.4; 95% CI 64.0-75.0) to 6 months postoperatively (77.7 ± 21.0; 95% CI 57.0-80.3 vs. 74.0 ± 14.3; 95% CI 67.6-81.4) regardless of the type of surgery (P > 0.05).
CONCLUSIONS: Patients with prior fistula surgery (approximately 20%) led to heterogeneity. The total laser energy delivered varied depending on fistula anatomy.
CONCLUSIONS: Laser fistula closure is an alternative to LIFT, with similar postoperative pain and shorter operative time despite more complex fistula anatomy in the laser arm, with a greater improvement in QOL.
BACKGROUND: ClinicalTrials.gov: NCT06212739.