激光瘘管闭合术与括约肌间瘘管结扎术后疼痛的比较：一项前瞻性双盲随机对照试验。

Postoperative pain following laser fistula closure versus ligation of the intersphincteric fistula tract: A prospective double-blinded randomized controlled trial.

机构信息

Department of Surgery, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.

出版信息

World J Surg. 2024 Aug;48(8):1990-1999. doi: 10.1002/wjs.12242. Epub 2024 Jun 6.

DOI:10.1002/wjs.12242

PMID:38844401

Abstract

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.

DESIGN

Prospective, double-blinded randomized controlled trial.

SETTINGS

A quaternary hospital in Malaysia.

PATIENTS

Patients aged 18-75 years with high transsphincteric fistulas.

INTERVENTION

Fistula laser closure versus ligation of the fistula tract (LIFT) treatment.

MAIN OUTCOME MEASURES

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).

LIMITATIONS

Patients with prior fistula surgery (approximately 20%) led to heterogeneity. The total laser energy delivered varied depending on fistula anatomy.

CONCLUSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT06212739.

摘要

背景

先前的研究主要关注肛瘘治疗的手术结果，如愈合率，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

比较激光闭合术和括约肌间瘘管结扎术（LIFT）治疗肛瘘患者术后 6 小时和 24 小时的疼痛评分。

设计

前瞻性、双盲随机对照试验。

地点

马来西亚一家四级医院。

患者

年龄在 18-75 岁之间的高位经括约肌肛瘘患者。

干预措施

肛瘘激光闭合术与瘘管结扎术（LIFT）治疗。

主要观察指标

疼痛评分、控便能力、生活质量（QOL）、手术时间和治疗失败情况，采用卡方检验、Fisher 确切检验、学生 t 检验或 Mann-Whitney 检验，p 值<0.05 表示具有统计学意义。

结果

共招募了 56 名患者（激光组，n=28；LIFT 组，n=28）。激光组与 LIFT 组术后 6 小时的中位疼痛评分分别为 1.0 与 2.0（Rest，p=0.213）和 3.0 与 4.0（Movement，p=0.448）。24 小时后，两组在休息时均降至 2.5（p=0.842），但在运动时分别增加至 4.8 与 3.5（p=0.383）。激光组的手术时间明显短于 LIFT 组（32.5 分钟；p<0.001）。激光治疗组患者的工作恢复时间呈缩短趋势（10.5 天 vs. 14.0 天；p=0.181），但治疗失败率相似（54% vs. 50%；p=0.71）。没有患者发生术后失禁。SF-36 评分从基线（67.1±17.0；95%CI 63.6-82.4）增加到术后 6 个月（77.7±21.0；95%CI 57.0-80.3），无论手术类型如何（p>0.05）。