Jolynn Qian Lin Low, Retnagowri Rajandram, Mohamed Rezal Abdul Aziz, April Camilla Roslani
{"title":"激光瘘管闭合术后疼痛与括约肌间瘘管结扎术后疼痛:一项前瞻性双盲随机对照试验。","authors":"Jolynn Qian Lin Low, Retnagowri Rajandram, Mohamed Rezal Abdul Aziz, April Camilla Roslani","doi":"10.1002/wjs.12242","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To compare pain scores at 6 and 24 h postoperatively between laser closure and ligation of the intersphincteric tract for anal fistula.</p><p><strong>Design: </strong>Prospective, double-blinded randomized controlled trial.</p><p><strong>Settings: </strong>A quaternary hospital in Malaysia.</p><p><strong>Patients: </strong>Patients aged 18-75 years with high transsphincteric fistulas.</p><p><strong>Intervention: </strong>Fistula laser closure versus ligation of the fistula tract (LIFT) treatment.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Limitations: </strong>Patients with prior fistula surgery (approximately 20%) led to heterogeneity. The total laser energy delivered varied depending on fistula anatomy.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT06212739.</p>","PeriodicalId":23926,"journal":{"name":"World Journal of Surgery","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Postoperative pain following laser fistula closure versus ligation of the intersphincteric fistula tract: A prospective double-blinded randomized controlled trial.\",\"authors\":\"Jolynn Qian Lin Low, Retnagowri Rajandram, Mohamed Rezal Abdul Aziz, April Camilla Roslani\",\"doi\":\"10.1002/wjs.12242\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To compare pain scores at 6 and 24 h postoperatively between laser closure and ligation of the intersphincteric tract for anal fistula.</p><p><strong>Design: </strong>Prospective, double-blinded randomized controlled trial.</p><p><strong>Settings: </strong>A quaternary hospital in Malaysia.</p><p><strong>Patients: </strong>Patients aged 18-75 years with high transsphincteric fistulas.</p><p><strong>Intervention: </strong>Fistula laser closure versus ligation of the fistula tract (LIFT) treatment.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Limitations: </strong>Patients with prior fistula surgery (approximately 20%) led to heterogeneity. The total laser energy delivered varied depending on fistula anatomy.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT06212739.</p>\",\"PeriodicalId\":23926,\"journal\":{\"name\":\"World Journal of Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"World Journal of Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/wjs.12242\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/6/6 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"World Journal of Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/wjs.12242","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/6 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
Postoperative pain following laser fistula closure versus ligation of the intersphincteric fistula tract: A prospective double-blinded randomized controlled trial.
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.
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.
期刊介绍:
World Journal of Surgery is the official publication of the International Society of Surgery/Societe Internationale de Chirurgie (iss-sic.com). Under the editorship of Dr. Julie Ann Sosa, World Journal of Surgery provides an in-depth, international forum for the most authoritative information on major clinical problems in the fields of clinical and experimental surgery, surgical education, and socioeconomic aspects of surgical care. Contributions are reviewed and selected by a group of distinguished surgeons from across the world who make up the Editorial Board.