Department of Surgery, Section of Colon and Rectal Surgery, University of Alexandria, Egypt.
Department of Surgery, Unit of Colon and Rectal Surgery, University of Mansoura, Egypt.
Surgery. 2021 Jul;170(1):61-66. doi: 10.1016/j.surg.2020.12.025. Epub 2021 Jan 31.
Success rate after ligation of the inter-sphincteric fistula tract ranges from 40% to 75%. Platelet-rich plasma is hypothesized to improve healing by slowly releasing growth factors. The objective of the study was to compare the efficacy and outcome of ligation of the inter-sphincteric fistula tract plus platelet-rich plasma local injection versus ligation of the inter-sphincteric fistula tract alone in the management of high trans-sphincteric anal fistula in regards to postoperative pain, time for healing, morbidity, fistula closure rate, recurrence, and quality of life.
This was a prospective randomized trial. Patients with trans-sphincteric anal fistulas involving >50% of anal sphincters were included. Patients were randomly assigned to either ligation of the inter-sphincteric fistula tract plus platelet-rich plasma or ligation of the inter-sphincteric fistula tract (49 in each group). The primary endpoints were successful complete fistula closure and duration needed for healing. Secondary endpoints were morbidity, recurrence after 1 year of follow-up, postoperative pain, and quality of life.
Complete primary healing was recorded in 42 patients in the ligation of the inter-sphincteric fistula tract plus platelet-rich plasma group and 32 patients in the ligation of the inter-sphincteric fistula tract group, and the difference was statistically significant (P = .03). The mean time to complete healing after ligation of the inter-sphincteric fistula tract plus platelet-rich plasma was significantly shorter than after ligation of the inter-sphincteric fistula tract alone (15.7 ± 4 days vs 21.6 ± 5.4 days; P = .03). One year after complete healing of anal fistula, recurrence was recorded in 4/42 patients in the ligation of the inter-sphincteric fistula tract plus platelet-rich plasma group and 3/32 patients in the ligation of the inter-sphincteric fistula tract group with no statistically significant difference (P = .99). Patients in the ligation of the inter-sphincteric fistula tract plus platelet-rich plasma group had significantly lower pain scores after both 1 and 7 days. Quality of life and level of happiness were significantly better 1 month after ligation of the inter-sphincteric fistula tract plus platelet-rich plasma.
Ligation of the inter-sphincteric fistula tract plus platelet-rich plasma for the treatment of high trans-sphincteric fistula-in-ano is a safe modality with significantly higher successful healing rate, shorter healing time, and less postoperative pain compared with ligation of the inter-sphincteric fistula tract alone. Ligation of the inter-sphincteric fistula tract plus platelet-rich plasma does not improve the rate of recurrence; however, it results in significantly higher short-term quality of life.
括约肌间瘘管结扎术的成功率为 40%至 75%。富含血小板的血浆通过缓慢释放生长因子被假设为可改善愈合。本研究的目的是比较括约肌间瘘管结扎加富含血小板的血浆局部注射与单独括约肌间瘘管结扎治疗高位经括约肌型肛瘘的疗效和结果，具体为术后疼痛、愈合时间、发病率、瘘管闭合率、复发率和生活质量。
这是一项前瞻性随机试验。纳入涉及>50%肛门括约肌的高位经括约肌型肛瘘患者。患者被随机分配至括约肌间瘘管结扎加富含血小板的血浆组或括约肌间瘘管结扎组（每组 49 例）。主要终点为完全瘘管闭合和愈合所需时间。次要终点为发病率、1 年后随访复发率、术后疼痛和生活质量。
括约肌间瘘管结扎加富含血小板的血浆组 42 例患者和括约肌间瘘管结扎组 32 例患者完全治愈，差异有统计学意义（P=0.03）。括约肌间瘘管结扎加富含血小板的血浆组的平均愈合时间明显短于单独括约肌间瘘管结扎组（15.7±4 天比 21.6±5.4 天；P=0.03）。高位经括约肌型肛瘘完全愈合 1 年后，括约肌间瘘管结扎加富含血小板的血浆组有 4/42 例患者复发，而括约肌间瘘管结扎组有 3/32 例患者复发，差异无统计学意义（P=0.99）。括约肌间瘘管结扎加富含血小板的血浆组患者在术后第 1 天和第 7 天的疼痛评分明显较低。括约肌间瘘管结扎加富含血小板的血浆组患者在术后 1 个月的生活质量和幸福感明显更高。
与单独括约肌间瘘管结扎相比，括约肌间瘘管结扎加富含血小板的血浆治疗高位经括约肌型肛瘘是一种安全的方法，其愈合成功率显著更高，愈合时间更短，术后疼痛更少。括约肌间瘘管结扎加富含血小板的血浆并不能提高复发率，但会显著提高短期生活质量。
