Khaled M Madbouly1, Sameh Hany Emile2, Yasmine Amr Issa3, Waleed Omar2. 1. Department of Surgery, Section of Colon and Rectal Surgery, University of Alexandria, Egypt. Electronic address: khaled.madbouly@alexmed.edu.eg. 2. Department of Surgery, Unit of Colon and Rectal Surgery, University of Mansoura, Egypt. 3. Department of Medical Biochemistry, University of Alexandria, Egypt.
Abstract
BACKGROUND: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. METHODS: 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. RESULTS: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. CONCLUSION: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.
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.