Sameh Hany Emile1, Mohamed Anwar Abdel-Razik2, Ayman Elshobaky3, Samy Abbas Elbaz4, Wael Khafagy5, Mostafa Shalaby6. 1. Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: sameh200@hotmail.com. 2. Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: drmohamedanwar1981@yahoo.com. 3. Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: elshobakyayman@yahoo.com. 4. Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: sami_mrcsed@yahoo.com. 5. Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: wkhafagy@yahoo.com. 6. Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: mostafashalaby@mans.edu.eg.
Abstract
BACKGROUND:Chronic anal fissure (CAF) is a common painful anal condition. Medical treatment of CAF involves the use of agents that induce chemical sphincterotomy. The present trial aimed to compare the efficacy and safety of topical minoxidil and glyceryl trinitrate (GTN) preparations in treatment of CAF. METHODS:Adult patients with CAF were randomly assigned to one of two equal groups; group I received topical 5% minoxidil gel and group II received topical 0.2% GTN cream. The main outcome measures were healing of anal fissure, duration to healing, relief of symptoms, and adverse effects. RESULTS:62 patients (36 female and 26 male) were included to the study. Group I comprised 30 patients and group II comprised 32 patients. Healing of anal fissure was achieved in 23 (76.7%) patients in group I and 15 (46.9%) patients in group II (p = 0.03). The average duration to healing in group I was significantly shorter than group II (4.1 ± 1.9 vs 5.3 ± 2.7 weeks, p = 0.048). Adverse effects were recorded in 2 (6.6%) patients in group I and 13 (40.6%) patients in group II. The post-treatment pain score in the GTN group was significantly lower than the Minoxidil group. CONCLUSION: Topical 5% minoxidil gel achieved greater and quicker healing of CAF and fewer adverse effects than topical 0.2% GTN cream. Post-treatment pain scores after GTN were significantly lower than minoxidil. TRIAL REGISTRATION NUMBER: NCT03528772.
RCT Entities:
BACKGROUND: Chronic anal fissure (CAF) is a common painful anal condition. Medical treatment of CAF involves the use of agents that induce chemical sphincterotomy. The present trial aimed to compare the efficacy and safety of topical minoxidil and glyceryl trinitrate (GTN) preparations in treatment of CAF. METHODS: Adult patients with CAF were randomly assigned to one of two equal groups; group I received topical 5% minoxidil gel and group II received topical 0.2% GTN cream. The main outcome measures were healing of anal fissure, duration to healing, relief of symptoms, and adverse effects. RESULTS: 62 patients (36 female and 26 male) were included to the study. Group I comprised 30 patients and group II comprised 32 patients. Healing of anal fissure was achieved in 23 (76.7%) patients in group I and 15 (46.9%) patients in group II (p = 0.03). The average duration to healing in group I was significantly shorter than group II (4.1 ± 1.9 vs 5.3 ± 2.7 weeks, p = 0.048). Adverse effects were recorded in 2 (6.6%) patients in group I and 13 (40.6%) patients in group II. The post-treatment pain score in the GTN group was significantly lower than the Minoxidil group. CONCLUSION: Topical 5% minoxidil gel achieved greater and quicker healing of CAF and fewer adverse effects than topical 0.2% GTN cream. Post-treatment pain scores after GTN were significantly lower than minoxidil. TRIAL REGISTRATION NUMBER: NCT03528772.