Abdulwahid M Salih1, Fahmi H Kakamad2, Rawezh Q Salih3, Shvan H Mohammed3, Imad J Habibullah3, Zuhair D Hammood3, Masrur S Aziz3, Hiwa O Baba3. 1. Faculty of Medical Sciences, School of Medicine, Department Surgery, University of Sulaimani, Sulaimani, Kurdistan, Iraq. 2. Faculty of Medical Sciences, School of Medicine, Department Cardiothoracic and Vascular Surgery, University of Sulaimani, Sulaimani, Kurdistan, Iraq; Kscien Organization for Scientific Research, Sulaimani, Kurdistan, Iraq. Electronic address: fahmi.hussein@univsul.edu.iq. 3. Kscien Organization for Scientific Research, Sulaimani, Kurdistan, Iraq.
Abstract
BACKGROUND:Pilonidal sinus disease is a common perianal inflammatory condition. Currently, operative therapy is the standard management strategy. The aim of this study is to investigate the efficacy of a preparation with antimicrobial, sclerosing, and wound-enhancing properties in the nonoperative management of pilonidal sinus disease. METHODS: A parallel randomized controlled trial was conducted between January 2013 and January 2017 to investigate the effect of a mixture of sclerosing agent and herbal product (Lawsonia inermis powder) in the management of sacrococcygeal pilonidal sinus disease. The patients were allocated randomly into the study group (group receiving injection of the mixture into the sinus track) and the control group (group receiving the classic technique of operative excision and primary closure). RESULTS: This study was conducted among 400 patients, 316 (79%) male, 84 (21%) female. The age range was 18 to 40 years with a mean age of 27.1 years (standard deviation, ±2.4); each group included 200 patients. None of the patients had an abscess or complicated pilonidal disease. Cure rate, defined as complete healing of the sinus, was high among both groups after the first intervention (94% for control group and 89% for the test group, respectively; P = .051). In the study group, there was a statistically significant decrease in hospital stay, cost, perioperative pain, duration of absence from work, and duration of the procedure. CONCLUSION: According to this trial, the injection of this mixture appears to be better than the other therapeutic options for pilonidal sinus disease in terms of cost effectiveness, time off work, rate of complication, and perioperative pain.
RCT Entities:
BACKGROUND:Pilonidal sinus disease is a common perianal inflammatory condition. Currently, operative therapy is the standard management strategy. The aim of this study is to investigate the efficacy of a preparation with antimicrobial, sclerosing, and wound-enhancing properties in the nonoperative management of pilonidal sinus disease. METHODS: A parallel randomized controlled trial was conducted between January 2013 and January 2017 to investigate the effect of a mixture of sclerosing agent and herbal product (Lawsonia inermis powder) in the management of sacrococcygeal pilonidal sinus disease. The patients were allocated randomly into the study group (group receiving injection of the mixture into the sinus track) and the control group (group receiving the classic technique of operative excision and primary closure). RESULTS: This study was conducted among 400 patients, 316 (79%) male, 84 (21%) female. The age range was 18 to 40 years with a mean age of 27.1 years (standard deviation, ±2.4); each group included 200 patients. None of the patients had an abscess or complicated pilonidal disease. Cure rate, defined as complete healing of the sinus, was high among both groups after the first intervention (94% for control group and 89% for the test group, respectively; P = .051). In the study group, there was a statistically significant decrease in hospital stay, cost, perioperative pain, duration of absence from work, and duration of the procedure. CONCLUSION: According to this trial, the injection of this mixture appears to be better than the other therapeutic options for pilonidal sinus disease in terms of cost effectiveness, time off work, rate of complication, and perioperative pain.
Authors: Abdulwahid M Salih; Fahmi H Kakamad; Zuhair D Hammood; Hiwa O Baba; Imad J Habibullah; Rawezh Q Salih; Shvan H Mohammed Journal: Int J Surg Case Rep Date: 2019-12-09