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IRCT20200708048064N1 IRCT 2020-11-23 Karaj University of Medical Sciences The Effect of Dimethicon On Prevention Of Ileus In Patients Suffering From Pelvic and Femoral Fractures A Randomized Clinical Trial The Effect of Dimethicon On Prevention Of Ileus In Patients Suffering From Pelvic and Femoral Fractures A Randomized Clinical Trial 2020-11-30 anticipated 110 Complete https://irct.ir/trial/50357 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block Randomization will be used. Each block will contain 4 individuals. The sequence of patients in each block is random. The number of subjects is equal and two are from the intervention group and two are from the control group. Stratification of Randomization will not be used. 3 Ileus In Hip and femoral fracture Patients. Intervention 1: Intervention group: Dimethicone 40 mg Pills will be given to the Intervention group three times a day and it will be consumed from the point of admission in hospital. So far, no study has been conducted to investigate the effect of dimethicone to prevent ileus following pelvic and femoral fractures. The closest study was to investigate the effect of simethicone on ileus after colorectal surgery.(1) In some cases, acupuncture and simo decoction, alvimopan and chewing gum, in studies have been useful in the treatment of ileus.(2 , 3 , 4) Despite several studies on the factors affecting the incidence of ileus and the study of different treatments, a suitable preventive method has not yet been suggested to prevent this complication, which indicates the necessity of further and wider studies in this case, so due to the high prevalence of ileus in patients of Madani hospital, it was decided to investigate a method to prevent this disease. References: (1Jeremy E.Springer ShirazElkheir CaglaEskicioglu Aristithes G.Doumouras StephenKelly IlunYangaShawnForbes. The effect of simethicone on postoperative ileus in patients undergoing colorectal surgery(SPOT), a randomized controlled trial. International Journal of Surgery Volume 56, August 2018, Pages141-147) (2 Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, et al. Alvimopan, a Novel, Peripherally .1Acting μ Opioid Antagonist: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, PhaseIII Trial of Major Abdominal Surgery and Postoperative Ileus. Annals of surgery. 2004;240(4):728-35.) (3 Yang Y, Zuo HQ, Li Z, Qin YZ, Mo XW, Huang MW, et al. Comparison of efficacy of simo decoction and acupuncture or chewing gum alone on postoperative ileus in colorectal cancer resection: a randomized trial.Scientific reports. 2017;7:37826. ) (4 van den Heijkant TC, Costes LM, van der Lee DG, Aerts B, Osinga-de Jong M, Rutten HR, et al.Randomized clinical trial of the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery. The British journal of surgery. 2015;102(3):202-11. ). Intervention 2: Control group:The Control Group will be Treated with Routine Care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Haleh paak
Shahid madani Square, Jahanshar , Karaj
Karaj Iran (Islamic Republic of) 3155718631 +98 26 3250 8967 halehpak80.md@gmail.com Karaj University of Medical Sciences scientific Haleh paak
Shahid madani Square, Jahanshar , Karaj
Karaj Iran (Islamic Republic of) 3155718631 +98 26 3250 8967 halehpak80.md@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: All patients with different types of pelvic and femoral fractures who were admitted to Madani Hospital for at least 3 days and treated during the study. no limit no limit Both Exclusion criteria: Patients will be excluded if they have symptoms of ileus or take prokinetic drugs before surgery. K56.0 Paralytic ileus Prevention N/A Intervention group: Dimethicone 40 mg Pills will be given to the Intervention group three times a day and it will be consumed from the point of admission in hospital. So far, no study has been conducted to investigate the effect of dimethicone to prevent ileus following pelvic and femoral fractures. The closest study was to investigate the effect of simethicone on ileus after colorectal surgery.(1) In some cases, acupuncture and simo decoction, alvimopan and chewing gum, in studies have been useful in the treatment of ileus.(2 , 3 , 4) Despite several studies on the factors affecting the incidence of ileus and the study of different treatments, a suitable preventive method has not yet been suggested to prevent this complication, which indicates the necessity of further and wider studies in this case, so due to the high prevalence of ileus in patients of Madani hospital, it was decided to investigate a method to prevent this disease. References: (1Jeremy E.Springer ShirazElkheir CaglaEskicioglu Aristithes G.Doumouras StephenKelly IlunYangaShawnForbes. The effect of simethicone on postoperative ileus in patients undergoing colorectal surgery(SPOT), a randomized controlled trial. International Journal of Surgery Volume 56, August 2018, Pages141-147) (2 Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, et al. Alvimopan, a Novel, Peripherally .1Acting μ Opioid Antagonist: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled, PhaseIII Trial of Major Abdominal Surgery and Postoperative Ileus. Annals of surgery. 2004;240(4):728-35.) (3 Yang Y, Zuo HQ, Li Z, Qin YZ, Mo XW, Huang MW, et al. Comparison of efficacy of simo decoction and acupuncture or chewing gum alone on postoperative ileus in colorectal cancer resection: a randomized trial.Scientific reports. 2017;7:37826. ) (4 van den Heijkant TC, Costes LM, van der Lee DG, Aerts B, Osinga-de Jong M, Rutten HR, et al.Randomized clinical trial of the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery. The British journal of surgery. 2015;102(3):202-11. ) Control group:The Control Group will be Treated with Routine Care. Determining Incidence rate of Ileus in patients receiving dimethicone. Timepoint: From the onset of admission in ward. Method of measurement: Patient History - Clinical Examination. Comparison of gas passage time between intervention and control groups. Timepoint: From hospitalization until gas passage during hospitalization. Method of measurement: Patient history. Karaj University of Medical Sciences Approved 2020-10-10 Ethics comittee of Alborz University of Medical Sciences Research and Technology Committee - Saffari Ave , 45 meter Golshahr Street , Karaj کرج Alborz Iran (Islamic Republic of)