Determination of ileus incidence in patients with pelvic fracture and femur who received demthicone.
The incidence of ileus in patients in the control group
Comparison of ileus incidence in intervention and control groups.
Design
After obtaining written consent, the available samples will be randomly divided into two groups of intervention and control using random 4 percentiles.
Allocation: Random
Based on the lack of similar studies and lack of sufficient information to calculate the sample size, according to experts, the probability of ileus incidence in patients (control group) and in the permanent group was 25%. By taking a=%5
The sample size in each group was 55 samples.
Settings and conduct
The study is performed on patients with pelvic and femoral fractures in Madani Hospital.
The study will be performed by giving 40 mg dimethicone tablets 3 times a day to the intervention group and observation of the control group.
The duration of follow-up is from hospitalization to discharge.
Then, the effect of dimethicone on prevention of ileus and the frequency of ileus in the control group and Intervention is investigated.
Finally, the data obtained from the patients will be collected in a questionnaire and analyzed.
Participants/Inclusion and exclusion criteria
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.
Exclusion criteria: Patients will be excluded if they have symptoms of ileus or take prokinetic drugs before surgery.
Intervention groups
Intervention group: Patients with pelvic and femoral fractures who will be used to prevent ileus dimethicone.
Control group: Patients with pelvic and femoral fractures who will undergo routine treatment without receiving any specific medications.
Main outcome variables
Incidence of Ileus in Observation and Intervention Group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200708048064N1
Registration date:2020-11-23, 1399/09/03
Registration timing:prospective
Last update:2020-11-23, 1399/09/03
Update count:0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Shayan Shahsavary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3448 4802
Email address
shadesofshayan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-30, 1399/09/10
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Dimethicon On Prevention Of Ileus In Patients Suffering From Pelvic and Femoral Fractures A Randomized Clinical Trial
Public title
The Effect of Dimethicon On Prevention Of Ileus In Patients Suffering From Pelvic and Femoral Fractures A Randomized Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Exclusion criteria: Patients will be excluded if they have symptoms of ileus or take prokinetic drugs before surgery.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Alborz University of Medical Sciences
Street address
Research and Technology Committee - Saffari Ave , 45 meter Golshahr Street , Karaj
City
کرج
Province
Alborz
Postal code
3198764653
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.ABZUMS.REC.1399.188
Health conditions studied
1
Description of health condition studied
Ileus In Hip and femoral fracture Patients
ICD-10 code
K56.0
ICD-10 code description
Paralytic ileus
Primary outcomes
1
Description
Determining Incidence rate of Ileus in patients receiving dimethicone
Timepoint
From the onset of admission in ward
Method of measurement
Patient History - Clinical Examination
Secondary outcomes
1
Description
Comparison of gas passage time between intervention and control groups
Timepoint
From hospitalization until gas passage during hospitalization
Method of measurement
Patient history
Intervention groups
1
Description
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. )
Category
Prevention
2
Description
Control group:The Control Group will be Treated with Routine Care.