The effect of discontinuation of aspirin on complication of inguinal hernia surgery in patient receiving aspirin
Design
Clinical trial with randomized control group. Patients referred to specialized clinics after referral for surgery were randomly divided into two groups.
Settings and conduct
In this study, patients were randomly divided into two groups of 50, based on their inclusion criteria. The first group without aspirin and the second group with aspirin at the Babol University of Medical Sciences affiliated hospitals are going under the hernia repair surgery. The amount of pain is assessed based on the visual scale (VAS) postoperation as well as on possible complications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inguinal hernia, age over 18 years old, Daily aspirin therapy Exclusion criteria: Patients with unstable angina, Congestive Heart Failure, Shock, Aspirin sensitivity, History of gastrointestinal and cerebral hemorrhage, Patients treated with Warfarin, plavix and methotrexate
Intervention groups
Intervention group: For patients in the first group, aspirin (Jalinous, Iran) is discontinued 7 days before surgery.
Control group: 80 mg Aspirin, single dose is prescribed before surgery and will continue.
The effect of discontinuation of aspirin on complications of inguinal hernia surgery in patients receiving aspirin
Public title
The effect of discontinuation of aspirin on complication of inguinal hernia surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inguinal hernia
Age over 18 years old
Daily aspirin therapy
Exclusion criteria:
Patients with unstable angina
Congestive Heart Failure
Shock
Aspirin sensitivity
History of gastrointestinal and cerebral hemorrhage
Patients treated with warfarin, plavix and methotrexate
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two groups by a simple random method.
In this research, the coin toss will be used to create a random sequence in a two-group trial.
So that one of the study groups is tail and the other group is considered as a head, and according to the sample size, the same amount of coin is tossed and the subjects are divided into two groups of random allocation.
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 committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.051
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Bleeding
Timepoint
During the operation, Immediately after surgery
Method of measurement
Number of consumed gases
2
Description
Postoperative hematoma
Timepoint
12 and 24 hours after surgery
Method of measurement
Clinical examination
3
Description
Postoperative complications
Timepoint
7 days after surgery
Method of measurement
Clinical examination
4
Description
Postoperative pain
Timepoint
4, 8, 12 hours after surgery
Method of measurement
Visual Analog Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aspirin 80 mg will be discontinued (Jalinous, Iran) 7 days before surgery.
Category
Prevention
2
Description
Control group: 80 mg Aspirin (Jalinous, Iran) single dose is prescribed before surgery and will continue.