Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery.

Detailed Description
-----------------
This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery. Simple randomization will be performed and allocation is via closed envelope method. The surgeon will be blinded regarding the usage of Aspirin. The primary outcome is the incidence of post-operative hematoma formation within the first 24 hours after surgery. The secondary outcomes are the incidence of post-operative seroma formation within 24 hours, the incidence of post-operative hematoma requiring intervention (including blood transfusion, percutaneous drainage and surgical hemostasis) within 30 days, pain at regular intervals and the incidence of other post-operative complications.

Official Title
-----------------
Randomized Controlled Trial on Pre-operative Withdrawal Versus no Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin
* Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair Age 21-80 years Patients taking Aspirin BMI 18-30 Exclusion Criteria: Age <21 and >80years Recurrent inguinal hernia Coagulopathy Patients who can't stop Aspirin BMI <18 and >30

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients who stop Aspirin perioperatively<br>Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery | Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin<br>* Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery<br>|
| Experimental: Patients who continue Aspirin perioperatively<br>Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively | Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin<br>* Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hematoma | Postoperative scrotal or groin hematoma (not including skin bruising) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of seroma | Postoperative scrotal or groin seroma | 24 hours | 
| Incidence of hematoma requiring intervention | Including blood transfusion, percutaneous drainage or surgical hemostasis | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Inguinal Hernia, Laparoscopic Inguinal Hernia Repair