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NCT02604732 Clinical Trial

Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02604732
Other study ID # 2015/00512
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2016
Est. completion date May 31, 2024

Study information
Verified date April 2023
Source National University Hospital, Singapore
Contact Davide Lomanto, MD PhD
Phone +6567725903
Email surdl@nus.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 31, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic inguinal hernia repair with perioperative Aspirin
Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively
• Laparoscopic inguinal hernia repair without perioperative Aspirin
Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery

Locations
Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)
Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of hematoma Postoperative scrotal or groin hematoma (not including skin bruising) 24 hours
Secondary Incidence of seroma Postoperative scrotal or groin seroma 24 hours
Secondary Incidence of hematoma requiring intervention Including blood transfusion, percutaneous drainage or surgical hemostasis 30 days
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