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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

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