Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

Not Applicable

Recruiting

• Conditions: Inguinal Hernia
• Interventions: Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin; Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin

• Registration Number: NCT02604732
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-13
• Study Start: 2016-04-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-02-29
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who stop Aspirin perioperatively	Laparoscopic inguinal hernia repair without perioperative Aspirin	Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery
Patients who continue Aspirin perioperatively	Laparoscopic inguinal hernia repair with perioperative Aspirin	Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Primary Outcome Measures

Name	Time	Method
Incidence of hematoma	24 hours	Postoperative scrotal or groin hematoma (not including skin bruising)

Secondary Outcome Measures

Name	Time	Method
Incidence of hematoma requiring intervention	30 days	Including blood transfusion, percutaneous drainage or surgical hemostasis
Incidence of seroma	24 hours	Postoperative scrotal or groin seroma

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore