Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

National University Health System (NUHS)

Status: Enrolling

Conditions: Inguinal Hernia

Treatments: Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin; Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02604732

2015/00512

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Patients who stop Aspirin perioperatively

Active Comparator group

Description:

Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery

Treatment:

Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin

Patients who continue Aspirin perioperatively

Experimental group

Description:

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Treatment:

Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin