Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin; Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davide Lomanto, MD PhD; Phone Number: +6567725903; Email: surdl@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Davide Lomanto, MD PhD; Phone Number: +6567725903; Email: surdl@nus.edu.sg
    • Principal Investigator: Davide Lomanto, MD PhD
    • Sub-Investigator: Sujith Wijerathne, FRCS
    • Sub-Investigator: Sean Lee, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Investigators: Principal Investigator: Davide Lomanto, MD PhD, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): February 29, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Aspirin; Laparoscopic Inguinal Hernia Repair; Inguinal Hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 2015/00512