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Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Laparoscopic inguinal hernia repair with perioperative Aspirin
Laparoscopic inguinal hernia repair without perioperative Aspirin
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inguinal Hernia focused on measuring Inguinal Hernia, Laparoscopic Inguinal Hernia Repair, Aspirin

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patients who stop Aspirin perioperatively

Patients who continue Aspirin perioperatively

Arm Description

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

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Outcomes

Primary Outcome Measures

Incidence of hematoma
Postoperative scrotal or groin hematoma (not including skin bruising)

Secondary Outcome Measures

Incidence of seroma
Postoperative scrotal or groin seroma
Incidence of hematoma requiring intervention
Including blood transfusion, percutaneous drainage or surgical hemostasis

Full Information

First Posted
November 10, 2015
Last Updated
April 16, 2023
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02604732
Brief Title
Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
Official Title
Randomized Controlled Trial on Pre-operative Withdrawal Versus no Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal Hernia, Laparoscopic Inguinal Hernia Repair, Aspirin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients who stop Aspirin perioperatively
Arm Type
Active Comparator
Arm Description
Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery
Arm Title
Patients who continue Aspirin perioperatively
Arm Type
Experimental
Arm Description
Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic inguinal hernia repair with perioperative Aspirin
Intervention Description
Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic inguinal hernia repair without perioperative Aspirin
Intervention Description
Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery
Primary Outcome Measure Information:
Title
Incidence of hematoma
Description
Postoperative scrotal or groin hematoma (not including skin bruising)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Incidence of seroma
Description
Postoperative scrotal or groin seroma
Time Frame
24 hours
Title
Incidence of hematoma requiring intervention
Description
Including blood transfusion, percutaneous drainage or surgical hemostasis
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Lomanto, MD PhD
Phone
+6567725903
Email
surdl@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide Lomanto, MD PhD
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Lomanto, MD PhD
Phone
+6567725903
Email
surdl@nus.edu.sg
First Name & Middle Initial & Last Name & Degree
Davide Lomanto, MD PhD
First Name & Middle Initial & Last Name & Degree
Sujith Wijerathne, FRCS
First Name & Middle Initial & Last Name & Degree
Sean Lee, FRCS

12. IPD Sharing Statement

Learn more about this trial

Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

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