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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02604732
Enrollment
100
Registered
2015-11-13
Start date
2016-04-01
Completion date
2024-05-31
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Inguinal Hernia, Laparoscopic Inguinal Hernia Repair, Aspirin

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.

Interventions

PROCEDURELaparoscopic inguinal hernia repair with perioperative Aspirin

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

PROCEDURELaparoscopic inguinal hernia repair without perioperative Aspirin

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

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hematoma24 hoursPostoperative scrotal or groin hematoma (not including skin bruising)

Secondary

MeasureTime frameDescription
Incidence of seroma24 hoursPostoperative scrotal or groin seroma
Incidence of hematoma requiring intervention30 daysIncluding blood transfusion, percutaneous drainage or surgical hemostasis

Countries

Singapore

Contacts

Primary ContactDavide Lomanto, MD PhD
surdl@nus.edu.sg+6567725903

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026