NCT02604732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

7.9 years

First QC Date

November 10, 2015

Last Update Submit

April 16, 2023

Conditions

Inguinal Hernia

Keywords

Inguinal HerniaLaparoscopic Inguinal Hernia RepairAspirin

Outcome Measures

Primary Outcomes (1)

  • Incidence of hematoma

    Postoperative scrotal or groin hematoma (not including skin bruising)

    24 hours

Secondary Outcomes (2)

  • Incidence of seroma

    24 hours

  • Incidence of hematoma requiring intervention

    30 days

Study Arms (2)

Patients who stop Aspirin perioperatively

ACTIVE COMPARATOR

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

Procedure: Laparoscopic inguinal hernia repair without perioperative Aspirin

Patients who continue Aspirin perioperatively

EXPERIMENTAL

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin

Interventions

Laparoscopic inguinal hernia repair with perioperative AspirinPROCEDURE

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Patients who continue Aspirin perioperatively
Laparoscopic inguinal hernia repair without perioperative AspirinPROCEDURE

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

Patients who stop Aspirin perioperatively

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair
  • Age 21-80 years
  • Patients taking Aspirin
  • BMI 18-30

You may not qualify if:

  • Age \<21 and \>80years
  • Recurrent inguinal hernia
  • Coagulopathy
  • Patients who can't stop Aspirin
  • BMI \<18 and \>30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (1)

  • Tan L, Yeow M, Fatt SLK, Parameswaran R, Mahipal M, Loo L, Wijerathne S, Lomanto D. Cessation vs no cessation of acetylsalicylic acid preoperatively in laparoscopic totally extraperitoneal inguinal hernia repair (CAPTAIN): final report from a multi-center, single-blinded, randomized-controlled trial. Hernia. 2025 Jul 5;29(1):221. doi: 10.1007/s10029-025-03418-4.

    PMID: 40616699DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Davide Lomanto, MD PhD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Lomanto, MD PhD

CONTACT

+6567725903surdl@nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 13, 2015

Study Start

April 1, 2016

Primary Completion

February 29, 2024

Study Completion

May 31, 2024

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations

SG(1)