Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

NCT ID: NCT02604732

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Patients who stop Aspirin perioperatively

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

Group Type ACTIVE_COMPARATOR

Laparoscopic inguinal hernia repair without perioperative Aspirin

Intervention Type PROCEDURE

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

Patients who continue Aspirin perioperatively

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Group Type EXPERIMENTAL

Laparoscopic inguinal hernia repair with perioperative Aspirin

Intervention Type PROCEDURE

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Interventions

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Laparoscopic inguinal hernia repair with perioperative Aspirin

Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively

Intervention Type PROCEDURE

Laparoscopic inguinal hernia repair without perioperative Aspirin

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davide Lomanto, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Davide Lomanto, MD PhD

Role: CONTACT

+6567725903

Facility Contacts

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Davide Lomanto, MD PhD

Role: primary

+6567725903

References

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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.

Reference Type DERIVED
PMID: 40616699 (View on PubMed)

Other Identifiers

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2015/00512

Identifier Type: -

Identifier Source: org_study_id

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