Inguinal HerniaNCT02604732
Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
A study testing Laparoscopic inguinal hernia repair with perioperative Aspirin and Laparoscopic inguinal hernia repair without perioperative Aspirin in people with Inguinal Hernia, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Laparoscopic inguinal hernia repair with perioperative Aspirin and Laparoscopic inguinal hernia repair without perioperative Aspirin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2016to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair
- Age 21-80 years
- Patients taking Aspirin
- BMI 18-30
Who cannot join
- Age <21 and >80years
- Recurrent inguinal hernia
- Coagulopathy
- Patients who can't stop Aspirin
- BMI <18 and >30
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Davide Lomanto, MD PhD, +6567725903, surdl@nus.edu.sg
Davide Lomanto, MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Laparoscopic inguinal hernia repair with perioperative Aspirin, Laparoscopic inguinal hernia repair without perioperative Aspirin
- Keywords
- Inguinal Hernia, Laparoscopic Inguinal Hernia Repair, Aspirin
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic inguinal hernia repair with perioperative AspirinProcedure or surgery
Patients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively
Laparoscopic inguinal hernia repair without perioperative AspirinProcedure or surgery
Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients who stop Aspirin perioperatively | Active comparator | Patients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery Receives: 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 Receives: Procedure: Laparoscopic inguinal hernia repair with perioperative Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hematoma
Postoperative scrotal or groin hematoma (not including skin bruising)
Measured: 24 hours
Secondary outcomes (2)
Incidence of seroma
Postoperative scrotal or groin seroma
Measured: 24 hours
Incidence of hematoma requiring intervention
Including blood transfusion, percutaneous drainage or surgical hemostasis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start1 Apr 2016
- Primary completion29 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide Lomanto, MD PhD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604732
- Sponsor's protocol ID
- 2015/00512
- Other IDs
- 2015
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2015
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40616699
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Pre-operative Withdrawal Versus no Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02604732
- Acronym / sponsor ID
- 2015/00512
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal Hernia, Laparoscopic Inguinal Hernia Repair, Aspirin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who stop Aspirin perioperatively | Active comparator | Procedure: Laparoscopic inguinal hernia repair without perioperative AspirinPatients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery |
| Patients who continue Aspirin perioperatively | Experimental | Procedure: Laparoscopic inguinal hernia repair with perioperative AspirinPatients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair
- Age 21-80 years
- Patients taking Aspirin
- BMI 18-30
Key exclusion criteria (5 listed)
- Age <21 and >80years
- Recurrent inguinal hernia
- Coagulopathy
- Patients who can't stop Aspirin
- BMI <18 and >30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic inguinal hernia repair with perioperative AspirinPatients undergoing laparoscopic inguinal hernia repair will continue on Aspirin perioperatively | Procedure or surgery | Patients who continue Aspirin perioperatively |
| Laparoscopic inguinal hernia repair without perioperative AspirinPatients undergoing laparoscopic inguinal hernia repair will stop Aspirin 5-7 days before the surgery | Procedure or surgery | Patients who stop Aspirin perioperatively |
Primary outcome
Incidence of hematoma
Time frame: 24 hours
Postoperative scrotal or groin hematoma (not including skin bruising)
2 secondary outcomes
Incidence of seroma
Time frame: 24 hours
Incidence of hematoma requiring intervention
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 40616699Tan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Lomanto, MD PhD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic inguinal hernia repair with perioperative Aspirin and Laparoscopic inguinal hernia repair without perioperative Aspirin in people with Inguinal Hernia, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Lomanto, MD PhD (+6567725903, surdl@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hematoma (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.