Umbilical Hernia RepairNCT07845370
Topical Tranexamic Acid Spray Versus No Spray on Postoperative Outcomes Following Mesh Repair of Umbilical Hernia
A study testing Topical Tranexamic Acid Spray and No Topical Tranexamic acid in people with Umbilical Hernia Repair, run by Dr Mudassar Saeed Pansota at 1 site in Pakistan.
Trial summary
Umbilical hernia is a type of ventral hernia that occurs commonly in adulthood, and mesh reinforcement is well established since there is a reduced recurrence rate when compared to suture repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Umbilical Hernia Repair
- What is being tested?
- Topical Tranexamic Acid Spray and No Topical Tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2026to 14 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years.
- Either gender.
- Patient has primary umbilical hernia.
- To have elective umbilical hernia open meshes repair planned.
- Hernia defect that can be repaired with the help of the standardized mesh technique that was used in the study.
- ASA physical status I-III.
- No acute infection in or about the site of operations.
- Able to provide written informed consent
Who cannot join
- • Emergency with incarcerated, obstructed, or strangulated umbilical hernia.
- Frequent umbilical or ventral hernia.
- Major abdominal surgery scheduled concomitants on the same surgery.
- Active local or systemic infection.
- Hypersensitivity known to tranexamic acid.
- History or current deep-vein thrombosis or pulmonary embolism or other thromboembolic hemorrhagic disease.
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- Known inherited/acquired thrombophilia.
- Greater renal impairment that needed to be avoided or have its dosage increased significantly with tranexamic acid.
- History of seizures/ epilepsy where tranexamic acid is inappropriate.
- The presence of currently used therapeutic anticoagulation which may not be controlled accordingly during operation.
- Coagulopathy or known bleeding.
- Pregnancy or breastfeeding.
- Patients who need a significantly different operative or mesh method intraoperative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mudassar pansota, MS urology contact
Pakistan1 site
Pakistan Railway Hospital, Rawalpindi
Rawalpindi, Punjab Province, 60000
Saleh Tariq Dr Saleh Tariq Kazi, MBBS, netygeulis749@hotmail.com
mudassar pansota, MS urology, netygeulis749@hotmail.com
About this study
Official title: Effect of Topical Tranexamic Acid Spray Versus No Spray on Postoperative Seroma and Wound-Related Outcomes Following Mesh Repair of Umbilical Hernia: A Randomized Controlled Trial
Umbilical hernia is a type of ventral hernia that occurs commonly in adulthood, and mesh reinforcement is well established since there is a reduced recurrence rate when compared to suture repair. However, the repair of meshes could prove to be complex due to seroma, hematoma, wound infection, pain, and other surgical-site events.3 Seroma formation is considered clinically significant due to its ability to be painful, recurrent outpatient care, aspiration, infection, and slow wound healing.
Read the detailed description
Surgical techniques that minimize bleeding and postoperative perioperative fluid build-up can thus enhance hernia repair recovery. Tranexamic acid is a man-made lysine analogue which prevents fibrinolysis and has undergone extensive research in reducing perioperative bleeding. Topical use has a high level of local antifibrinolytic activity and minimal systemic exposure and has demonstrated a decrease in blood loss and drainage in a variety of surgical specialties. Current randomized trials in breast and reconstructive surgery have shown variable findings on the prevention of seroma and hematoma, with a few showing reduced volumes of drainage or fluid complications. Present meta-analyses are also in favour of topical tranexamic acid to minimise the blood loss but also highlight the heterogeneity across procedures
- Conditions
- Umbilical Hernia Repair
- Being tested
- Topical Tranexamic Acid Spray, No Topical Tranexamic acid
- Keywords
- Umbilical Hernia, Tranexamic Acid, seroma
- Medical subject headings
- Hernia, Umbilical, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Tranexamic Acid SprayDrug
In the intervention group, a mesh will be applied and adequate hemostasis established then 1 g tranexamic acid will be sprayed all over the operative field in total volume of 10 mL of normal saline just before wound closure. Wound closure in the control group will be done without the use of topical tranexamic acid. Operative time, predicted intraoperative bleeding, mesh properties, to place drain, and intrasurgery complications will be recorded
No Topical Tranexamic acidDrug
Every patient will receive standardized elective open mesh repair of umbilical hernia surgery with the same operative technique, mesh position, preoperative perioperative antibiotic prevention and postoperative analgesic regimen within the limits of possibilities. Wound closure in the control group will be done without the use of topical tranexamic acid. Operative time, predicted intraoperative bleeding, mesh properties, to place drain, and intrasurgery complications will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Topical Tranexamic Acid Spray | Experimental | Not described Receives: Drug: Topical Tranexamic Acid Spray |
| No Topical Tranexamic Acid Spray | Placebo comparator | Not described Receives: Drug: No Topical Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Postoperative Seroma
A post procedural presence of pale or clear, straw-colored swelling on the site of a surgery that occurred or happened within 30 days since the operation and has been identified clinically and had to be confirmed by the ultrasonographic method, in case of uncertainty
Measured: 30 days
Rate of Postoperative Hematoma
It is a localized pool of blood or clot at the operative site that occurs in the clinically and or ultrasonographically-it can be detected within 30 days after surgery.
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 posted28 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Hernia RepairStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Mudassar Saeed Pansota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
- Investigators
- Saleh Tariq Kazi, MBBS, Principal investigator, Pkistan Railway Hospital, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845370
- Sponsor's protocol ID
- Pakistan Railway Hospital
- Other IDs
- Pakistan Railway Hospital
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Tranexamic Acid Spray Versus No Spray on Postoperative Seroma and Wound-Related Outcomes Following Mesh Repair of Umbilical Hernia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07845370
- Acronym / sponsor ID
- Pakistan Railway Hospital
- Conditions
- Umbilical Hernia Repair
- Keywords
- Umbilical Hernia, Tranexamic Acid, seroma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Dr Mudassar Saeed PansotaUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 28 Sep 2026 (actual)
- 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.
Umbilical hernia is a type of ventral hernia that occurs commonly in adulthood, and mesh reinforcement is well established since there is a reduced recurrence rate when compared to suture repair. However, the repair of meshes could prove to be complex due to seroma, hematoma, wound infection, pain, and other surgical-site events.3 Seroma formation is considered clinically significant due to its ability to be painful, recurrent outpatient care, aspiration, infection, and slow wound healing.
Detailed description
Surgical techniques that minimize bleeding and postoperative perioperative fluid build-up can thus enhance hernia repair recovery. Tranexamic acid is a man-made lysine analogue which prevents fibrinolysis and has undergone extensive research in reducing perioperative bleeding. Topical use has a high level of local antifibrinolytic activity and minimal systemic exposure and has demonstrated a decrease in blood loss and drainage in a variety of surgical specialties. Current randomized trials in breast and reconstructive surgery have shown variable findings on the prevention of seroma and hematoma, with a few showing reduced volumes of drainage or fluid complications. Present meta-analyses are also in favour of topical tranexamic acid to minimise the blood loss but also highlight the heterogeneity across procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Tranexamic Acid Spray | Experimental | Drug: Topical Tranexamic Acid Spray |
| No Topical Tranexamic Acid Spray | Placebo comparator | Drug: No Topical Tranexamic acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18-65 years.
- Either gender.
- Patient has primary umbilical hernia.
- To have elective umbilical hernia open meshes repair planned.
- Hernia defect that can be repaired with the help of the standardized mesh technique that was used in the study.
Key exclusion criteria (13 listed)
- • Emergency with incarcerated, obstructed, or strangulated umbilical hernia.
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 |
|---|---|---|
| Topical Tranexamic Acid SprayIn the intervention group, a mesh will be applied and adequate hemostasis established then 1 g tranexamic acid will be sprayed all over the operative field in total volume of 10 mL of normal saline just before wound closure. Wound closure in the control group will be done without the use of topical tranexamic acid. Operative time, predicted intraoperative bleeding, mesh properties, to place drain, and intrasurgery complications will be recorded | Drug | Topical Tranexamic Acid Spray |
| No Topical Tranexamic acidEvery patient will receive standardized elective open mesh repair of umbilical hernia surgery with the same operative technique, mesh position, preoperative perioperative antibiotic prevention and postoperative analgesic regimen within the limits of possibilities. Wound closure in the control group will be done without the use of topical tranexamic acid. Operative time, predicted intraoperative bleeding, mesh properties, to place drain, and intrasurgery complications will be recorded | Drug | No Topical Tranexamic Acid Spray |
Primary outcome
Rate of Postoperative Seroma
Time frame: 30 days
A post procedural presence of pale or clear, straw-colored swelling on the site of a surgery that occurred or happened within 30 days since the operation and has been identified clinically and had to be confirmed by the ultrasonographic method, in case of uncertainty
Rate of Postoperative Hematoma
Time frame: 30 days
It is a localized pool of blood or clot at the operative site that occurs in the clinically and or ultrasonographically-it can be detected within 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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.
mudassar pansota, MS urology contact
Saleh Tariq Kazi, MBBS principal investigator
Pkistan Railway Hospital, Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Tranexamic Acid Spray and No Topical Tranexamic acid in people with Umbilical Hernia Repair, run by Dr Mudassar Saeed Pansota at 1 site in Pakistan.
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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 30 Sep 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saleh Tariq Kazi, MBBS (03100089237, salehtk36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Postoperative Seroma (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.