Topical Tranexamic Acid Spray Versus No Spray on Postoperative Outcomes Following Mesh Repair of Umbilical Hernia

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

• Topical Tranexamic Acid Spray (Drug): 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 acid (Drug): 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

Primary outcomes

• Rate of Postoperative Seroma [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 [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.

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* • 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.
  * 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

• Saleh Tariq Kazi, MBBS, Principal investigator, Pkistan Railway Hospital, Rawalpindi