MATERIALS AND METHODS
This study aimed to evaluate the role of intravenous tranexamic acid in reducing the perioperative blood loss in hysterectomy for benign conditions. The prospective randomized case-control study was carried out in the Department of Obstetrics and Gynaecology of Pt. B.D. Sharma PGIMS, Rohtak, on 150 patients planned for hysterectomy for benign conditions. Informed written consent was taken from every patient before the surgery. The required sample size was calculated based on the power of the 80% study and an α error of .05.
Patients were presenting for hysterectomy for any benign indication including abnormal uterine bleeding, menorrhagia, uterine fibroids, adenomyosis, pelvic pain, dysmenorrhea, pelvic organ prolapse or endometriosis, with age ≥ 18 years and willing to consent for the study and to receive IV tranexamic acid before hysterectomy were included in the study. The patients with known or suspected endometrial/ovarian/cervical cancer or dysplasia, those with known bleeding/clotting disorders or a history of thromboembolism, those with history of allergic reactions to tranexamic acid, those with uncontrolled current illness (cardiac, hepatic, renal, etc.) or defective color vision or those previously on tranexamic acid before surgery were all excluded from the study.
The women were randomized into two groups- Group I and Group II, according to the computer-generated randomization number sequence for two-arm study with 75 subjects in each group. Group I was not be given any drug, while Group II was given TXA in an intravenous bolus injection of 10mg/kg (maximum 1g) for 10 min about 30 min before incision. The total volume of blood loss (m) during the operation was measured by the gravimetric method by adding the volume of contents of the suction container (excluding the volume of the fluid used for irrigation in laparoscopic hysterectomy) (a) to the difference in weight (where 1.06g is equivalent to 1ml) between the dry (b) and wet (c) mops used during the surgery m=a+(c-b).
The mop used for skin and surface bleeding was discarded on opening the peritoneal cavity. The type of anesthesia given was noted. The weight of the hysterectomy specimen was measured. The total duration of surgery from skin incision to skin closure was noted. Requirements of blood transfusion intraoperatively and postoperatively up to 7 days of surgery were recorded. Complications in the postoperative period were recorded. Postoperative hemoglobin was measured on postoperative day 2. If hemoglobin was found to be <7g/dl, blood transfusion was done.
The primary outcome was intraoperative blood loss. The secondary outcome was the requirement of blood transfusion, the changes in hemoglobin after the operation, and the duration of hospital stay.