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.