| Experimental Group |
Group I |
Forty (40) participants received intravenous Tranexamic acid 10 – 15 minutes before abdominal incision in combination with tourniquet tying. |
Group 1 were given a bolus of intravenous tranexamic acid injection of 10 mg/kg (maximum 1 g) over 10 minutes, 15 minutes (onset of action is 5-15 minutes) before abdominal incision, followed by a continuous infusion of 1 mg/kg/h added to 1 L of saline that ran for 10 hours (maximum of 1 g/10 hours) in combination with tying tourniquet17 |
Under appropriate anaesthesia, the patient was cleaned, draped and normal standard surgical protocol for myomectomy was observed. A midline or Pfannenstiel incision was made on the abdominal skin. This was deepened by sharp and blunt dissection into the peritoneal cavity. The uterus was delivered into the wound after noting intraabdominal findings and location of the myomas. Foleys catheter as an improvised tourniquet was then tied (in both groups) at the base of the uterus close to the insertion of the uterosacral ligaments during the surgery3. This was tied in such a way that it temporarily impedes the blood supply from the uterine vessels and the infundibulo-pelvic ligament.3. The fallopian tubes and the ovaries were carefully excluded from the line of the tourniquet to avoid direct compression and necrosis.3 A single anterior and longitudinal incision, as much as possible was made and all the myoma nodules shelled out. After removing the myomas, the uterus was reconstructed using vicryl 2. (In cases where the endometrium was breached this was closed with interrupted stitches using vicryl 2/0 or 0.) Tourniquet was then removed and hemostasis ensured. The abdomen was then closed back in layers. Standard operating techniques were adhered to during all the procedure. |
40 |
|
| Control Group |
Placebo |
Group 2 received only placebo (water for injection) given as bolus intravenous injection over 10 minutes, about 15 minutes before abdominal incision followed by a continuous infusion of an equivalent water for injection (volume equivalent to 1 mg/kg/h of tranexamic acid) added to 1 L of saline that ran for 10 hours in combination with tying tourniquet. The volume of bolus water for injection was the same as tranexamic acid volume of bolus injection, calculated mg/kg, for each patient17. |
Group 2 received only placebo (water for injection) given as bolus intravenous injection over 10 minutes, about 15 minutes before abdominal incision followed by a continuous infusion of an equivalent water for injection (volume equivalent to 1 mg/kg/h of tranexamic acid) added to 1 L of saline that ran for 10 hours in combination with tying tourniquet. The volume of bolus water for injection was the same as tranexamic acid volume of bolus injection, calculated mg/kg, for each patient17. |
Under appropriate anaesthesia, the patient was cleaned, draped and normal standard surgical protocol for myomectomy was observed. A midline or Pfannenstiel incision was made on the abdominal skin. This was deepened by sharp and blunt dissection into the peritoneal cavity. The uterus was delivered into the wound after noting intraabdominal findings and location of the myomas. Foleys catheter as an improvised tourniquet was then tied (in both groups) at the base of the uterus close to the insertion of the uterosacral ligaments during the surgery3. This was tied in such a way that it temporarily impedes the blood supply from the uterine vessels and the infundibulo-pelvic ligament.3. The fallopian tubes and the ovaries were carefully excluded from the line of the tourniquet to avoid direct compression and necrosis.3 A single anterior and longitudinal incision, as much as possible was made and all the myoma nodules shelled out. After removing the myomas, the uterus was reconstructed using vicryl 2. (In cases where the endometrium was breached this was closed with interrupted stitches using vicryl 2/0 or 0.) Tourniquet was then removed and hemostasis ensured. The abdomen was then closed back in layers. Standard operating techniques were adhered to during all the procedure.
Estimated blood loss was calculated using the Gravimetric method: This method involved weighing abdominal packs/sponges before and after use on a scale. The pre-weighed sterile abdominal packs (weighed prior to sterilization) were used for blood loss on the sterile field while pre-weighed perineal pads were used for blood loss on the floor and other surfaces. The difference in weight between dry and soaked sponges was multiplied by 1.050 (blood density in gm./ml) to convert to volume in milliliter and this provided an estimate of blood loss1, 17. The amount of blood in the suctioning apparatus was added to what was calculated by the gravimetric method to estimate total blood loss. The site(s), size(s), number, volume and weight of the fibroid was also noted. The volume was calculated by the principle of Archimedes while a digital weighing scale (measuring to the nearest 0.01kg/10gm) was used to determine the weight.
The need or otherwise for additional anti-haemorrhagic agents to manage intra-operative and post- operative haemorrhage was recorded systematically. Need for blood transfusion and the number of units transfused were also documented. This need was determined by the anaesthetist’s assessment of acceptable blood loss and clinical assessment of vital signs. The acceptable blood loss was obtained by: Hb threshold of 10 g/dl, therefore allowable blood loss was considered equal to total Blood volume (Pre-operative Haemoglobin – Haemoglobin threshold/Pre op Haemoglobin)1.
The duration of the operation was noted and for the purpose of this study is defined as from uterine incision to the last stitch on the uterus1. Vital signs was obtained at 2 hours post - operation.
After the operation, each patient was taken to the recovery room and subsequently transferred to the gynaecological ward. In the ward, each patient was on nil per oris for twenty four hours; intravenous fluids for hydration and calories was given for at least twenty four hours after which she was commenced on graded oral intake. Parenteral antibiotics and Analgesics were given for forty-eight hours and changed to oral medications afterwards. Continuous bladder drainage was done for twenty four hours. Stitches were removed on the seventh or eighth day post operation (depending on if it was a vertical or Pfannenstiel incision) or not at all if it was absorbable subcuticular. The patient was discharged home for follow up in the gynaecological clinic one week later.
Post-operative investigations similar to what had been taken preoperatively were taken 24 hours after surgery, in essence, haemoglobin concentration, haematocrit, full blood count and bedside clotting time. Protective equipment |
40 |
Placebo |