The aim of study:
The aim of the study is to compare the effectiveness of a single preoperative dose of rectal
misoprostol, intramyometrial oxytocin, intramyometrial carbetocin, combined iv TXA acid and
ethamsylate and peri cervical tourniquet for the reduction of blood loss during of abdominal
myomectomy.
Methodology:
Type of Study: Prospective randomized comparative clinical trial Study Setting: This study
will be conducted in Cairo University, kasr al-ainy hospitals, Maternity hospital in
operative theater.
Study Period: 6 months from April 2023 to October 2023. Study Population: Patients will be
recruited in this study from those attending gynecology ward at Kasr al-ainy hospitals,
Maternity hospital who are 25-48 years old with symptomatic uterine myoma indicating
operative management, abnormal uterine bleeding or bulk-related symptoms, females with
infertility or recurrent pregnancy loss, pressure symptoms, and large myoma(s).
Basic assessment:
Name, Age, Parity, Occupation, Residency and Special habits.
· Present history: History of onset, course and duration of agonizing symptoms, history of
HMB, history of infertility, history of pelvic pain.
• Obstetric history: History of previous abortion, ectopic pregnancy, previous cesarean
section and interval between cesarean deliveries.
· Menstrual history: Age of menarche and LMP.
· Past history: History of medical disorders, drug therapy or allergy, history of
appendicitis - in particular, appendix rupture, history of exposure to radiation treatment
for cancer, history of Gynecological infections (PID), history of abdominal infections e.g.:
peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.
• Family history: Family history of uterine myoma, family history of uterine cancers.
Examination
General examination includes blood pressure, heart rate, body temperature, head& neck
examination, chest, heart, sign of anemia, height (in cm) and weight (in kg)
measurements to calculate the Body mass index (The formula for BMI is weight in
kilograms divided by height in meters squared).
Local clinical examination: assessment of maternal health, abdominal and bimanual
examination, speculum examination to roll out any vaginal or cervical infection and
local cause of bleeding.
Preoperative investigations (Complete blood picture, blood group, RH, Kidney Function
Test , Liver Function Test , random Blood Sugar , urine analysis, Coagulation profile).
Ultrasonography examination (abdominal / vaginal) and MRI: to assess the following data:
Presence of uterine myoma, size and site of myoma, uterine size, roll out any adnexal mass.
Intervention
All women will be randomly assigned to either:
Group A (misoprostol) (25 patient): who will receive 800 microgram (tablet 200mcg X 4)
misoprostol (Misotac 200 mcg, SIGMA pharmaceutical, Egypt) rectally one and half hour before
operation.
Group B (Tourniquet) (25 patient): The operation will be performed with the use of Foleys
catheter as an improvised tourniquet applied at the base of the uterus close to the insertion
of the uterosacral ligaments a minor hole through the broad ligament on either side of the
uterus will be made, the catheter will be passed through the two holes and knotted firmly
anteriorly around the uterus, the tourniquet will be tensed in stepwise manner by
alternatively holding with a clamp, pulling on the tourniquet, and again holding with another
clamp in such a way that it temporarily impedes the blood supply from the uterine vessels.
The fallopian tubes, the ovaries, and the infundibulopelvic ligament are kept away to avoid
compression by tourniquet then operation will be performed after infiltration of the serosa
and / or myometrium overlying the leiomyoma before uterine incision with a solution composed
of 50 ml Bupivacaine Hcl 0.25% (Bucain® Weimer pharma, for Actavis Group PTC) and 0.5 mg of
epinephrine Hcl (2 vials of Epinephrine® 0.25mg/1ml Misr Co. for Pharmaceutical Industries).
The solution will be prepared just before the procedure. Before each infiltration, aspiration
will be performed to avoid intravascular injection.
Group C (Carbetocin) (25 patients): intramural; preparation of 100 μg of carbetocin ((Pabal,
Ampoule 100 mcg in 1 ml, Carbetocin; FERRING, North York, Canada) diluted within 10 cm of
saline (0.9%) in sterile syringe then will inject the substance into the multiple sites
intramyometrial in a circumferential manner 1-2 cm away from the margins of the myoma in the
planned uterine-incision site just before uterine incision for myoma extraction.
Group D (Oxytocin) (25 patients): who will receive oxytocin 40 I.U. intramyometrially
(Syntocinon, Ampule 10 I.U. in 1 ml, Oxytocin; NOVARTIS, Basel, Switzerland) then will inject
the substance into the multiple sites intramyometrial in a circumferential manner 1-2 cm away
from the margins of the myoma in the planned uterine-incision site just before uterine
incision for myoma extraction.
Group E (combined TXA and ethamsylate) (Patient 25): will receive 1 g tranexamic acid (2
ampoules of kapron 500 mg, kapron®, Amoun, Egypt) and 500 mg ethamsylate (2 ampoule of
ethamsylate 250 mg, Dicynone, OM pharma, Geneva, Switzerland) IV 10 minutes before skin
incision by slowly intravenous injection Then infusion was applied continuously for 24 hours
within 1 liter of saline as 1 mg/kg/hour.
The operations will be performed by the same team to avoid any bias related to surgical
skills. The abdomen will be exposed through Pfannenstiel incision, after skin incision, the
subcutaneous fat and abdominal fascia will be opened crosswise, and the rectus muscle will be
opened on the midline. The parietal peritoneum will be opened longitudinally to reach the
pelvic cavity. Subsequently, a self-retaining retractor will be inserted, and intestine will
be packed. Uterus will be inspected for the number, location, and shape of myomas, and other
pelvic organs will be inspected for associated pathology. Uterine incisions on top of myoma
will be performed. When possible, uterine incisions will be performed on the anterior wall or
the fundus in order to reduce postoperative adhesions. The incision will be performed using
monopolar diathermy. Intracapsular enucleation of myomas will be performed by gently
dissecting between the myoma and the pseudo capsule. The myoma will be grasped by Collins
forceps and gently enucleated out. Meticulous hemostasis will be secured by low-voltage
coagulation (≤30 W) of feeding vessels. Myoma bed will be closed by 1 or 2 layers (The
uterine defects will be closed with sutures in layers. If the myometrial defect is deep (>2
cm), two layers may be needed to approximate the tissue and achieve hemostasis) of
interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). The
serosa is closed with a running suture; we used size 2-0 polyglactin 910 (Vicryl). At the end
of the surgery, 1 intraperitoneal suction drain will be routinely used and the volume in the
drain bag will be measured every 12 hours. (Ultramed, Nelaton drain-24 FG, Assiut City,
Egypt). in all patients the drains will be removed on the second postoperative day unless
otherwise indicated. Number and size of myomas will be recorded. Myoma size represent the
mean size of each myoma. Enucleated myomas will be sent to histopathology.
Total bleeding was calculated as intraoperative and postoperative blood loss. Intraoperative
blood loss was estimated by the scrub nurse by drying up all blood in the surgical field with
swabs and then weighing them. The weight of the dry surgical swabs (roughly 28 g for each 30
- 30 cm abdominal swabs) is measured before use and after being wet or soaked by blood. A
highly accurate digital balance is used to measure the weight in grams. The weight difference
is translated into the blood loss considering that 1 g is equal to 1 mL blood. The quantity
of blood loss (mL) equals (weight of the used materials - weight of the materials prior to
the surgery) in addition to the blood collected in the suction apparatus after evacuation.
Meanwhile, postoperative blood loss was defined as the blood volume found in the suction
drain.
All study groups will be checked for vital signs (blood pressure, heart rate, and respiratory
rate) before and after myomectomy. The following routine investigations, CBC, PT, PTT, ALT,
AST and serum creatinine, will be performed preoperatively for all groups, and CBC will be
repeated on the third postoperative day. Any adverse effects in either group will be
recorded. The need for blood transfusion either intraoperatively or postoperatively will be
also recorded. Intraoperative blood transfusion will be governed by clinical condition and
amount of blood loss. Postoperative blood transfusion will be indicated if hemoglobin (Hb)
percentage was less than 7 g/dl with relevant clinical manifestations. Women will be reviewed
again 1 week after the operation. In addition to the usual follow-up, women will be checked
for manifestations of thrombosis.