Comparing Preoperative Vaginal Misoprostol, Intraoperative Oxytocin Infusion, Intravenous Carbetocin and Pericervical Hemostatic Tourniquet in Reducing Blood Loss During Abdominal Myomectomy, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Cairo University
- Enrollment
- 120
- Primary Endpoint
- Intraoperative blood loss
Study Overview
Brief Summary
The aim of the study is to compare the effectiveness of a single preoperative dose of vaginal misoprostol, intraoperative oxytocin infusion, IV carbetocin and pericervical tourniquet for the reduction of blood loss during of abdominal myomectomy.
Detailed Description
Uterine leiomyomas (fibroids) are the most common benign tumours among women. Fibroids are found in approximately 20% of women over 35 years of age. They are mostly asymptomatic, but in 20-50% of patients, fibroids may cause problems such as heavy menstrual bleeding, anaemia, pelvic pain and pressure,symptoms from extrinsic compression of the colorectal and urinary tract,recurrent abortion and infertility. Surgery is indicated for symptomatic uterine leiomyomas; hysterectomy for women who have completed childbearing (women > 40 years old), and myomectomy for women <40 years old who wish to preserve uterine and fertility .Myomectomy can be accomplished by laparotomy, laparoscopy, or hysteroscopy (transvaginal) approaches.
Uterine fibroids have a rich blood supply which may result in intensive bleeding during the myomectomy procedure.This surgical procedure may be associated with substantial morbidity, in particular major blood loss especially in abdominal myomectomy. Fletcher reported that 23% patients undergoing open myomectomy lost over 1000ml of blood. Other studies reported the operative blood loss range between 100 ml and 3000 mls. Blood transfusion can be required in up to 20% of the women during abdominal myomectomy and may require hysterectomy in up to 2% of patient undergoing abdominal myomectomy.
A number of interventions have been introduced to reduce bleeding rate during myomectomy:
- interventions on uterine arteries as peri cervical mechanical tourniquet, preoperative clamping or embolization of bilateral uterine and/or ovarian arteries (UAE)
- uterotonics as ergometrine, oxytocin, misoprostol, peri-operative injection of ascorbic acid, or intraoperative vasopressin or terlipressin injection (hormonal tourniquet) into myometrium , or intra-myometrial infiltration of bupivacaine plus epinephrine,
- myoma dissection techniques as use of laser, electrosurgery and chemical dissectors such as mesna.
- GnRH analogues reduce haemorrhage during surgery if used for 2-4 months preoperatively. GnRH analogues are expensive and may make removing fibroids difficult because of reduced distinction between capsule and myometrium.
However, these strategies may be associated with some complications, and some of these are ineffective or expensive or require extra steps before the actual procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 20-40 years.
- •1-5 symptomatic intramural, submucous or subserous myomas by ultrasound
- •Mean uterine fibroid size of 5-10 cm
- •Presented with abnormal uterine bleeding, dull lower abdominal pain, infertility or recurrent miscarriage and are candidates for abdominal myomectomy.
Exclusion Criteria
- •History of previous abdominal or pelvic surgery (laparotomy) except Cesarian section.
- •History of pelvic or ovarian endometriosis.
- •History of PID.
- •Patient with pedunculated subserous fibroid.
- •Patients who are candidate for laparoscopic or hysteroscopic myomectomy.
- •Allergy to misoprostol.
- •Hypertension, Diabetes Mellitus, Cardiac and pulmonary diseases.
- •Obesity BMI > 30 kg/m².
- •Anemia Hb < 10 g/dL.
- •Bleeding disorder or use of anticoagulation.
- •Preoperative use of hormonal therapy as GnRH analogues or oral contraceptive pills.
- •Postmenopausal.
Arms & Interventions
Misoprostol group
receive two tablets of 200µg misoprostol (Pfizer Limited, United Kingdom) administered into the posterior fornix of the vagina 1 hour before the onset of surgery
Intervention: Misoprostol 200mcg Tab vaginal (Drug)
Oxytocin group
After induction of general anaesthesia and immediately prior to the operation, an infusion of 30 IU oxytocin in 500 ml normal saline at a rate of 120 ml/h will be started during myomectomy.
Intervention: Oxytocin (Drug)
Carbetocin group
receive 100 μg IV Carbetocin (1ml) [Pabal, Ferring (UK)] in 5 ml saline over 1 minute just before skin incision
Intervention: Carbetocin (Drug)
pericervical tourniquet group
pericervical tourniquet using a Foley catheter size 18, which will be firmly tied at the level of the cervico-isthmic junction of the uterus before the uterine incision.
Intervention: pericervical hemostatic tourniquet (Procedure)
Outcomes
Primary Outcomes
Intraoperative blood loss
Time Frame: baseline
estimated by calculating the sum of canisters containing irrigation fluids and suctioned (ml)blood minus used irrigation solution plus the amount of absorbed blood in used sponges then converting weight with volume of blood loss as \[post-operative wet sponge weight in (grams) minus preoperative dry sponge weight (grams) which means 1 ml of blood weighs 1gm\].
Secondary Outcomes
- The need for blood transfusion(baseline)
- Anaesthesia time(with in 120 minutes)
- Preoperative and postoperative haemoglobin and haematocrit values(24 hours before and 24 hours after)
- Time of ambulation(within 12 hours postoperative)
- Operation time(within 120 minutes)
- Post-operative hospital stay(within 3 days postoperative)
- Perioperative blood pressure and HR(Up to 4 hours postoperative)
Investigators
Reham Hany Mohamed
assistant lecturer
Cairo University