Clinical trial NCT03892668: Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy.
Official title: Safety and Efficacy of Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myomectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Uterine leiomyomas (fibroids) are the most common benign tumors among women. Fibroids are found in approximately 20% of women over 35 years of age. In 20-50% of patients, fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract. 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 uterus and fertility.

Detailed description: Interventions:

Preoperative

* Full history, where demographic characteristics will be reported and examination to detect the size and mobility of uterus.
* Informed consent will be taken from patients.
* Trans-vaginal U/S to assess number, size, and types of myomas.
* Preoperative full labs (Hemoglobin, hematocrit, INR, liver enzymes and kidney functions)

Intra Operative

* Preoperative antibiotics will be given before the beginning of the operation. The operations will be performed as standard through a midline or Pfannenstiel incision by the same consultant gynecologist to ensure consistency of study procedures. All patients will receive general anesthesia. After the 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. The uterus will be inspected for the number, location, and shape of myomas. Other pelvic organs will be inspected for any associated pathology. When possible, uterine incisions will be performed on the anterior wall or 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 gently enucleated out. Meticulous hemostasis will be secured by low-voltage coagulation of feeding vessels. Myoma bed will be closed by 1 or 2 layers of interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). No mechanical tourniquet or local vasoocclusive drugs (e.g., vasopressin) will be used intraoperatively.
* The study will include patients scheduled for open abdominal myomectomy and will be divided into three equal groups.
* All the three groups will take a standard dose of 400 microgram of misoprostol rectally one hour before the operation.

Postoperative

* Estimation of Hemoglobin 6 hrs postoperatively and next day morning.
* Monitor Vital Signs and need for blood transfusion.
* Send myomas for pathology.

Eligibility criteria: Inclusion Criteria:

* • Age group (18-50) years old

  * Intramural or interstitial myomas (more than 5 cm)
  * Symptomatic myomas (heavy menstrual bleeding or pain during menstruation)
  * Abdominal myomectomy
  * No medical disorders
  * No coagulation disorders

Exclusion Criteria:

* • Age group (less than 18 yrs old)

  * Age group (more than 50 yrs old)
  * Subserous or submucous myomas
  * Laparoscopic or hysteroscopic myomectomy
  * Medical disorders (for example uncontrolled hypertension, diabetes mellitus, renal or hepatic disorders)
  * Coagulation disorders
  * Previous use of anticoagulant drugs
  * Previous myomectomy
  * Allergy to Tranexamic acid or oxytocin
  * Malignant features by U/S or examination
  * Pregnancy
  * Previous hormonal therapy (GnRH analogues)

Primary outcomes:
measure: Intraoperative Blood loss
timeFrame: during the operation
Secondary outcomes:
measure: Operation time
timeFrame: 1 hour
measure: Myomectomy time
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of medicine Cairo university
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: