Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy
Condition: Myoma;Uterus
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 4

Summary: 
      Submucous myomas represent one of the main indications of operative hysteroscopy. Since 1976
      when Neuwirth and Amin reported the first five cases of excision of submucous myomas ,
      several techniques have been developed in order to render hysteroscopic myomectomy a safe and
      effective procedure .

      Hysteroscopic myomectomy is currently considered the "gold standard" minimally invasive
      approach for the treatment of symptomatic submucous myomas . Patients undergoing
      hysteroscopic myomectomy are liable to significant blood loss, and hemodynamic and
      hematological disturbances. Excessive bleeding during hysteroscopic myomectomy remains a
      major challenge for the endoscopic gynecological surgeons. Many interventions were introduced
      to reduce the risk of bleeding during myomectomy. These include the use of utero-tonics such
      as oxytocin, or the use of anti-fibrinolytics such as tranexamic acid . The potential
      advantage of oxytocin infusion during hysteroscopic myomectomy is that it can maintains
      uterine contractility throughout the procedure, and thus, reduce blood loss .

      Carbetocin (1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic
      agonist analogue of the human oxytocin. When injected to a woman, it induces uterine
      contractions . Although many interventions have been described to reduce the intraoperative
      blood loss during hysteroscopic myomectomy, there is a need for a well-designed randomized
      controlled trials to identify the most efficient interventions, with reasonable safety
      profiles, to help the perform a safe and curative surgery.
    

Detailed description: 
      All patients will have preoperative evaluation by gynecologists and anesthetists, with
      history taking and pelvic examination. A TVS scan will be done to determine the number, size
      and location of the myomas, and evaluate the myometrial free margin (the minimum thickness
      between the outer edge of the myoma and inner edge of the uterine serosa), which was found to
      be ideally ≥ 10 mm (11). Prior office diagnostic hysteroscopy will be performed for
      evaluation of the number, location and grade of the submucous myomas, and assessment of the
      endocervical canal and uterine cavity and the position of the tubal ostia in order to aid
      orientation. Preoperative full blood count, serum creatinine, fasting blood glucose, liver
      enzymes, coagulation profile ( INR), and viral markers will be done for all the patients.
      Monopolar resectoscopic myomectomies will be scheduled in the proliferative phase of
      menstrual cycle by a single experienced operator.

      After induction of general anesthesia, immediately before the operation, participants will
      receive either 1 ml of carbetocin (100 mcg/ml) IV over 1 minute (study group) or 1 ml of
      sodium chloride 0.9% IV over 1 minute (control group). The procedure will be done using the
      available standard setup and the distending solution used will be 1.5% glycine. A drape with
      a fluid-collection pouch (Lingeman 3 in 1 Procedure Drape, Lingeman Medical Products, Inc.,
      Indianapolis, IN) placed beneath the woman's buttocks will be used to collect outflow fluid
      escaping between the cervix and sheath to prevent spillage of irrigating fluid onto the
      floor. Fluid inflow and outflow will be monitored every 3-5 minutes. The outflow fluid will
      be measured to the nearest milliliter. The inflow and outflow volumes of the distension
      solution will be carefully monitored continuously during the procedure by nurses not involved
      in the study under the current monitoring protocol at the operating theater. The procedure
      would be terminated if the fluid imbalance reached 1 L.

      After completing the procedure, the surgeon completed a record sheet for rating of bleeding
      amount and the quality of operative view. Postoperative full blood count will be done for all
      patients 24 hours after the procedures. Preoperative and postoperative hemoglobin and
      hematocrit, the need for blood transfusion, the duration of operation, any operative
      complications and medication adverse effects will be recorded.
    

Intervention name(s): Carbetocin; Sodium chloride 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): (1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic agonist analogue of the human oxytocin; Physiological solution will be used as placebo
Intervention MeSH terms: Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial (RCT).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention