Methods Decreasing Bleeding in Open Myomectomy

Status

Status unknown

Phase

Phase 4

Enrollment

105 participants (estimated)

Sponsor

Cairo University · Other

Design

Randomized · Double masking

Countries

1 country

Egypt

Start

15 Mar 2023

Primary completion

30 Oct 2023 (estimated)

Completion

30 Nov 2023 (estimated)

First posted

10 Apr 2023

Last update posted

10 Apr 2023

Conditions

Misoprostol Allergy · Oxytocin Allergy · Tranexamic Acid Allergy · Ethamsylate Allergy · Myoma · Blood Loss, Surgical

Uterine leiomyomas (fibroids or myomas) are benign, smooth muscle tumors of the human uterus. Most myomas are asymptomatic (symptomless) and are discovered incidentally during a routine pelvic examination or imaging studies and have a lifetime incidence of approximately 70% in the general population . However, Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. The most common clinical symptoms include abnormal uterine bleeding, dysmenorrhea, pelvic pain, infertility, and recurrent pregnancy loss The standard treatment of symptomatic leiomyomas is Abdominal myomectomy Blood loss during myomectomy can be intra-operative or postoperative and with hematoma formation. The average volume of blood loss during abdominal myomectomy is 200 to 800 ml. massive blood loss associated with the dissection of huge fibroids renders myomectomy a more technically challenging procedure than hysterectomy. Sometimes myomectomy is converted to hysterectomy intra-operatively when bleeding becomes heavy and uncontrollable or when it is impossible to reconstruct the uterus because of the many defects left by removal of multiple myomas . Many techniques are used to reduce blood loss during myomectomy; preoperative measures such as correction of preoperative anemia associated with menorrhagia may be treated with iron supplementation, use of gonadotropin (GHG) triggers prior to surgery. Intra-operative measures as use of tourniquet around the uterus during the operation, injections of Vasopressin or other vasopressors as epinephrine in the uterine muscle and use of ecbolic (misoprostol, oxytocin, and carbetocin etc.). Uterine artery ligation, embolization, or internal iliac artery ligation may also be used to avoid hysterectomy when heavy bleeding is anticipated or occurs during myomectomy

• Active comparator

  misoprostol

  15 patients will receive 800 microgram (tablet 200mcg X 4) misoprostol (Misotac 200 mcg, SIGMA pharmaceutical, Egypt) rectally one and half hour before operation.

• Active comparator

  Tourniquet

  (15 patient): The operation will be performed with the use of Foleys catheter as an improvised tourniquet applied at the base of the uterus then infiltration myometrium overlying the leiomyoma with a solution composed of Bupivacaine Hcl 0.25% and 0.5 mg of epinephrine

• Active comparator

  Carbetocin

  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.

• Active comparator

  Oxytocin

  15 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.

• Active comparator

  combined TXA and ethamsylate

  (Patient 15): 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.

• Active comparator

  vasopressin

  15 women will receive terlipressin (Glypressin, Ferring, Egypt) intramyometrial injection of one ampoule of vasopressin containing 20 units in1 ml after dilution in 19 ml of normal saline during myomectomy.

• Active comparator

  bupivacaine and epinephrine

  15 women in which the 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).

1. blood loss

   Time frame · 3 hours

   Registry description

   the estimated intra-operative blood loss in ml