Clinical trial NCT04996498: Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy
Official title: Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy: A Randomized Double Blinded Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leiomyoma
Keywords: Hysteroscopic Myomectomy
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2021-08-09
Enrollment: 60
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled double blinded clinical trial.
Primary purpose: OTHER

Brief summary: There is no previous study on the hemostatic effect of intrauterine instillation of oxytocin in hysteroscopic myomectomy. All previous studies focused on intravenous administration of oxytocin.

This trial may modify the surgical environment in hysteroscopic myomectomy by decreasing intraoperative bleeding to a degree that the amount of distention medium required for uterine distention will be reduced with a better visibility and shorter operation time.

The standard treatment of symptomatic myomas is hysterectomy for women who have completed childbearing period, and myomectomy for women who wish to preserve fertility hysteroscopic myomectomy currently is the gold standard minimally invasive procedure for the management of symptomatic submucous fibroids. Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, via the correct distending pressure, continuous irrigation and the use of electrosurgery to control bleeding. Prolonged procedures that need continuous irrigation under high pressure are associated with higher risk of excessive fluid absorption and intravasation syndrome due to opened blood vessels within the myometrial, moreover, the thermal damage of the healthy tissues is increased with the use of the coagulation current.

Oxytocin receptors exist in the non-pregnant uterus but the concentration of the receptors is much lower than in pregnancy. this is why the clinical use of oxytocin outside of pregnancy is limited Oxytocin acts on oxytocin receptors in the myometrium and fibroid tissue leading to uterine contraction and constriction of uterine vasculature due to uterine contraction and vaso-constrictive effect of oxytocin thus reducing uterine perfusion and results in reducing intraoperative bleeding.

Detailed description: Patients will be subjected to:

1. History taking: including personal history, menstrual and obstetric history, medical and surgical history, medications.
2. Clinical examination; General and local with special concern about:

   1. Size and position of the uterus
   2. Transvaginal ultrasound to determine the number, size, location of fibroids and evaluation of the myometrial free margin that is defined as the minimum thickness between the outer edge of the fibroid and the inner edge of uterine serosa.
3. Laboratory evaluation: All participants will have routine blood tests: Complete Blood Count (CBC), serum creatinine, viral markers, coagulation profile and liver function tests.

Surgical procedure:

1. Office hysteroscopy will be performed the day before the procedure with the use of a 2-9 mm telescope with continuous-flow sheath (Hopkins II telescope 30 degrees: Karl storz) to assess and confirm the fibroid location, its intracavitary portion and to exclude any associated uterine pathology).
2. Hysteroscopy will be performed in the early proliferative phase (postmenstrual) in dorsal lithotomy position under general anesthesia, cervical dilatation will be done with Hegar dilators then resection of the submucous fibroid using monopolar resectoscope using 1,5% glycine as a distension medium by single operator to avoid inter-observer variability.
3. The intervention group (oxytocin group) will receive 10 IU of oxytocin for every 1000 ml of the distending medium (1,5% Glycine). While in the control group a sterile bacteriostatic water ampule in the same form will be added to every 1000 ml of the distending medium (1,5% Glycine).
4. After completing the procedure, the surgeon will complete a record scale to document estimated blood loss, rating the bleeding (0: no bleeding, I; mild bleeding, II: moderate bleeding, III: severe bleeding, IV: severe bleeding with clots). Also will document the clarity of visual field using 3 point likert scale as (poor, fair, good).
5. Post operative settings:

   * the duration of surgery and the volume of injected media will be calculated and documented.
   * all patients will be subjected to postoperative hemoglobin 24 hours after the procedure, any intraoperative or postoperative complications will be documented

Eligibility criteria: Inclusion Criteria:

1. Symptomatic patient (Menorrhagia, recurrent pregnancy loss or infertility).
2. 1 or 2 submucous uterine myoma diagnosed by ultrasound with a diameter less than 4 cm
3. Myoma with FIGO 0 or 1.
4. Body mass index less than 35.

Exclusion Criteria:

1. Pregnancy
2. Active pelvic infection
3. history of bleeding disorder or patient on anti-coagulant.
4. hepatic and renal diseases.
5. history of ischemic heart disease.
6. Patients with uterine structural abnormality or uterine septum.
7. Present or history of cervical or uterine cancer.
8. Preoperative administration of gonadotropin-releasing hormone analogues or danazol.
9. Allergy to glycine.
10. Patients with hypercoagulopathy.

Primary outcomes:
measure: the change in hemoglobin level 24 hours after the procedure surgery
timeFrame: preoperative and 24 hour postoperative
measure: the change of hematocrit level 24 hour after the procedure
timeFrame: preoperative and 24 hour postoperative
Secondary outcomes:
measure: the surgeon rating of intraoperative bleeding and the visual field quality of operative view,
timeFrame: immediately postoperative
measure: the duration of surgery, intraoperative
timeFrame: immediately postoperative
measure: intraoperative and postoperative complications
timeFrame: intraoperative and within the first 24 hours postoperative
measure: the surgeon rating the visual field
timeFrame: immediately postoperative
measure: the volume of distension media used intraoperative
timeFrame: immediately postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
state: Abbasia
Study officials:
affiliation: AinShams MH
name: amir Mahfouz, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Spiezio Sardo A, Mazzon I, Bramante S, Bettocchi S, Bifulco G, Guida M, Nappi C. Hysteroscopic myomectomy: a comprehensive review of surgical techniques. Hum Reprod Update. 2008 Mar-Apr;14(2):101-19. doi: 10.1093/humupd/dmm041. Epub 2007 Dec 6.
citation: Vilos GA, Allaire C, Laberge PY, Leyland N; SPECIAL CONTRIBUTORS. The management of uterine leiomyomas. J Obstet Gynaecol Can. 2015 Feb;37(2):157-178. doi: 10.1016/S1701-2163(15)30338-8.
citation: Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
citation: Maggi M, Magini A, Fiscella A, Giannini S, Fantoni G, Toffoletti F, Massi G, Serio M. Sex steroid modulation of neurohypophysial hormone receptors in human nonpregnant myometrium. J Clin Endocrinol Metab. 1992 Feb;74(2):385-92. doi: 10.1210/jcem.74.2.1309835.
citation: Atashkhoei S, Fakhari S, Pourfathi H, Bilehjani E, Garabaghi PM, Asiaei A. Effect of oxytocin infusion on reducing the blood loss during abdominal myomectomy: a double-blind randomised controlled trial. BJOG. 2017 Jan;124(2):292-298. doi: 10.1111/1471-0528.14416. Epub 2016 Nov 15.