Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy

NCT04996498 | Completed DMC

• 1 other identifier: Hysteroscopic Myomectomy:
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyoma

Keywords

Hysteroscopic Myomectomy

Outcome Measures

Primary Outcomes (2)

• the change in hemoglobin level 24 hours after the procedure surgery

  the change of hemoglobin postoperative to know the effect of oxytocin compared to placebo in reducing blood loss. surgery compared to the pre-operative values to see if intrauterine instillation of oxytocin will reduce blood loss during hysteroscopic myomectomy

  preoperative and 24 hour postoperative

• the change of hematocrit level 24 hour after the procedure

  a follow up CBC is done 24 hour after the procedure to see the difference in hematocrit and know about the blood loss intraoperative

  preoperative and 24 hour postoperative

Secondary Outcomes (5)

• the surgeon rating of intraoperative bleeding and the visual field quality of operative view,

  immediately postoperative

• the duration of surgery, intraoperative

  immediately postoperative

• intraoperative and postoperative complications

  intraoperative and within the first 24 hours postoperative

• the surgeon rating the visual field

  immediately postoperative

• the volume of distension media used intraoperative

  immediately postoperative

Study Arms (2)

Group A (Oxytocin group):

ACTIVE COMPARATOR

30 women will undergo a hysteroscopic myomectomy with the use of 10 IU of oxytocin for every 1000 ml of the distending medium (1,5% Glycine ).

Drug: Oxytocin

Group B (Placebo group):

PLACEBO COMPARATOR

30 women will undergo hysteroscopic myomectomy with the use of a sterile bacteriostatic water ampule in the distending medium (1,5% glycine).

Other: sterile bacteriostatic water ampule

Interventions

Oxytocin DRUG

intrauterine Instillation of oxytocin in distention media used during Hysteroscopic Myomectomy

Also known as: syntocinon

Group A (Oxytocin group):

sterile bacteriostatic water ampule OTHER

a placebo drug similar in shape to oxytocin ampules

Group B (Placebo group):

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Active pelvic infection
• history of bleeding disorder or patient on anti-coagulant.
• hepatic and renal diseases.
• history of ischemic heart disease.
• Patients with uterine structural abnormality or uterine septum.
• Present or history of cervical or uterine cancer.
• Preoperative administration of gonadotropin-releasing hormone analogues or danazol.
• Allergy to glycine.
• Patients with hypercoagulopathy.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain shams university maternity hospital

Cairo, Abbasia, 11517, Egypt

Location

Related Publications (5)

• 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.

  PMID: 18063608 BACKGROUND

• 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.

  PMID: 25767949 BACKGROUND

• 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.

  PMID: 21345435 BACKGROUND

• 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.

  PMID: 1309835 BACKGROUND

• 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.

  PMID: 27862855 BACKGROUND

Related Links

• practice guidelines for the diagnosis and management of submucous leiomyomas. Journal of minimally invasive gynecology,

MeSH Terms

Conditions

Leiomyoma

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• amir Mahfouz, Master

  AinShams MH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The allocation will be concealed in sealed, sequentially numbered, white envelopes which will be prepared by a statistician where the drug will be covered with adhesive tape and handed over to the data collector. each woman will collect the corresponding sealed envelope directly from the data collector and it will be opened just before application of the drug. the surgeon, the assistant and the nurse performing the procedure and the patient will be blinded to the medication drug which will be used inside the distention medium.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistent lecturer

Model Details: Randomized controlled double blinded clinical trial.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 9, 2021
• Study Start: April 15, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)