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Leiomyoma

Myofibroma

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Reproductive Control Agents

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Amino Acids

Oxytocin

Hemostatics

Glycine

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 ).

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

intrauterine Instillation of oxytocin in distention media used during Hysteroscopic Myomectomy

a placebo drug similar in shape to oxytocin ampules

sterile bacteriostatic water ampule

amir Mahfouz, Master

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.

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

Randomized controlled double blinded clinical trial.

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.

Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy

Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy: A Randomized Double Blinded Control Trial

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

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

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).

Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, so, if oxytocin decrease blood loss intraoperative , the operation time will be reduced .

there are some operative complications as uterine perforation , cervical tear and fluid overload also, there is some adverse effects of oxytocin as arrythmia, nausea, vomiting , hypotension and abdominal pain

After completing the procedure, the surgeon will document the clarity of visual field using 3 point scale as (poor, fair, good)

glycine 1,5% is used as a distention media during procedure, each solution contain 1000 ml . counting the number of solution used intraoperative to calculate the amount of distension media used.

Ain Shams University

Ain Shams Maternity Hospital

assistent lecturer

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Tract Infections

Myoma

Patients underwent cold knife hysteroscopic myomectomy

Wanwan Xu, Doctor

Uterine fibroid are the most common benign tumor in the female reproductive system. Although many patients with uterine fibroid do not need to be treated because they are asymptomatic, some patients can experience compression, menorrhagia, pain, irregular bleeding or infertility. The symptoms caused by uterine fibroid are related to its location and size. Submucous fibroids constitute 5-10% of all uterine fibroids.The submucous hysteromyoma is the most likely to cause symptoms, often leads to menorrhagia, irregular bleeding or infertility.

Hysteroscopic myomectomy is a commonly used minimally invasive procedure. The submucous myoma can be resected out by endoscopic resectoscope with electricloop (unipolar and bipolar) . It can preserve the uterus and fertility, also effectively alleviate symptoms.

However, some specific complications have also followed，such as： hemorrhage，uterine perforation， pneumonedema，infections，adhesions，etc. Uterine perforation occurs when the electrode is working, there is a high risk of injury to adjacent anatomical structures. And even without perforation, sometimes thermal injury to adjacent organs may still be discovered in a few days after surgery.In addition，Many scholars have found that hysteroscopic electromyectomy has a higher risk of intrauterine adhesion than other intrauterine operations.

In order to reduce the damage caused by energy source, especially the adverse effects of thermal damage on the endometrium, the new methods of hysteroscopic myomectomy currently include: the hysteroscopic tissue removal (HTR) system, the cold loop myomectomy， the Hysteroscopy Endo Operative system (HEOS)，etc. Existing studies show that，These manipulation techniques did not cause the myometrium damage by radiofrequency energy source, greatly reducing the risk of postoperative intrauterine adhesions. The cold knife hysteroscopic myomectomy in this study is a series of procedures using cold instruments（mechanically, with scissor, grasping or morcellation） to remove uterine submucosal fibroids. The purpose of this surgical technique is to make the operation safe and effective, with greater emphasis on the anatomical and physiological integrity of the myometrial and endometrial layers. This study aims to evaluate the safety and efficacy of cold knife hysteroscopic myomectomy.

According to the inclusion and exclusion criteria，collecting the data of participants who have undergone cold knife hysteroscopic myomectomy. The investigators will analyze the safety and efficacy of cold knife hysteroscopic myomectomy through the collected data.

Hysteroscopic Myomectomy for Submucosal Myomas Without Energy Instruments

Total removal of intrauterine pathology with cold knife hysteroscopic myomectomy was defined as a successful operation. During the operation, whether the fibroids were successfully removed by B-ultrasound examination and naked eye

Using the cold knife method failed to remove the fibroids. During operative transfer to other surgical methods to remove submucosal fibroids, such as electrical cutting

hemorrhage, pneumonedema, or perforation were registered

Through the intraoperative blood loss assessment and preoperative and postoperative hemoglobin comparison

postoperative menstrual volume, menstrual period, anemia, postoperative fertility, postoperative intrauterine adhesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy	NCT04996498	Leiomyoma	Oxytocin sterile bacteri...	- 50 Years	Ain Shams Maternity Hospital
Hysteroscopic Myomectomy for Submucosal Myomas Without Energy Instruments	NCT06150521	Hysteroscopic M...		18 Years - 70 Years	The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy	NCT04996498	Leiomyoma	Oxytocin sterile bacteri...	- 50 Years	Ain Shams Maternity Hospital

Spots Global Cancer Trial Database for hysteroscopic myomectomy