Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Study Overview
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Brief Summary
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A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .

Detailed Description
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This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .

Official Title
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Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.

Conditions
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Submucous Leiomyoma of Uterus

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Vasopressin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy grade 0 and grade 1 submucous myomas less than 5 centimeters in diameter Exclusion Criteria: Patients with grade 2 submucous myoma or more patients with submucous myomas larger than 5 cm in diameter postmenopausal women patients received GnRh analogue in last 6 months patients with anticoagulant therapy patients with endometrial premalignant or malignant pathologies patients with cardiovascular diseases, asthma or impaired kidney functions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: misoprostol group<br>20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation. | Drug: Misoprostol<br>* prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy<br>* Other names: Misotac;|
| Active Comparator: vasopressin group<br>20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy | Drug: Vasopressin<br>* one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative bleeding | subjective assessment of bleeding by the surgeon. | start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure | 
| operative time | time needed for completion of myomectomy procedure | start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure | 
| haemoglobin and hematocrit deficit | haemoglobin and hematocrit values before and after myomectomy | 24 hours before myomectomy and 24 hour after myomectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of visual clarity | visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter) | start with the first resectoscope myoma cut till the completion of myoma resection | 
| Fluid deficit | calculation the fluid deficit between in flow volume and outflow volume | start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure | 
| time need for cervical dilatation | time needed to dilate the cervix to admit the operative hysterescope | start from grasping the cervix till insertion of hysterescope |