Submucous Leiomyoma of Uterus
Conditions
Brief summary
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
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 .
Interventions
DRUGMisoprostol
prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy
DRUGVasopressin
one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe.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.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative bleeding | start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure | subjective assessment of bleeding by the surgeon. |
| operative time | start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure | time needed for completion of myomectomy procedure |
| haemoglobin and hematocrit deficit | 24 hours before myomectomy and 24 hour after myomectomy | haemoglobin and hematocrit values before and after myomectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of visual clarity | start with the first resectoscope myoma cut till the completion of myoma resection | visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter) |
| Fluid deficit | start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure | calculation the fluid deficit between in flow volume and outflow volume |
| time need for cervical dilatation | start from grasping the cervix till insertion of hysterescope | time needed to dilate the cervix to admit the operative hysterescope |
Outcome results
None listed