Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
|ClinicalTrials.gov Identifier: NCT03930069|
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Information provided by (Responsible Party):
Hossam mohamed, Zagazig University
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 .
|Condition or disease||Intervention/treatment||Phase|
|Submucous Leiomyoma of Uterus||Drug: Misoprostol Drug: Vasopressin||Phase 2 Phase 3|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.|
|Actual Study Start Date :||May 2, 2016|
|Actual Primary Completion Date :||January 30, 2017|
|Actual Study Completion Date :||March 15, 2017|
Active Comparator: misoprostol group
20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.
prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy
Other Name: Misotac
Active Comparator: vasopressin group
20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy
one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe.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.
Primary Outcome Measures :
- intraoperative bleeding [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 hours before myomectomy and 24 hour after myomectomy ]haemoglobin and hematocrit values before and after myomectomy
Secondary Outcome Measures :
- Degree of visual clarity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: start from grasping the cervix till insertion of hysterescope ]time needed to dilate the cervix to admit the operative hysterescope
No Contacts or Locations Provided