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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 .
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| misoprostol group | Active Comparator | 20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation. |
|
| vasopressin group | Active Comparator | 20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Yes: Eligibility is based on gender, As the subject of the study is hysterscopic myomectomy so the the clinical trial is based on female gender
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D014667 | Vasopressins |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| Vasopressin | Drug | 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. |
|
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 |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |