A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
NCT ID: NCT03359655
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2018-06-11
2018-12-13
Brief Summary
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The investigators aimed to compare rectally administered "misoprostol" and" hyoscine butyl bromide" with sham protocol.
Detailed Description
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Patients included in the study will be allocated to three groups. The intervention arms will be two arms and one sham group. The randomisation will be performed to three groups by a third party who is not involved in the surgical procedures.
Upon initial evaluation, a form evaluating age and other sociodemographic characteristics will be filled out before the scheduled hysteroscopy procedure. After completion of the initial form, rectal tablets will be administered according to the allocated group; two hours previously to the procedure. Hysteroscopy will be under general anaesthesia with a 10 mm hysteroscope during the follicular phase of the menstrual cycle.
During the procedure the duration of the cervical entry and total duration of the operation will be noted. Additionally basal dilatation will be noted.
Two hours after the procedure pain will be documented according to the Visual Analogue Scale which is a ten point scale. A value of "1" indicates "no pain". A value of "10" indicates "excruciating" pain.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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Rectal misoprostol
200 mcg of misoprostol will be administered rectally- 2 hours previously. This intervention will be performed by a third party health professional who will be blinded to the procedure.
Misoprostol
Rectal administration 2 jours before the procedure
Rectal hyoscine butyl bromide
10 mg hyoscine butyl bromide administered rectally- 2 hours previously. This intervention will be performed by a third party health professional who will be blinded to the procedure.
Hyoscine butyl bromide
Rectal administration 2 jours before the procedure
Sham administration
A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered
No interventions assigned to this group
Interventions
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Misoprostol
Rectal administration 2 jours before the procedure
Hyoscine butyl bromide
Rectal administration 2 jours before the procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae
Exclusion Criteria
* women who are in menopause
18 Years
55 Years
FEMALE
Yes
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Principal Investigators
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Serdar G Aydin
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
Locations
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Bezmialem Vakif University
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2017-6-
Identifier Type: -
Identifier Source: org_study_id