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Dilatation of the cervix is necessary before operative hysteroscopic procedures. This dilatation with Hegar dilators has certain difficulties and is associated with pain. Cervical priming with various substances soften the cervix, ease the entry for the operation and decrease complications such as uterine perforation.
The investigators aimed to compare rectally administered "misoprostol" and" hyoscine butyl bromide" with sham protocol.
The study is planned as a double blind randomised controlled one centre study. It will take part at a operative gynaecological department of a university hospital. Women who apply to the university clinic who have a medical indication for hysteroscopic surgery will be recruited after informed consent.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal misoprostol | Active Comparator | 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. |
|
| Rectal hyoscine butyl bromide | Active Comparator | 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. |
|
| Sham administration | No Intervention | A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Rectal administration 2 jours before the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Two hours after the procedure "postoperative 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. | Postoperative 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic administration | Need for analgesic administration | Postoperative 2 hours |
| Duration of procedure | Duration of cervical dilatation and total surgery |
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Inclusion Criteria:
Exclusion Criteria:
Hysteroscopy is an endoscopic surgery for the uterus
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| Name | Affiliation | Role |
|---|---|---|
| Serdar G Aydin | Bezmialem Üniversitesi Tıp Fakültesi Hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Istanbul | 34093 | Turkey (Türkiye) |
The results will be published
After the study is completed
The results will be published in a science citation indexed journal
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D002086 | Butylscopolammonium Bromide |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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Three group parallel design
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Double blind masking
| Hyoscine butyl bromide | Drug | Rectal administration 2 jours before the procedure |
|
|
| During the surgery |
| Ease of cervical dilatation | Ease of cervical dilatation will be evaluated using a 5 point likert scale.
| During the surgery |
| Initial cervical dilatation | Initial cervical dilatation will be evaluated using the Hegar dilatator number | During the surgery |
| D012816 | Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |