Hysteroscopic Surgery, Pain, Postoperative
Conditions
Keywords
misoprostol, hyoscine butyl bromide, cervical dilatation, cervical ripening, hysteroscopy, pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGMisoprostol
Rectal administration 2 jours before the procedure
Rectal administration 2 jours before the procedure
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind masking
Intervention model description
Three group parallel design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Reproductive aged women * Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae
Exclusion criteria
* Women who have undergone hysteroscopy previously * women who are in menopause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Postoperative 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic administration | Postoperative 2 hours | Need for analgesic administration |
| Duration of procedure | During the surgery | Duration of cervical dilatation and total surgery |
| Ease of cervical dilatation | During the surgery | Ease of cervical dilatation will be evaluated using a 5 point likert scale. 1. Very difficult 2. Difficult 3. Normal 4. Easy 5. Very easy |
| Initial cervical dilatation | During the surgery | Initial cervical dilatation will be evaluated using the Hegar dilatator number |
Countries
Turkey (Türkiye)
Outcome results
None listed