Hysteroscopic SurgeryNCT03359655
A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
A study testing Misoprostol and Hyoscine butyl bromide in people with Hysteroscopic Surgery and Pain, Postoperative, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopic Surgery, Pain, Postoperative
- What is being tested?
- Misoprostol and Hyoscine butyl bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2018to 13 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reproductive aged women
- Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae
Who cannot join
- Women who have undergone hysteroscopy previously
- women who are in menopause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
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.
Read the 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.
- Conditions
- Hysteroscopic Surgery, Pain, Postoperative
- Being tested
- Misoprostol, Hyoscine butyl bromide
- Keywords
- misoprostol, hyoscine butyl bromide, cervical dilatation, cervical ripening, hysteroscopy, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Rectal administration 2 jours before the procedure
Hyoscine butyl bromideDrug
Also called Buscopan
Rectal administration 2 jours before the procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Misoprostol |
| 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. Receives: Drug: Hyoscine butyl bromide |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 2 hours
Secondary outcomes (4)
Analgesic administration
Need for analgesic administration
Measured: Postoperative 2 hours
Duration of procedure
Duration of cervical dilatation and total surgery
Measured: During the surgery
Ease of cervical dilatation
Ease of cervical dilatation will be evaluated using a 5 point likert scale.
- Very difficult
- Difficult
- Normal
- Easy
- Very easy
Measured: During the surgery
Initial cervical dilatation
Initial cervical dilatation will be evaluated using the Hegar dilatator number
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start11 Jun 2018
- Primary completion4 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysteroscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three group parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serdar G Aydin, Principal investigator, Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359655
- Sponsor's protocol ID
- 2017-6-
- Status last verified
- Dec 2018
- First submitted
- 7 Nov 2017
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be published
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
- ClinicalTrials.gov ID
- NCT03359655
- Acronym / sponsor ID
- 2017-6-
- Conditions
- Hysteroscopic Surgery, Pain, Postoperative
- Keywords
- misoprostol, hyoscine butyl bromide, cervical dilatation, cervical ripening, hysteroscopy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three group parallel design
| Arm | Type | Receives |
|---|---|---|
| Rectal misoprostol | Active comparator | Drug: Misoprostol200 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 | Drug: Hyoscine butyl bromide10 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Reproductive aged women
- Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae
Key exclusion criteria (2 listed)
- Women who have undergone hysteroscopy previously
- women who are in menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: CytotecRectal administration 2 jours before the procedure | Drug | Rectal misoprostol |
| Hyoscine butyl bromideAlso: BuscopanRectal administration 2 jours before the procedure | Drug | Rectal hyoscine butyl bromide |
Primary outcome
Postoperative pain
Time frame: 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.
4 secondary outcomes
Analgesic administration
Time frame: Postoperative 2 hours
Duration of procedure
Time frame: During the surgery
Ease of cervical dilatation
Time frame: During the surgery
Initial cervical dilatation
Time frame: During the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Individual participant dataSharing planned: Yes. The results will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serdar G Aydin principal investigator
Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Hyoscine butyl bromide in people with Hysteroscopic Surgery and Pain, Postoperative, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Postoperative 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.