search
Back to results

A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration

Primary Purpose

Hysteroscopic Surgery, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Misoprostol
Hyoscine butyl bromide
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hysteroscopic Surgery focused on measuring misoprostol, hyoscine butyl bromide, cervical dilatation, cervical ripening, hysteroscopy, pain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Rectal misoprostol

Rectal hyoscine butyl bromide

Sham administration

Arm Description

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.

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.

A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analgesic administration
Need for analgesic administration
Duration of procedure
Duration of cervical dilatation and total 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
Initial cervical dilatation
Initial cervical dilatation will be evaluated using the Hegar dilatator number

Full Information

First Posted
November 7, 2017
Last Updated
December 24, 2018
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT03359655
Brief Title
A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
Official Title
A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
December 4, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopic Surgery, Pain, Postoperative
Keywords
misoprostol, hyoscine butyl bromide, cervical dilatation, cervical ripening, hysteroscopy, pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three group parallel design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind masking
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rectal misoprostol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rectal hyoscine butyl bromide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham administration
Arm Type
No Intervention
Arm Description
A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Description
Rectal administration 2 jours before the procedure
Intervention Type
Drug
Intervention Name(s)
Hyoscine butyl bromide
Other Intervention Name(s)
Buscopan
Intervention Description
Rectal administration 2 jours before the procedure
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
Postoperative 2 hours
Secondary Outcome Measure Information:
Title
Analgesic administration
Description
Need for analgesic administration
Time Frame
Postoperative 2 hours
Title
Duration of procedure
Description
Duration of cervical dilatation and total surgery
Time Frame
During the surgery
Title
Ease of cervical dilatation
Description
Ease of cervical dilatation will be evaluated using a 5 point likert scale. Very difficult Difficult Normal Easy Very easy
Time Frame
During the surgery
Title
Initial cervical dilatation
Description
Initial cervical dilatation will be evaluated using the Hegar dilatator number
Time Frame
During the surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Hysteroscopy is an endoscopic surgery for the uterus
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar G Aydin
Organizational Affiliation
Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be published
IPD Sharing Time Frame
After the study is completed
IPD Sharing Access Criteria
The results will be published in a science citation indexed journal

Learn more about this trial

A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration

We'll reach out to this number within 24 hrs