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Completed

NCT Number: NCT03359655

A Trial for Peroperative Procedure and 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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Rectal administration 2 jours before the procedure

Other names: Cytotec

hyoscine butyl bromide

Drug

Rectal administration 2 jours before the procedure

Other names: Buscopan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Analgesic administration

    Time frame: Postoperative 2 hours

    Need for analgesic administration

  2. Duration of procedure

    Time frame: During the surgery

    Duration of cervical dilatation and total surgery

  3. Ease of cervical dilatation

    Time frame: During the surgery

    Ease of cervical dilatation will be evaluated using a 5 point likert scale.

    • Very difficult
    • Difficult
    • Normal
    • Easy
    • Very easy
  4. Initial cervical dilatation

    Time frame: During the surgery

    Initial cervical dilatation will be evaluated using the Hegar dilatator number

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
Dec 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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