Office HysteroscopyNCT05246436
Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy
A study testing warming saline media and room temperature saline media in people with Office Hysteroscopy, run by Amira Mohamed at 1 site in Egypt.
Trial summary
The aim of study is to determine if the use of warm saline distention media during outpatient hysteroscopy reduces Pain/discomfort of the procedure. Research hypothesis: In women undergoing office hysteroscopy, there will be reduced pain perception when using warm saline (body temperature 37°C during office… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Office Hysteroscopy
- What is being tested?
- warming saline media and room temperature saline media
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 30 Dec 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥ 18 years old.
- Indications of diagnostic hysteroscopy: Cases complaining of abnormal uterine bleeding and /or undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal Ostia for infertility, removal of foreign body, Suspected Mullerian anomalies.
Who cannot join
- - Contra-indications of diagnostic hysteroscopy: unable to exclude pregnancy, acute pelvic infection, active genital herpes, confirmed cervical or endometrial cancer and profuse bleeding at the time of the procedure.
- Any usage of analgesic agent on the day of the procedure.
- Failure of entry of the cervical canal requiring cervical dilatation.
- Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis.
- Patient refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy: Randomized Controlled Trial.
The aim of study is to determine if the use of warm saline distention media during outpatient hysteroscopy reduces Pain/discomfort of the procedure.
Research hypothesis: In women undergoing office hysteroscopy, there will be reduced pain perception when using warm saline (body temperature 37°C during office hysteroscopy.
Research question: In women undergoing office hysteroscopy, Will there be a difference in pain perceived during the procedure if the investigators use warm saline(body temperature 37°C) rather than normal saline (room temperature) as a distension media?
Read the detailed description
Office hysteroscopy is a procedure where a doctor uses a thin tube with a tiny camera to look inside the uterus. There are no incisions. Saline solution is used to expand the uterus in order to look at the inside of the uterus .
The vaginoscopic 'non-touch' technique first described by Bettocchi and Selvaggi (1997) has avoided the need for using a speculum and tenaculum in outpatient hysteroscopy; miniaturization of fibreoptic instruments has also enabled the procedure to be conducted without intra- or paracervical anesthesia.
Indications for diagnostic \& therapeutic outpatient hysteroscopy include abnormal uterine bleeding, reproductive problems, glandular abnormalities on cervical smear, identification and retrieval of lost intrauterine devices, polypectomy, endometrial ablation and myomectomy.
Hysteroscopic procedures can be successfully performed in an office setting without any anesthesia.
There are pharmacological and non pharmacological analgesic methods. Non pharmacological methods, such as vaginoscopy or mini hysteroscopes, are advisable to avoid producing pain . The pharmacological method including intervention method which is para cervical block, reducing pain during and 30 minutes after hysteroscopy. And medical methods such as Non steroidal anti-inflammatory drugs (NSAIDs) seem to be useful in the postoperative period. Evidence is not clear about combination of techniques or misoprostol .
Endometrial cavity is an empty cavity and requires distension to permit visualization. Therefore, during hysteroscopy either fluid or carbon dioxide gas is used to enlarge the endometrial cavity. To achieve a panoramic view, the uterine walls must be forcibly separated. The thick muscle of uterine walls needs a minimum pressure of 40 mm Hg to distend the cavity adequately for hysteroscopic visualization.
Normal saline is usually recommended as the distention medium in outpatient hysteroscopy as it allows improved image resolution and is associated with less vasovagal episodes compared with carbon dioxide. Although it is thought that uterine contractility could be provoked by instillation of saline at lower temperatures, there is little data on the effect of temperature on clarity of image, discomfort/pain, outcome of the procedure and patient satisfaction.
- Conditions
- Office Hysteroscopy
- Being tested
- warming saline media, room temperature saline media
- Keywords
- warm saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warming saline mediaProcedure or surgery
use warm saline as a distention media in office hysteroscopy
room temperature saline mediaProcedure or surgery
use room temperature saline as a distention media in office hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| warm saline | Active comparator | Patients who used warm saline as a distention media in office hysteroscopy Receives: Procedure: warming saline media |
| room temperature saline | Sham comparator | Patients who used room temprature saline as a distention media in office hysteroscopy Receives: Procedure: room temperature saline media |
What is being measured
The primary outcome is the main question the study is designed to answer.
warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS)
The patient makes a mark on the visual analog scale line to indicate the intensity of her pain. Pain will be measured using a 10-cm visual analogue scale (VAS) graded from 0 to 10 , (0) means no pain (better outcome), and (10) means worst possible pain (worse outcome)
Measured: base line
Secondary outcomes (1)
The clarity of the view.(questionnaire).
questionnaire including clear (better outcome) or dim (worse out come)
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Apr 2021
- Primary completion30 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Office HysteroscopyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amira Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246436
- Sponsor's protocol ID
- FMASU MS 567/2021
- Status last verified
- Feb 2022
- First submitted
- 12 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Issat T, Beta J, Nowicka MA, Durczynski A, Jakimiuk AJ. Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Clin Exp Obstet Gynecol. 2017;44(3):359-363.
PubMed 29949273
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Warm Fluid Distension Media in Relieving Pain in Outpatient Hysteroscopy: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05246436
- Acronym / sponsor ID
- FMASU MS 567/2021
- Conditions
- Office Hysteroscopy
- Keywords
- warm saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amira MohamedUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 18 Feb 2022 (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.
The aim of study is to determine if the use of warm saline distention media during outpatient hysteroscopy reduces Pain/discomfort of the procedure.
Research hypothesis: In women undergoing office hysteroscopy, there will be reduced pain perception when using warm saline (body temperature 37°C during office hysteroscopy.
Research question: In women undergoing office hysteroscopy, Will there be a difference in pain perceived during the procedure if the investigators use warm saline(body temperature 37°C) rather than normal saline (room temperature) as a distension media?
Detailed description
Office hysteroscopy is a procedure where a doctor uses a thin tube with a tiny camera to look inside the uterus. There are no incisions. Saline solution is used to expand the uterus in order to look at the inside of the uterus .
The vaginoscopic 'non-touch' technique first described by Bettocchi and Selvaggi (1997) has avoided the need for using a speculum and tenaculum in outpatient hysteroscopy; miniaturization of fibreoptic instruments has also enabled the procedure to be conducted without intra- or paracervical anesthesia.
Indications for diagnostic \& therapeutic outpatient hysteroscopy include abnormal uterine bleeding, reproductive problems, glandular abnormalities on cervical smear, identification and retrieval of lost intrauterine devices, polypectomy, endometrial ablation and myomectomy.
Hysteroscopic procedures can be successfully performed in an office setting without any anesthesia.
There are pharmacological and non pharmacological analgesic methods. Non pharmacological methods, such as vaginoscopy or mini hysteroscopes, are advisable to avoid producing pain . The pharmacological method including intervention method which is para cervical block, reducing pain during and 30 minutes after hysteroscopy. And medical methods such as Non steroidal anti-inflammatory drugs (NSAIDs) seem to be useful in the postoperative period. Evidence is not clear about combination of techniques or misoprostol .
Endometrial cavity is an empty cavity and requires distension to permit visualization. Therefore, during hysteroscopy either fluid or carbon dioxide gas is used to enlarge the endometrial cavity. To achieve a panoramic view, the uterine walls must be forcibly separated. The thick muscle of uterine walls needs a minimum pressure of 40 mm Hg to distend the cavity adequately for hysteroscopic visualization.
Normal saline is usually recommended as the distention medium in outpatient hysteroscopy as it allows improved image resolution and is associated with less vasovagal episodes compared with carbon dioxide. Although it is thought that uterine contractility could be provoked by instillation of saline at lower temperatures, there is little data on the effect of temperature on clarity of image, discomfort/pain, outcome of the procedure and patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warm saline | Active comparator | Procedure: warming saline mediaPatients who used warm saline as a distention media in office hysteroscopy |
| room temperature saline | Sham comparator | Procedure: room temperature saline mediaPatients who used room temprature saline as a distention media in office hysteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Age ≥ 18 years old.
- Indications of diagnostic hysteroscopy: Cases complaining of abnormal uterine bleeding and /or undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal Ostia for infertility, removal of foreign body, Suspected Mullerian anomalies.
Key exclusion criteria (5 listed)
- - Contra-indications of diagnostic hysteroscopy: unable to exclude pregnancy, acute pelvic infection, active genital herpes, confirmed cervical or endometrial cancer and profuse bleeding at the time of the procedure.
- Any usage of analgesic agent on the day of the procedure.
- Failure of entry of the cervical canal requiring cervical dilatation.
- Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis.
- Patient refusal to participate in the study.
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 |
|---|---|---|
| warming saline mediause warm saline as a distention media in office hysteroscopy | Procedure or surgery | warm saline |
| room temperature saline mediause room temperature saline as a distention media in office hysteroscopy | Procedure or surgery | room temperature saline |
Primary outcome
warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS)
Time frame: base line
The patient makes a mark on the visual analog scale line to indicate the intensity of her pain. Pain will be measured using a 10-cm visual analogue scale (VAS) graded from 0 to 10 , (0) means no pain (better outcome), and (10) means worst possible pain (worse outcome)
1 secondary outcome
The clarity of the view.(questionnaire).
Time frame: base line
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 18 Feb 2022.
- Background: PubMed 29949273Issat T, Beta J, Nowicka MA, Durczynski A, Jakimiuk AJ. Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Clin Exp Obstet Gynecol. 2017;44(3):359-363.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warming saline media and room temperature saline media in people with Office Hysteroscopy, run by Amira Mohamed at 1 site in Egypt.
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 5 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 18 Feb 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS) (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246436, which also lists 1 linked publication.
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 18 Feb 2022.