EndometriumTenaculumNCT01506778
Tenaculum in Endometrial Sampling Procedure
A study testing Tenaculum in people with Endometrium and Biopsy, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a single tooth tenaculum to the cervix for steady the… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrium, Biopsy
- What is being tested?
- Tenaculum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2011to Dec 2011
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- The women has required endometrial sampling procedure in gynecology outpatients clinic.
- Who are capable understand the spoken words and describe the pain.
Who cannot join
- Stenotic cervical canal
- They had acute cervicitis
- Intense anxiety
- Need for coincident endocervical curettage
- Need for general anesthesia or local anesthetics
- The use of analgesic drug pre-procedure
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- Known history of malignancy
- Uterine anomalies or leiomyomas that distort the cervical canal and cavity
- A history of failed office endometrial sampling
- Positive β-HCG test.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Medicine
Adana, 01330
About this study
Official title: Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.
Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a single tooth tenaculum to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. However, grasping the cervix with a tenaculum can be a painful experience for the patient.A randomized controlled trial was conducted to evaluate using of tenaculum on pain perception of the patients and the procedure performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.
Read the detailed description
One hundred fifteen patients included for assessing pain perception and procedure performance during endometrial with pipelle. Patients were randomly assigned to one of two groups as Group 1( with tenaculum) and Group 2 (without tenaculum).
- Conditions
- Endometrium, Biopsy
- Being tested
- Tenaculum
- Keywords
- Endometrial Sampling Procedure, Likert Scala, Pipelle, Tenaculum, Visual Analog Pain Scala
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenaculumDevice
Single tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum.
| Study group | Role | What they receive |
|---|---|---|
| Group 1(With Tenaculum) | Active comparator | This group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure Receives: Device: Tenaculum |
| Group 2 (Without Tenaculum) | No intervention | This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scala for patient's pain perception
VAS performed four times each patient.
Measured: 5 second
Secondary outcomes (2)
Likert scala for procedure performance
Likert scaled one times by the physician.
Measured: 5 second
Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis.
Measured: 5-10 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriumStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ümran Küçükgöz Güleç, Cukurova University
- Investigators
- Ahmet Baris Guzel, Assist Prof Dr., Principal investigator, Cukurova University Faculty of Medicine Department of Obstetrics and GynecologyAybala Kubat, MD, Principal investigator, Şahinbey Goverment HospitalGhanim Khatib, MD, Principal investigator, Cukurova University Faculty of Medicine Department of Obstetrics and GynecologyFatma Tuncay Ozgunen, Prof Dr., Principal investigator, Cukurova University Faculty of Medicine Department of Obstetrics and GynecologyIbrahim Ferhat Urunsak, Assist Prof Dr., Principal investigator, Cukurova University Faculty of Medicine Department of Obstetrics and GynecologyUmran Kucukgoz Gulec, Assist Prof Dr., Study director, Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506778
- Sponsor's protocol ID
- CukurovaU
- Acronym
- Tenaculum
- Status last verified
- Jan 2012
- First submitted
- 2 Jan 2012
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Tenaculum Which is Actually Necessary for Endometrial Sampling Procedure by Pipelle.
- ClinicalTrials.gov ID
- NCT01506778
- Acronym / sponsor ID
- Tenaculum / CukurovaU
- Conditions
- Endometrium, Biopsy
- Keywords
- Endometrial Sampling Procedure, Likert Scala, Pipelle, Tenaculum, Visual Analog Pain Scala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jan 2012 (estimated)
- 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.
Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a single tooth tenaculum to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. However, grasping the cervix with a tenaculum can be a painful experience for the patient.A randomized controlled trial was conducted to evaluate using of tenaculum on pain perception of the patients and the procedure performance of the surgeons in endometrial sampling procedure(ESP) with pipelle.
Detailed description
One hundred fifteen patients included for assessing pain perception and procedure performance during endometrial with pipelle. Patients were randomly assigned to one of two groups as Group 1( with tenaculum) and Group 2 (without tenaculum).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(With Tenaculum) | Active comparator | Device: TenaculumThis group consisted of the patients whose had been applied tenaculum at cervix during the endometrial sampling procedure |
| Group 2 (Without Tenaculum) | No intervention | –This group consisted of the patients whose had been not applied tenaculum during the endometrial sampling procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 years old
- The women has required endometrial sampling procedure in gynecology outpatients clinic.
- Who are capable understand the spoken words and describe the pain.
Key exclusion criteria (10 listed)
- Stenotic cervical canal
- They had acute cervicitis
- Intense anxiety
- Need for coincident endocervical curettage
- Need for general anesthesia or local anesthetics
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 |
|---|---|---|
| TenaculumSingle tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum. | Device | Group 1(With Tenaculum) |
Primary outcome
Visual Analog Scala for patient's pain perception
Time frame: 5 second
VAS performed four times each patient.
2 secondary outcomes
Likert scala for procedure performance
Time frame: 5 second
Success rate as adequate sampling of endometrial tissue for histopathologic diagnosis.
Time frame: 5-10 day
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 10 Jan 2012.
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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.
Ahmet Baris Guzel, Assist Prof Dr. principal investigator
Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
Aybala Kubat, MD principal investigator
Şahinbey Goverment Hospital
Ghanim Khatib, MD principal investigator
Cukurova University Faculty of Medicine Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenaculum in people with Endometrium and Biopsy, run by Cukurova 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 3 inclusion and 10 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 10 Jan 2012. 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?
Visual Analog Scala for patient's pain perception (time frame: 5 second). 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 10 Jan 2012.