Postoperative PainPhase 4NCT01909765
Two Different Surgical Techniques on Postoperative Circumcision Pain
A Phase 4 study testing Dorsal slit and Double incision in people with Postoperative Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain. Read more about this study
- Who is it for?
- Ages 2 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dorsal slit and Double incision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2013to Aug 2013
- Phase
- Phase 4
- 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 2 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Children
Who cannot join
- Patients with any bleeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Education and Research Hospital
Ankara, 06610
Reyhan Polat, MD, +905326734310, reyhanp9@gmail.com
Reyhan Polat, MD
About this study
Official title: Comparison of Two Different Circumcision Surgical Technique on Postoperative Pain
To compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain.
Read the detailed description
Two different circumcision techniques result in different kinds of pain.This research aims determine which is more beneficial to the patient.
- Conditions
- Postoperative Pain
- Being tested
- Dorsal slit, Double incision
- Keywords
- Circumcision, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal slitOther
Skin and mucosa incision made together
Double incisionOther
Also called Surgical technique
Skin and mucosa incision made separately
| Study group | Role | What they receive |
|---|---|---|
| Dorsal slite | Active comparator | Skin and mucosa insicion made together Receives: Other: Dorsal slit |
| Double incision | Experimental | Skin and mucosa incision made separately Receives: Other: Double incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses postoperative pain scores on Modified Objective Assessment Scale (MOAS)
Measured: Postoperative first two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
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 Postoperative PainStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Reyhan Polat, MD, Principal investigator, Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909765
- Sponsor's protocol ID
- Circumcicsion
- Status last verified
- Jul 2013
- First submitted
- 18 Jul 2013
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Karakoyunlu N, Polat R, Aydin GB, Ergil J, Akkaya T, Ersoy H. Effect of two surgical circumcision procedures on postoperative pain: A prospective, randomized, double-blind study. J Pediatr Urol. 2015 Jun;11(3):124.e1-5. doi: 10.1016/j.jpurol.2015.01.002. Epub 2015 Mar 3.
PubMed 25842991
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Circumcision Surgical Technique on Postoperative Pain
- ClinicalTrials.gov ID
- NCT01909765
- Acronym / sponsor ID
- Circumcicsion
- Conditions
- Postoperative Pain
- Keywords
- Circumcision, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 29 Jul 2013 (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.
To compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain.
Detailed description
Two different circumcision techniques result in different kinds of pain.This research aims determine which is more beneficial to the patient.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal slite | Active comparator | Other: Dorsal slitSkin and mucosa insicion made together |
| Double incision | Experimental | Other: Double incisionSkin and mucosa incision made separately |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children
Key exclusion criteria (1 listed)
- Patients with any bleeding
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 |
|---|---|---|
| Dorsal slitSkin and mucosa incision made together | Other | Dorsal slite |
| Double incisionAlso: Surgical techniqueSkin and mucosa incision made separately | Other | Double incision |
Primary outcome
To asses postoperative pain scores on Modified Objective Assessment Scale (MOAS)
Time frame: Postoperative first two hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
- Derived from this study: PubMed 25842991Karakoyunlu N, Polat R, Aydin GB, Ergil J, Akkaya T, Ersoy H. Effect of two surgical circumcision procedures on postoperative pain: A prospective, randomized, double-blind study. J Pediatr Urol. 2015 Jun;11(3):124.e1-5. doi: 10.1016/j.jpurol.2015.01.002. Epub 2015 Mar 3.
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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.
Diskapi Yildirim Beyazit Education and Research Hospital
Ankara, Turkey (Türkiye)
Reyhan Polat, MD principal investigator
Yildirim Beyazit Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dorsal slit and Double incision in people with Postoperative Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses postoperative pain scores on Modified Objective Assessment Scale (MOAS) (time frame: Postoperative first two hours). 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 NCT01909765, 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 29 Jul 2013.