Circumcision, MaleMCNCT03305523
The Safety of Thermocautery Usage for Male Children's Circumcisions
A study testing Thermocautery in people with Circumcision, Male, run by Kocatepe University.
Trial summary
Since circumcision is a significant workload for surgeons working at the rural state hospitals in Turkey, the use of circumcision techniques that are easy to implement and have low complications is becoming widespread. Read more about this study
- Who is it for?
- Ages 2 weeks to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Thermocautery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,780 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 1 May 2016
- 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 2 weeks to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients who circumcised by Thermocautery device Patients without additional disease between 2 weeks and 18 years included in the study Male gender
Who cannot join
- Other circumcision Techniques (Conventional surgical, Alis clamp, Tara, Mogen clamp...)
- Patients older than 18 years
- The presence of additional diseases ( such as hematologic disease, diabetes...)
- Patient with hypospadias
About this study
Since circumcision is a significant workload for surgeons working at the rural state hospitals in Turkey, the use of circumcision techniques that are easy to implement and have low complications is becoming widespread. This research will examine short and long-term complications of male circumcisions using thermocautery technique in light of current literature.
Read the detailed description
Patients who were circumcised between May 2014 and May 2016 at the Pediatric Surgery and Urology Clinics at Yuksekova State Hospital were retrospectively analyzed through the hospital registry system. Patients who underwent circumcision with thermocautery technique were examined in terms of age, duration of circumcision and complication rates. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term (late postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary phimosis, meatitis).
Patients were discharged after being kept under observation for 1 hour after circumcision. Patients were suggested to apply routine warm sitting bath, daily dressing and the patients with phimosis opening were suggested to apply epithelizing cream. On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were treated.
Statistical analysis: The data obtained from the study were transferred to a computer environment and evaluated with the help of Statistical Package for Social Sciences Version 19.0. Chi-square test was used to evaluate categorical data and Mann-Whitney U test was used to evaluate quantitative variables. P < 0.05 was considered statistically significant.
- Conditions
- Circumcision, Male
- Being tested
- Thermocautery
- Keywords
- circumcision; Thermocautery; Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermocauteryDevice
Also called Study group
In the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medical, Adana, Turkey) with 6 different temperature settings was used. Circumcision was performed in the same way as the surgical circumcision. Only cutting and bleeding intervention was done by using a thermocautery device. Cutting was performed by making the appropriate heat adjustment according to the age of the child and the thickness of the glans. Hemorrhage control was performed with a thermocautery device and then the skin-mucosa integrity was ensured by using a 5/0 absorbable suture
| Study group | Role | What they receive |
|---|---|---|
| Thermocautery | Experimental | Circumcision with thermocautery technique was applied all participants Receives: Device: Thermocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term complications (10 days- 2 years).
Measured: perioperative (during circumcision) - 6 months after circumcision
Secondary outcomes (1)
Surgical processing time
Surgical processing times were analyzed retrospectively by using the hospital registry system
Measured: 4-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start1 May 2014
- Primary completion1 May 2014
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumcision, MaleStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Short and long-term complications of male circumcisions using thermocautery was examined during 2 years period. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term (late postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary phimosis, meatitis).
- Masking
- None (open label)
- Enrolment
- 1,780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocatepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Ali Tuncer, Kocatepe University
- Investigators
- Ahmet Ali Tuncer, Asst Prof Dr, Principal investigator, Afyon Kocatepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305523
- Sponsor's protocol ID
- 2011-KAEK-2 2017/2:52
- Acronym
- MC
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Thermocautery Usage for Male Children's Circumcisions
- ClinicalTrials.gov ID
- NCT03305523
- Acronym / sponsor ID
- MC / 2011-KAEK-2 2017/2:52
- Conditions
- Circumcision, Male
- Keywords
- circumcision; Thermocautery; Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,780 participants (actual)
- Lead sponsor
- Kocatepe UniversityUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 10 Oct 2017 (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.
Since circumcision is a significant workload for surgeons working at the rural state hospitals in Turkey, the use of circumcision techniques that are easy to implement and have low complications is becoming widespread. This research will examine short and long-term complications of male circumcisions using thermocautery technique in light of current literature.
Detailed description
Patients who were circumcised between May 2014 and May 2016 at the Pediatric Surgery and Urology Clinics at Yuksekova State Hospital were retrospectively analyzed through the hospital registry system. Patients who underwent circumcision with thermocautery technique were examined in terms of age, duration of circumcision and complication rates. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term (late postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary phimosis, meatitis).
Patients were discharged after being kept under observation for 1 hour after circumcision. Patients were suggested to apply routine warm sitting bath, daily dressing and the patients with phimosis opening were suggested to apply epithelizing cream. On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were treated.
Statistical analysis: The data obtained from the study were transferred to a computer environment and evaluated with the help of Statistical Package for Social Sciences Version 19.0. Chi-square test was used to evaluate categorical data and Mann-Whitney U test was used to evaluate quantitative variables. P < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Short and long-term complications of male circumcisions using thermocautery was examined during 2 years period. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term (late postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary phimosis, meatitis).
| Arm | Type | Receives |
|---|---|---|
| Thermocautery | Experimental | Device: ThermocauteryCircumcision with thermocautery technique was applied all participants |
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who circumcised by Thermocautery device Patients without additional disease between 2 weeks and 18 years included in the study Male gender
Key exclusion criteria (4 listed)
- Other circumcision Techniques (Conventional surgical, Alis clamp, Tara, Mogen clamp...)
- Patients older than 18 years
- The presence of additional diseases ( such as hematologic disease, diabetes...)
- Patient with hypospadias
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 |
|---|---|---|
| ThermocauteryAlso: Study groupIn the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medical, Adana, Turkey) with 6 different temperature settings was used. Circumcision was performed in the same way as the surgical circumcision. Only cutting and bleeding intervention was done by using a thermocautery device. Cutting was performed by making the appropriate heat adjustment according to the age of the child and the thickness of the glans. Hemorrhage control was performed with a thermocautery device and then the skin-mucosa integrity was ensured by using a 5/0 absorbable suture | Device | Thermocautery |
Primary outcome
Complication rate
Time frame: perioperative (during circumcision) - 6 months after circumcision
On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term complications (10 days- 2 years).
1 secondary outcome
Surgical processing time
Time frame: 4-15 minutes
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 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Circumcision, Male
Not yet recruitingObservational study
Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
Active, not recruiting
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
Circumcision, Male
Not yet recruiting
Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision
Circumcision
Not yet recruitingPhase 2
Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
Posterior Urethral Valves
Recruiting
Compared Reversed US-Guided Dorsal Penile Nerve Block (RUSDPNB) With DPNB in Circumcisions for Pediatric Patients
Circumcision, Ultrasound
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 Ali Tuncer, Asst Prof Dr principal investigator
Afyon Kocatepe University
Questions about this trial
What is this clinical trial studying?
A study testing Thermocautery in people with Circumcision, Male, run by Kocatepe University.
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 4 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Complication rate (time frame: perioperative (during circumcision) - 6 months after circumcision). 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 Oct 2017.