Circumcision, MaleNCT03136224
Examination of Short and Long Term Complications of Thermocautery, Plastic Clamping and Surgical Circumcision Techniques
A study testing Thermocautery, Plastic Clamping and Surgical Circumcision 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 1 week to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Thermocautery, Plastic Clamping and Surgical Circumcision
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,062 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 1 May 2015
- 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 1 week to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria:Circumcised by Thermocautery, Alisklamp and surgical circumcision techniques
-
Exclusion Criteria: Other circumcision Techniques (Tara, Mogen clamp...) excluded
About this study
Official title: Comparison of Short and Long Term Complications According to the Circumcision Technique Applied During the Childhood
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. In this study, thermocautery, plastic clamping, and conventional (open surgical) circumcision techniques were compared to each other in terms of their short and long term complications.
Read the detailed description
The study was carried out in accordance with the Helsinki declaration rules, with the approval of the local ethics committee. Male patients who applied to Hakkari State Hospital and Yüksekova State Hospital pediatric surgery clinics between May 2014 and May 2015 for the circumcision operation were analyzed retrospectively by using the hospital registry system. Patients were evaluated in terms of age groups, accompanying pathologies, anesthesia techniques, duration of the surgery, complication rates, and circumcision techniques. Data obtained from the study were transferred to a computer environment and assessed 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. The distribution of the data was tested by using one of the normality tests such as Shapiro-Wilk test in case of the comparison of surgical time. Kruskal Wallis test was used for nonparametric tests in group comparisons when data were not normally distributed. The Dunn test was used as a post-hoc test when different groups were determined. P <0.05 was considered statistically significant.
Circumcision was performed by a pediatric surgeon and an assistant health professional under sterile conditions in the operating room or circumcision room.
Penile block and local infiltration anesthesia (penile ring block, penile dorsal nerve block) were performed to all other patients with Bupivacaine, and Prilocaine. Open surgery, thermocautery, and plastic clamp (Alisklamp) methods were used as circumcision techniques.
In classical surgical circumcision, foreskin was hung up with the clamp. The outer skin and secondly the mucosa was cut by using scissors. Following the hemorrhage intervention, the skin-mucosa integrity was ensured by using the 5/0 absorbable suture. Medical dressing was done.
Alisklamp was used in the plastic clamp technique. The clamp size was chosen according to the diameter of the penis of the patient. The clamp was inserted into the glans and then the skin and the mucosa were pulled to the appropriate size and clamped. The skin and mucosa were excised from the distal part of the clamp with the aid of a lancet. After the operation, the clamp was removed on the 4th day.
In the thermocautery method, a digital thermocautery device 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.
Routine warm sitting pool and daily medical dressing were recommended after circumcision. Furthermore, it was recommended to patients with phimosis to apply epithelium cicatrising cream. On the 10th postoperative day, all patients were recruited for routine control. Patients with complications were followed up for a long term. Complications were treated.
- Conditions
- Circumcision, Male
- Being tested
- Thermocautery, Plastic Clamping, Surgical Circumcision
- Keywords
- circumcision, Thermocautery, Clamp, Surgical Circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermocauteryDevice
Also called Experimental
Plastic ClampingDevice
Also called Active comparator, Alisklamp
Surgical CircumcisionDevice
Also called sham comparator
| Study group | Role | What they receive |
|---|---|---|
| Thermocautery | Experimental | In the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medikal, 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 Receives: Device: Thermocautery |
| Plastic Clamping | Active comparator | Alisklamp (Alisklamp, Abagrup Health Services Ltd, Ankara, Turkey) was used in the plastic clamp technique. The clamp size was chosen according to the diameter of the penis of the patient. The clamp was inserted into the glans and then the skin and the mucosa were pulled to the appropriate size and clamped. The skin and mucosa were excised from the distal part of the clamp with the aid of a lancet. After the operation, the clamp was removed on the 4th day Receives: Device: Plastic Clamping |
| Surgical Circumcision | Sham comparator | In classical surgical circumcision, foreskin was hung up with the clamp. The outer skin and secondly the mucosa was cut by using scissors. Following the hemorrhage intervention, the skin-mucosa integrity was sutured by using the 5/0 absorbable suture. Medical dressing was done. Receives: Device: Surgical Circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
The diversity in circumcision techniques is because of the search for a more practical, cheaper, safer, and less complicated technique. In this study, complications of circumcisions performed by pediatric surgeon specialists by using three different techniques (thermocautery, alisklamp, and surgical circumcision) in two different hospitals in Turkey were investigated retrospectively.
Measured: May 2014 and May 2015 (circumcised in 1 year period)
Secondary outcomes (1)
Surgical processing time
Surgical processing time of groups were analyzed retrospectively by using the hospital registry system
Measured: May 2014 and May 2015 (circumcised in 1 year period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 May 2014
- Primary completion1 May 2014
- Study completion1 May 2015
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Thermocautery group Plastic clamping group Classic (Surgical) circumcision group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,062 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
- NCT03136224
- Sponsor's protocol ID
- 2011-KAEK-2. 2016/3:35
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short and Long Term Complications According to the Circumcision Technique Applied During the Childhood
- ClinicalTrials.gov ID
- NCT03136224
- Acronym / sponsor ID
- 2011-KAEK-2. 2016/3:35
- Conditions
- Circumcision, Male
- Keywords
- circumcision, Thermocautery, Clamp, Surgical Circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,062 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 2015 (actual)
- First posted
- 2 May 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. In this study, thermocautery, plastic clamping, and conventional (open surgical) circumcision techniques were compared to each other in terms of their short and long term complications.
Detailed description
The study was carried out in accordance with the Helsinki declaration rules, with the approval of the local ethics committee. Male patients who applied to Hakkari State Hospital and Yüksekova State Hospital pediatric surgery clinics between May 2014 and May 2015 for the circumcision operation were analyzed retrospectively by using the hospital registry system. Patients were evaluated in terms of age groups, accompanying pathologies, anesthesia techniques, duration of the surgery, complication rates, and circumcision techniques. Data obtained from the study were transferred to a computer environment and assessed 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. The distribution of the data was tested by using one of the normality tests such as Shapiro-Wilk test in case of the comparison of surgical time. Kruskal Wallis test was used for nonparametric tests in group comparisons when data were not normally distributed. The Dunn test was used as a post-hoc test when different groups were determined. P <0.05 was considered statistically significant.
Circumcision was performed by a pediatric surgeon and an assistant health professional under sterile conditions in the operating room or circumcision room.
Penile block and local infiltration anesthesia (penile ring block, penile dorsal nerve block) were performed to all other patients with Bupivacaine, and Prilocaine. Open surgery, thermocautery, and plastic clamp (Alisklamp) methods were used as circumcision techniques.
In classical surgical circumcision, foreskin was hung up with the clamp. The outer skin and secondly the mucosa was cut by using scissors. Following the hemorrhage intervention, the skin-mucosa integrity was ensured by using the 5/0 absorbable suture. Medical dressing was done.
Alisklamp was used in the plastic clamp technique. The clamp size was chosen according to the diameter of the penis of the patient. The clamp was inserted into the glans and then the skin and the mucosa were pulled to the appropriate size and clamped. The skin and mucosa were excised from the distal part of the clamp with the aid of a lancet. After the operation, the clamp was removed on the 4th day.
In the thermocautery method, a digital thermocautery device 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.
Routine warm sitting pool and daily medical dressing were recommended after circumcision. Furthermore, it was recommended to patients with phimosis to apply epithelium cicatrising cream. On the 10th postoperative day, all patients were recruited for routine control. Patients with complications were followed up for a long term. Complications were treated.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Thermocautery group Plastic clamping group Classic (Surgical) circumcision group
| Arm | Type | Receives |
|---|---|---|
| Thermocautery | Experimental | Device: ThermocauteryIn the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medikal, 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 |
| Plastic Clamping | Active comparator | Device: Plastic ClampingAlisklamp (Alisklamp, Abagrup Health Services Ltd, Ankara, Turkey) was used in the plastic clamp technique. The clamp size was chosen according to the diameter of the penis of the patient. The clamp was inserted into the glans and then the skin and the mucosa were pulled to the appropriate size and clamped. The skin and mucosa were excised from the distal part of the clamp with the aid of a lancet. After the operation, the clamp was removed on the 4th day |
| Surgical Circumcision | Sham comparator | Device: Surgical CircumcisionIn classical surgical circumcision, foreskin was hung up with the clamp. The outer skin and secondly the mucosa was cut by using scissors. Following the hemorrhage intervention, the skin-mucosa integrity was sutured by using the 5/0 absorbable suture. Medical dressing was done. |
Who may qualify
- Ages
- 1 week to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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: Experimental | Device | Thermocautery |
| Plastic ClampingAlso: Active comparator, Alisklamp | Device | Plastic Clamping |
| Surgical CircumcisionAlso: sham comparator | Device | Surgical Circumcision |
Primary outcome
Complication rate
Time frame: May 2014 and May 2015 (circumcised in 1 year period)
The diversity in circumcision techniques is because of the search for a more practical, cheaper, safer, and less complicated technique. In this study, complications of circumcisions performed by pediatric surgeon specialists by using three different techniques (thermocautery, alisklamp, and surgical circumcision) in two different hospitals in Turkey were investigated retrospectively.
1 secondary outcome
Surgical processing time
Time frame: May 2014 and May 2015 (circumcised in 1 year period)
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 2 May 2017.
- Individual participant dataSharing planned: Yes
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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 Ali Tuncer, Asst Prof Dr principal investigator
Afyon Kocatepe University
Questions about this trial
What is this clinical trial studying?
A study testing Thermocautery, Plastic Clamping and Surgical Circumcision 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?
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 2 May 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. 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?
Complication rate (time frame: May 2014 and May 2015 (circumcised in 1 year period)). 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 2 May 2017.