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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT03136224
Study groupRoleWhat they receive
ThermocauteryExperimentalIn 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 ClampingActive comparatorAlisklamp (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 CircumcisionSham comparatorIn 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.

  1. 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)
  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.

  1. First posted2 May 2017
  2. Study start1 May 2014
  3. Primary completion1 May 2014
  4. Study completion1 May 2015

Resources

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)
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

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.

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