ClinicalTrials.gg
CompletedNCT03136224Updated May 2, 2017

Examination of Short and Long Term Complications of Thermocautery, Plastic Clamping and Surgical Circumcision Techniques

An interventional study of Thermocautery and Plastic Clamping in Circumcision, Male, sponsored by Kocatepe University. Completed. Open to male participants aged 1 Week to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-02.

Sponsored by Kocatepe University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled May 2014, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
2,062
Allocation
Non-randomized
Ages
1 Week to 18 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Circumcision, Male

Keywords

  • circumcision
  • Thermocautery
  • Clamp
  • Surgical Circumcision
03

In context

Lead sponsor

Kocatepe University is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Week to 18 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:Circumcised by Thermocautery, Alisklamp and surgical circumcision techniques

-

Exclusion Criteria: Other circumcision Techniques (Tara, Mogen clamp...) excluded

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,062 participants (actual)

Study arms

  • Experimental
    Thermocautery

    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

    Device: Thermocautery

  • Active comparator
    Plastic Clamping

    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

    Device: Plastic Clamping

  • Sham comparator
    Surgical Circumcision

    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.

    Device: Surgical Circumcision

Interventions

  • DeviceThermocautery

    Also known as: Experimental

  • DevicePlastic Clamping

    Also known as: Active comparator, Alisklamp

  • DeviceSurgical Circumcision

    Also known as: sham comparator

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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

    Time frame: May 2014 and May 2015 (circumcised in 1 year period)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2014 to primary completion in May 2014, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2017
First posted
May 2, 2017
StartActual
May 1, 2014
Primary completionActual
May 1, 2014
CompletionActual
May 1, 2015
Last update
May 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03136224
Lead sponsor
Kocatepe University
Responsible party
Ahmet Ali Tuncer (Asst Prof Dr, Kocatepe University) — Principal investigator
First posted
May 2, 2017
Start date
May 1, 2014
Primary completion
May 1, 2014
Completion
May 1, 2015
Last update
May 2, 2017

Study contacts

Ahmet Ali Tuncer, Asst Prof Dr
principal investigator · Afyon Kocatepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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