ClinicalTrials.gg
CompletedNCT03305523MCUpdated Oct 10, 2017

The Safety of Thermocautery Usage for Male Children's Circumcisions

An interventional study of Thermocautery in Circumcision, Male, sponsored by Kocatepe University. Completed. Open to male participants aged 2 Weeks to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-10.

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

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled May 2014, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
1,780
Allocation
Not applicable
Ages
2 Weeks 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. 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.

02

Conditions studied

  • Circumcision, Male

Keywords

  • circumcision; Thermocautery; Complication
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
2 Weeks to 18 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients who circumcised by Thermocautery device Patients without additional disease between 2 weeks and 18 years included in the study Male gender

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,780 participants (actual)

Study arms

  • Experimental
    Thermocautery

    Circumcision with thermocautery technique was applied all participants

    Device: Thermocautery

Interventions

  • DeviceThermocautery

    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

    Also known as: Study group

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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

    Time frame: 4-15 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

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
Oct 4, 2017
First posted
Oct 10, 2017
StartActual
May 1, 2014
Primary completionActual
May 1, 2014
CompletionActual
May 1, 2016
Last update
Oct 10, 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 Oct 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03305523
Lead sponsor
Kocatepe University
Responsible party
Ahmet Ali Tuncer (Asst Prof Dr, Kocatepe University) — Principal investigator
First posted
Oct 10, 2017
Start date
May 1, 2014
Primary completion
May 1, 2014
Completion
May 1, 2016
Last update
Oct 10, 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 Oct 2017. You cannot join it, but the record below documents what was studied.

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