The Safety of Thermocautery Usage for Male Children's Circumcisions

Circumcision, Male Clinical Trial

— MC  

Official title:

The Safety of Thermocautery Usage for Male Children's Circumcisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305523
• Other study ID #: 2011-KAEK-2 2017/2:52
• Status: Completed
• Phase: N/A
• First received: October 4, 2017
• Last updated: October 8, 2017
• Start date: May 1, 2014
• Est. completion date: May 1, 2016

Study information

• Verified date: October 2017
• Source: Kocatepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This research will examine short and long-term complications of male circumcisions using thermocautery technique in light of current literature.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1780
• Est. completion date: May 1, 2016
• Est. primary completion date: May 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 18 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Circumcision, Male

Intervention

Device:
• Thermocautery
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kocatepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	perioperative (during circumcision) - 6 months after circumcision
Secondary	Surgical processing time	Surgical processing times were analyzed retrospectively by using the hospital registry system	4-15 minutes