The Safety of Thermocautery Usage for Male Children's Circumcisions (MC)

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.

Study Overview

• Status: Completed
• Conditions: Circumcision, Male
• Intervention / Treatment: Device: Thermocautery

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.

• Study Type: Interventional
• Enrollment (Actual): 1780
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Thermocautery; Circumcision with thermocautery technique was applied all participants

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; Other Names: Study group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical processing time	Surgical processing times were analyzed retrospectively by using the hospital registry system	4-15 minutes

Collaborators and Investigators

• Sponsor: Kocatepe University
• Investigators: Principal Investigator: Ahmet Ali Tuncer, Asst Prof Dr, Afyon Kocatepe University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 8, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 8, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: circumcision; Thermocautery; Complication
• Other Study ID Numbers: 2011-KAEK-2 2017/2:52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No