The Safety of Thermocautery Usage for Male Children's Circumcisions

Not Applicable

Completed

• Conditions: Circumcision, Male
• Interventions: Device: Thermocautery

• Registration Number: NCT03305523
• Lead Sponsor: Kocatepe University

Brief 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.

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 Timeline

• Study Start: 2014-05-01
• Primary Completion: 2014-05-01
• Study Completion: 2016-05-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-08
• Last Update Submitted: 2017-10-08
• Study First Posted: 2017-10-10
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1780

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermocautery	Thermocautery	Circumcision with thermocautery technique was applied all participants

Primary Outcome Measures

Name	Time	Method
Complication rate	perioperative (during circumcision) - 6 months after circumcision	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).

Secondary Outcome Measures

Name	Time	Method
Surgical processing time	4-15 minutes	Surgical processing times were analyzed retrospectively by using the hospital registry system