Clinical trial NCT03305523: The Safety of Thermocautery Usage for Male Children's Circumcisions
Official title: The Safety of Thermocautery Usage for Male Children's Circumcisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision, Male
Keywords: circumcision; Thermocautery; Complication
Lead sponsor: Kocatepe University
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 1780
Sex: MALE
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Short and long-term complications of male circumcisions using thermocautery was examined during 2 years period.

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).
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate
timeFrame: perioperative (during circumcision) - 6 months after circumcision
Secondary outcomes:
measure: Surgical processing time
timeFrame: 4-15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Afyon Kocatepe University
name: Ahmet Ali Tuncer, Asst Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: