The Safety of Thermocautery Usage for Male Children's Circumcisions

NCT ID: NCT03305523

Last Updated: 2017-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2016-05-01

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.

Conditions

Circumcision, Male

Keywords

circumcision; Thermocautery; Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Thermocautery

Circumcision with thermocautery technique was applied all participants

Group Type: EXPERIMENTAL

Thermocautery

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Study group

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

• Minimum Eligible Age: 2 Weeks
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kocatepe University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Ali Tuncer

Asst Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet Ali Tuncer, Asst Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Afyon Kocatepe University

Other Identifiers

2011-KAEK-2 2017/2:52

Identifier Type: -

Identifier Source: org_study_id