The Safety of Thermocautery Usage for Male Children's Circumcisions

NCT03305523 | Completed

• 1 other identifier: 2011-KAEK-2 2017/2:52
• Study Type: interventional
• Target: 1,780
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Circumcision, Male

Keywords

circumcision; Thermocautery; Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Surgical processing time

  4-15 minutes

Study Arms (1)

Thermocautery

EXPERIMENTAL

Circumcision with thermocautery technique was applied all participants

Device: Thermocautery

Interventions

Thermocautery 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

Also known as: Study group

Thermocautery

Eligibility Criteria

• Age: 2 Weeks - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who circumcised by Thermocautery device Patients without additional disease between 2 weeks and 18 years included in the study Male gender

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocatepe University: lead

Study Officials

• Ahmet Ali Tuncer, Asst Prof Dr

  Afyon Kocatepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Dr

Model Details: 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).

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2016
• Last Updated: October 10, 2017

Record last verified: 2017-10