Examination of Short and Long Term Complications of Thermocautery, Plastic Clamping and Surgical Circumcision Techniques

NCT03136224 | Completed

• 1 other identifier: 2011-KAEK-2. 2016/3:35
• Study Type: interventional
• Target: 2,062
• 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. In this study, thermocautery, plastic clamping, and conventional (open surgical) circumcision techniques were compared to each other in terms of their short and long term complications.

Conditions

Circumcision, Male

Keywords

circumcision; Thermocautery; Clamp; Surgical Circumcision

Outcome Measures

Primary Outcomes (1)

• Complication rate

  The diversity in circumcision techniques is because of the search for a more practical, cheaper, safer, and less complicated technique. In this study, complications of circumcisions performed by pediatric surgeon specialists by using three different techniques (thermocautery, alisklamp, and surgical circumcision) in two different hospitals in Turkey were investigated retrospectively.

  May 2014 and May 2015 (circumcised in 1 year period)

Secondary Outcomes (1)

• Surgical processing time

  May 2014 and May 2015 (circumcised in 1 year period)

Study Arms (3)

Thermocautery

EXPERIMENTAL

In the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medikal, 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

Device: Thermocautery

Plastic Clamping

ACTIVE COMPARATOR

Alisklamp (Alisklamp, Abagrup Health Services Ltd, Ankara, Turkey) was used in the plastic clamp technique. The clamp size was chosen according to the diameter of the penis of the patient. The clamp was inserted into the glans and then the skin and the mucosa were pulled to the appropriate size and clamped. The skin and mucosa were excised from the distal part of the clamp with the aid of a lancet. After the operation, the clamp was removed on the 4th day

Device: Plastic Clamping

Surgical Circumcision

SHAM COMPARATOR

In classical surgical circumcision, foreskin was hung up with the clamp. The outer skin and secondly the mucosa was cut by using scissors. Following the hemorrhage intervention, the skin-mucosa integrity was sutured by using the 5/0 absorbable suture. Medical dressing was done.

Device: Surgical Circumcision

Interventions

Thermocautery DEVICE

Also known as: Experimental

Thermocautery

Plastic Clamping DEVICE

Also known as: Active comparator, Alisklamp

Plastic Clamping

Surgical Circumcision DEVICE

Also known as: sham comparator

Surgical Circumcision

Eligibility Criteria

• Age: 1 Week - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician was masked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Dr

Model Details: Thermocautery group Plastic clamping group Classic (Surgical) circumcision group

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: May 2, 2017
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 2, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share