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

Sponsor

Kocatepe University (Other)

Overall Status

Completed

CT.gov ID

NCT03136224

Collaborator

(none)

2,062

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Circumcision, Male	Device: Thermocautery Device: Plastic Clamping Device: Surgical Circumcision	N/A

Detailed Description

The study was carried out in accordance with the Helsinki declaration rules, with the approval of the local ethics committee. Male patients who applied to Hakkari State Hospital and Yüksekova State Hospital pediatric surgery clinics between May 2014 and May 2015 for the circumcision operation were analyzed retrospectively by using the hospital registry system. Patients were evaluated in terms of age groups, accompanying pathologies, anesthesia techniques, duration of the surgery, complication rates, and circumcision techniques. Data obtained from the study were transferred to a computer environment and assessed 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. The distribution of the data was tested by using one of the normality tests such as Shapiro-Wilk test in case of the comparison of surgical time. Kruskal Wallis test was used for nonparametric tests in group comparisons when data were not normally distributed. The Dunn test was used as a post-hoc test when different groups were determined. P <0.05 was considered statistically significant.

Circumcision was performed by a pediatric surgeon and an assistant health professional under sterile conditions in the operating room or circumcision room.

Penile block and local infiltration anesthesia (penile ring block, penile dorsal nerve block) were performed to all other patients with Bupivacaine, and Prilocaine. Open surgery, thermocautery, and plastic clamp (Alisklamp) methods were used as circumcision techniques.

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 ensured by using the 5/0 absorbable suture. Medical dressing was done.

Alisklamp 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.

In the thermocautery method, a digital thermocautery device 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.

Routine warm sitting pool and daily medical dressing were recommended after circumcision. Furthermore, it was recommended to patients with phimosis to apply epithelium cicatrising cream. On the 10th postoperative day, all patients were recruited for routine control. Patients with complications were followed up for a long term. Complications were treated.

Study Design

Study Type:

Interventional

Actual Enrollment :

2062 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Thermocautery group Plastic clamping group Classic (Surgical) circumcision groupThermocautery group Plastic clamping group Classic (Surgical) circumcision group

Masking:

Single (Outcomes Assessor)

Masking Description:

Statistician was masked

Primary Purpose:

Other

Official Title:

Comparison of Short and Long Term Complications According to the Circumcision Technique Applied During the Childhood

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thermocautery 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 Other Names: Experimental
Active Comparator: Plastic Clamping 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 Other Names: Active comparator Alisklamp
Sham Comparator: Surgical Circumcision 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 Other Names: sham comparator

Arm

Intervention/Treatment

Experimental: Thermocautery

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

Other Names:

Experimental

Active Comparator: Plastic Clamping

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

Other Names:

Active comparator

Alisklamp

Sham Comparator: Surgical Circumcision

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

Other Names:

sham comparator

Outcome Measures

Primary Outcome Measures

Complication rate [May 2014 and May 2015 (circumcised in 1 year period)]
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.

Secondary Outcome Measures

Surgical processing time [May 2014 and May 2015 (circumcised in 1 year period)]
Surgical processing time of groups were analyzed retrospectively by using the hospital registry system

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Week to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:Circumcised by Thermocautery, Alisklamp and surgical circumcision techniques

Exclusion Criteria: Other circumcision Techniques (Tara, Mogen clamp...) excluded

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kocatepe University

Investigators

Principal Investigator: Ahmet Ali Tuncer, Asst Prof Dr, Afyon Kocatepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmet Ali Tuncer, Asst Prof Dr, Kocatepe University

ClinicalTrials.gov Identifier:

NCT03136224

Other Study ID Numbers:

2011-KAEK-2. 2016/3:35

First Posted:

May 2, 2017

Last Update Posted:

May 2, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmet Ali Tuncer, Asst Prof Dr, Kocatepe University

circumcision

Thermocautery

Clamp

Surgical Circumcision

Study Results

No Results Posted as of May 2, 2017