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

NCT ID: NCT03136224

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2062 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2015-05-01

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. 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.

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.

Conditions

Circumcision, Male

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Thermocautery

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

Plastic Clamping

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Surgical Circumcision

Intervention Type: DEVICE

Interventions

Thermocautery

Intervention Type: DEVICE

Plastic Clamping

Intervention Type: DEVICE

Surgical Circumcision

Intervention Type: DEVICE

Other Intervention Names

Experimental; Active comparator; Alisklamp; sham comparator

Eligibility Criteria

Inclusion Criteria

-

• Minimum Eligible Age: 1 Week
• 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. 2016/3:35

Identifier Type: -

Identifier Source: org_study_id