Examination of Short and Long Term Complications of Thermocautery, Plastic Clamping and Surgical Circumcision Techniques
Condition: Circumcision, Male
Study type: Interventional

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.
    

Intervention name(s): Thermocautery; Plastic Clamping; Surgical Circumcision
Intervention type(s): Device; Device; Device
Other intervention name(s): Experimental; Active comparator; Alisklamp; sham comparator
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Thermocautery group Plastic clamping group Classic (Surgical) circumcision group
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: circumcision; Thermocautery; Clamp; Surgical Circumcision