Evaluation of the safety and efficacy of the sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in comparison with circumcision in adults patients with pathological foreskin (phimosis, stenosis, redundant prepuce)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Circumcision in adults
Urology Department, University of Thessaly, University Hospital of Larissa
Larissa, Larissa/Thessaly, Greece
RECRUITINGBleeding
Number of gauzes used intraoperatively
Time frame: Intraoperatively
Postoperative hematoma
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time frame: First postoperative day
Postoperative hematoma
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time frame: Seventh postoperative day
Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time frame: Twenty first postoperative day
Duration of procedure
Minutes
Time frame: Intraoperative (Measurement begins at the time of the beginning of the sterilisation of the surgical field and ends at the time of the completion of the bandeage of the wound)
Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time frame: First postoperative day
Postoperative oedema
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Time frame: Seventh postoperative day
Aesthetic result
Visual analogue scale from 0 to 10, as follows: 0 - 5 = unsatisfactory, 6 - 7 = moderately satisfactory, 8 - 9 = very satisfactory, 10 = excellent, according to the patient's estimation
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Time frame: Nineteenth postoperative day