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 Adult Patients Suffering From Pathologic Foreskin (Phimosis, Stenosis, Redundant Prepuce): A Prospective Randomised Comparative Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Thessaly
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Postoperative oedema
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 100 Years (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •phimosis, stenosis of foreskin, redundant prepuce
Exclusion Criteria
- •active inflammation of foreskin
Arms & Interventions
Circumcision
Adult patients treated with circumcision
Intervention: Circumcision in adults (Procedure)
Circumcision with device
Adult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Intervention: Circumcision in adults using sterile single-use circular stapling device (Device)
Outcomes
Primary Outcomes
Postoperative oedema
Time Frame: Twenty first postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Bleeding
Time Frame: Intraoperatively
Number of gauzes used intraoperatively
Postoperative hematoma
Time Frame: Seventh postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Duration of procedure
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)
Minutes
Postoperative hematoma
Time Frame: First postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Secondary Outcomes
- Postoperative oedema(Seventh postoperative day)
- Aesthetic result(Nineteenth postoperative day)
- Postoperative oedema(First postoperative day)
Investigators
Vasileios Tzortzis
Professor of Urology
University of Thessaly