Foreskin; Tightness, Phimosis, Redundant Prepuce
Conditions
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)
Interventions
DEVICECircumcision in adults using sterile single-use circular stapling device
Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
PROCEDURECircumcision in adults
Circumcision in adults
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
:phimosis, stenosis of foreskin, redundant prepuce
Exclusion criteria
: active inflammation of foreskin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hematoma | First postoperative day | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation |
| Bleeding | Intraoperatively | Number of gauzes used intraoperatively |
| Postoperative oedema | Twenty first postoperative day | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation |
| Duration of procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic result | Nineteenth postoperative day | 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 |
| Postoperative oedema | First postoperative day | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain feeling | Intraoperatively | Visual analogue scale from 0 to 10, as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = very severe pain and 10 = worst possible pain, according to the patient's estimation |
| Used sutures | Intraoperatively | Absolute number of used sutures |
| Anaesthesia | Immediately preoperatively | Quantity of applied lidocaine hydrochloride 2% w/v in milliliters |
Countries
Greece
Contacts
Primary ContactVasileios Tzortzis, Professor
Backup ContactLampros Mitrakas, Consultant
Outcome results
None listed