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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circumcision | Other | Adult patients treated with circumcision |
|
| Circumcision with device | Active Comparator | Adult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circumcision in adults using sterile single-use circular stapling device | Device | Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Number of gauzes used intraoperatively | Intraoperatively |
| Postoperative hematoma | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation | First postoperative day |
| Postoperative hematoma | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation | Seventh postoperative day |
| Postoperative oedema | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation | Twenty first postoperative day |
| Duration of procedure | Minutes | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative oedema | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation | First postoperative day |
| Postoperative oedema | Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation |
| Measure | Description | Time Frame |
|---|---|---|
| Pain feeling | 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 | Intraoperatively |
| Anaesthesia |
Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce
Exclusion criteria : active inflammation of foreskin
Only males suffer from foreskin pathologic conditions
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasileios Tzortzis, Professor | Contact | 00302413502811 | urologydpt.uth@gmail.com | |
| Lampros Mitrakas, Consultant | Contact | 00302413501325 | lamprosmit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vasileios Tzortzis, Professor | Urology Department, University of Thessaly, University Hospital of Larissa, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Department, University of Thessaly, University Hospital of Larissa | Recruiting | Larissa | Larissa/Thessaly | 41110 | Greece |
All IPD that underlie results in a publication
After a publication and for a period of 2 years
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|
| Circumcision in adults | Procedure | Circumcision in adults |
|
|
| 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 | Nineteenth postoperative day |
Quantity of applied lidocaine hydrochloride 2% w/v in milliliters
| Immediately preoperatively |
| Used sutures | Absolute number of used sutures | Intraoperatively |
| ID | Term |
|---|---|
| D010688 | Phimosis |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002944 | Circumcision, Male |
| ID | Term |
|---|---|
| D046289 | Body Modification, Non-Therapeutic |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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