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
| Registry | NCT04902898, acronym CiCi-2021 |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 100 (Estimated) |
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| Sponsor | University of Thessaly (Other) |
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| Conditions | Phimosis, Foreskin; Tightness, Redundant Prepuce |
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| Interventions | Circumcision in adults using sterile single-use circular stapling device, Circumcision in adults (Device, procedure) |
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| Dates | start 2021-05-11, primary completion 2023-10-31 (estimated), completion 2023-10-31 (estimated), first posted 2021-05-26, last updated 2022-01-26 |
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| Locations | 1 site in Greece |
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Related Papers Related Patents Related Grants Related Experts
All trials for Phimosis All trials for Foreskin; Tightness All trials of Circumcision in adults using sterile single-use circular stapling device All trials of Circumcision in adults
-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)
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Circumcision | Other | Procedure: Circumcision in adults | Adult patients treated with circumcision |
| Circumcision with device | Active comparator | Device: Circumcision in adults using sterile single-use circular stapling device | Adult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) |
- Circumcision in adults using sterile single-use circular stapling device (Device), also known as 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)
- Circumcision in adults (Procedure), also known as Circumcision: Circumcision in adults
+Outcome measures
Primary outcomes
- Bleeding [Intraoperatively]: Number of gauzes used intraoperatively
- Postoperative hematoma [First postoperative day]: Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
- Postoperative hematoma [Seventh postoperative day]: Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
- 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 outcomes
- Postoperative oedema [First postoperative day]: Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
- Postoperative oedema [Seventh postoperative day]: Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
- 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
Other outcomes
- 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
- Anaesthesia [Immediately preoperatively]: Quantity of applied lidocaine hydrochloride 2% w/v in milliliters
- Used sutures [Intraoperatively]: Absolute number of used sutures
+Eligibility
Sex: Male, ages: 16 Years to 100 Years
Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce
Exclusion criteria : active inflammation of foreskin
+Locations (1)
| Facility | City | Country | Status |
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| Urology Department, University of Thessaly, University Hospital of Larissa | Larissa, Larissa/Thessaly | Greece | Recruiting |
+Investigators