Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)

Study Overview
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Brief Summary
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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)

Official Title
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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 Adult Patients Suffering From Pathologic Foreskin (Phimosis, Stenosis, Redundant Prepuce): A Prospective Randomised Comparative Clinical Trial

Conditions
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Phimosis, Foreskin; Tightness, Redundant Prepuce

Intervention / Treatment
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* Device: Circumcision in adults using sterile single-use circular stapling device
* Procedure: Circumcision in adults


Participation Criteria
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Eligibility Criteria
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Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce Exclusion criteria : active inflammation of foreskin

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Circumcision<br>Adult patients treated with circumcision | Procedure: Circumcision in adults<br>* Circumcision in adults<br>* Other names: Circumcision;|
| Active Comparator: Circumcision with device<br>Adult patients treated with sterile single-use circular stapling device CIRCCURERII (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) | Device: Circumcision in adults using sterile single-use circular stapling device<br>* Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)<br>* Other names: Sterile single-use circular stapling device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |