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

Not Applicable

• Conditions: Redundant Prepuce; Phimosis; Foreskin; Tightness

• Registration Number: NCT04902898
• Lead Sponsor: University of Thessaly

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-11
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bleeding	Intraoperatively	Number of gauzes used intraoperatively
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Urology Department, University of Thessaly, University Hospital of Larissa; 🇬🇷 Larissa, Larissa/Thessaly, Greece