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

Phimosis Clinical Trial

— CiCi-2021  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902898
• Other study ID #: 49616/11.05.2021
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2022
• Source: University of Thessaly
• Contact: Vasileios Tzortzis, Professor
• Phone: 00302413502811
• Email: urologydpt.uth[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 100 Years

Eligibility

Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce

Exclusion criteria : active inflammation of foreskin

Related Conditions & MeSH terms

• Phimosis

Intervention

Device:
• Circumcision 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)

Procedure:
• Circumcision in adults
Circumcision in adults

Locations

Country	Name	City	State
Greece	Urology Department, University of Thessaly, University Hospital of Larissa	Larissa	Larissa/Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Anaesthesia	Quantity of applied lidocaine hydrochloride 2% w/v in milliliters	Immediately preoperatively
Other	Used sutures	Absolute number of used sutures	Intraoperatively
Primary	Bleeding	Number of gauzes used intraoperatively	Intraoperatively
Primary	Postoperative hematoma	Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation	First postoperative day
Primary	Postoperative hematoma	Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation	Seventh postoperative day
Primary	Postoperative oedema	Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation	Twenty first postoperative day
Primary	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	Postoperative oedema	Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation	First postoperative day
Secondary	Postoperative oedema	Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation	Seventh postoperative day
Secondary	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