Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) (CiCi-2021)

January 25, 2022 updated by: Vasileios Tzortzis, University of Thessaly

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Larissa/Thessaly
      • Larissa, Larissa/Thessaly, Greece, 41110
        • Recruiting
        • Urology Department, University of Thessaly, University Hospital of Larissa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vasileios Tzortzis, Professor
        • Sub-Investigator:
          • Lampros Mitrakas, Consultant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria :phimosis, stenosis of foreskin, redundant prepuce

Exclusion criteria : active inflammation of foreskin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Circumcision
Adult patients treated with circumcision
Procedure: Circumcision in adults
Circumcision in adults
Other Names:
  • Circumcision
Active Comparator: Circumcision with device
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
Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Other Names:
  • Sterile single-use circular stapling device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: Intraoperatively
Number of gauzes used intraoperatively
Intraoperatively
Postoperative hematoma
Time Frame: First postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
First postoperative day
Postoperative hematoma
Time Frame: Seventh postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Seventh postoperative day
Postoperative oedema
Time Frame: Twenty first postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Twenty first postoperative day
Duration of procedure
Time Frame: 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
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
Time Frame: First postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
First postoperative day
Postoperative oedema
Time Frame: Seventh postoperative day
Measurement defined as follows: mild=1, moderate=2 and large=3, according to the surgeon's estimation
Seventh postoperative day
Aesthetic result
Time Frame: 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
Nineteenth postoperative day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain feeling
Time Frame: 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
Intraoperatively
Anaesthesia
Time Frame: Immediately preoperatively
Quantity of applied lidocaine hydrochloride 2% w/v in milliliters
Immediately preoperatively
Used sutures
Time Frame: Intraoperatively
Absolute number of used sutures
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Principal Investigator: Vasileios Tzortzis, Professor, Urology Department, University of Thessaly, University Hospital of Larissa, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49616/11.05.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

After a publication and for a period of 2 years

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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