NCT06177834

Brief Summary

In this study the plan is to compare the circumcision performed with Alisklamp versus Dorsal Slit Sleeve method in terms of age, co-existing health conditions, surgery time, recovery period, tissue edema and bleeding, postoperative infection, wound healing, wound dehiscence, skin tunnel, and overall complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

November 24, 2023

Last Update Submit

April 12, 2024

Conditions

Circumcision

Outcome Measures

Primary Outcomes (4)

  • Healing time

    Healing time

    2 weeks

  • infections

    wound infections

    2 weeks

  • wound dehiscence

    wound dehiscence

    2 weeks

  • skin tunnel

    presense of the number of skin tunnel

    1 month

Study Arms (2)

Classical dorsal slit circumcision technique

ACTIVE COMPARATOR

In this group, the patients who will operated with dorsal sleeve slit circumcision technique.

Other: Dorsal slit circumcision technique

Alisklamp

EXPERIMENTAL

In this group, the patients who will operated with Alisklamp technique.

Device: Alisklamp

Interventions

AlisklampDEVICE

Alisklamp

Alisklamp
Dorsal slit circumcision techniqueOTHER

In this group, included the patients who will operated with dorsal slit circumcision technique

Classical dorsal slit circumcision technique

Eligibility Criteria

Age1 Minute - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • male patients between 0-2 years and 6-18 years

You may not qualify if:

  • years, several penil chordee, hypospadias, previous penil surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Azizoğlu

Istanbul, 34430, Turkey (Türkiye)

Location

Study Officials

  • Mustafa Azizoğlu

    Necmi Kadıoğlu State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 20, 2023

Study Start

December 20, 2023

Primary Completion

January 20, 2024

Study Completion

March 1, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)