NCT03634358

Brief Summary

comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

January 13, 2018

Last Update Submit

August 13, 2018

Conditions

Male Circumcision

Keywords

bipolarscalpelforeskinprepuce

Outcome Measures

Primary Outcomes (1)

  • Post-operative bleeding

    occurrence of active bleeding after circumcision

    A week

Secondary Outcomes (5)

  • Post-operative pain

    A week

  • wound complications

    Two weeks

  • Cosmetic outcome

    Two month

  • Operative time

    Operative time

  • Over or under correction

    2 month

Study Arms (2)

Bipolar scissors group

ACTIVE COMPARATOR

Group of male infants undergoing circumcision using bipolar scissors to separate the foreskin

Procedure: Bipolar scissors

Classic scalpel group

ACTIVE COMPARATOR

Group of male infants undergoing circumcision using classic scalpel to separate the foreskin, and sutures to control bleeding

Procedure: classic scalpel

Interventions

Bipolar scissorsPROCEDURE
Bipolar scissors group
classic scalpelPROCEDURE
Classic scalpel group

Eligibility Criteria

Age40 Days - 18 Months
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male infant between 40 days and 18 month old
  • parents' request and approval of circumcision

You may not qualify if:

  • previous attempts of circumcision or revision cases
  • bleeding tendency
  • congenital anomalies involving genitalia
  • age below 40 days (expected Vit. K deficiency) or above 18 month old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mendez-Gallart R, Estevez E, Bautista A, Rodriguez P, Taboada P, Armas AL, Pradillos JM, Varela R. Bipolar scissors circumcision is a safe, fast, and bloodless procedure in children. J Pediatr Surg. 2009 Oct;44(10):2048-53. doi: 10.1016/j.jpedsurg.2009.06.008.

    PMID: 19853772BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparing Outcomes of two different surgical techniques between two groups
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of general surgery, MD Candidate

Study Record Dates

First Submitted

January 13, 2018

First Posted

August 16, 2018

Study Start

January 1, 2016

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

August 16, 2018

Record last verified: 2018-08