Bipolar Scissors for Circumcision

August 13, 2018 updated by: yousef ahmed el-ayman, Zagazig University

Bipolar Scissors Versus Classic Method for Circumcision

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, randomized study, comparing two different techniques for pediatric male circumcision: the bipolar diathermy scissors technique with that of a classic scalpel technique. Study included male infants from 40 days old up to 18 month old. They were reviewed regarding Operative time, bleeding, complications, postoperative pain and morbidity. Differences in the outcome were compared.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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

1 month to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bipolar scissors group
Group of male infants undergoing circumcision using bipolar scissors to separate the foreskin
Procedure: Bipolar scissors
ACTIVE_COMPARATOR: Classic scalpel group
Group of male infants undergoing circumcision using classic scalpel to separate the foreskin, and sutures to control bleeding
Procedure: classic scalpel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative bleeding
Time Frame: A week
occurrence of active bleeding after circumcision
A week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: A week

pain after operation as assessed and described by parents (through a questionnaire) by the Neonatal/Infant Pain Scale (NIPS): It is composed of six (6) indicators.

  • facial expression
  • cry
  • breathing patterns
  • arms
  • legs
  • state of arousal Each behavioral indicator is scored with 0 or 1 except "cry", which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants should be observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7. Pain Level is determined as: 0-2 = mild to no pain. 3-4 = mild to moderate pain >4 = severe pain
A week
wound complications
Time Frame: Two weeks
occurrence of infection, necrosis or skin loss around wound
Two weeks
Cosmetic outcome
Time Frame: Two month
Presence or absence of scar
Two month
Operative time
Time Frame: Operative time
Duration of procedure of both techniques
Operative time
Over or under correction
Time Frame: 2 month
Excessive or insufficient removal of foreskin (presence of redundant skin or compression of penile length)
2 month

Collaborators and Investigators

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

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2016

Primary Completion (ACTUAL)

January 10, 2018

Study Completion (ACTUAL)

January 10, 2018

Study Registration Dates

First Submitted

January 13, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (ACTUAL)

August 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZagazigUH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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