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Completed

NCT Number: NCT03634358

Bipolar Scissors for Circumcision

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

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Key information

Conditions

Male Circumcision

Age range

40 day–18 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bipolar scissors

Procedure

classic scalpel

Procedure

Primary outcomes

  1. Post-operative bleeding

    Time frame: A week

    occurrence of active bleeding after circumcision

Secondary outcomes

  1. 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

  2. wound complications

    Time frame: Two weeks

    occurrence of infection, necrosis or skin loss around wound

  3. Cosmetic outcome

    Time frame: Two month

    Presence or absence of scar

  4. Operative time

    Time frame: Operative time

    Duration of procedure of both techniques

  5. Over or under correction

    Time frame: 2 month

    Excessive or insufficient removal of foreskin (presence of redundant skin or compression of penile length)

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Bipolar Scissors Versus Classic Method for Circumcision

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2018
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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