Bipolar Scissors for Circumcision

Not Applicable

Completed

• Conditions: Male Circumcision
• Interventions: Procedure: classic scalpel; Procedure: Bipolar scissors

• Registration Number: NCT03634358
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Study First Submitted: 2018-01-13
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-16
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic scalpel group	classic scalpel	Group of male infants undergoing circumcision using classic scalpel to separate the foreskin, and sutures to control bleeding
Bipolar scissors group	Bipolar scissors	Group of male infants undergoing circumcision using bipolar scissors to separate the foreskin

Primary Outcome Measures

Name	Time	Method
Post-operative bleeding	A week	occurrence of active bleeding after circumcision

Secondary Outcome Measures

Name	Time	Method
Over or under correction	2 month	Excessive or insufficient removal of foreskin (presence of redundant skin or compression of penile length)
wound complications	Two weeks	occurrence of infection, necrosis or skin loss around wound
Cosmetic outcome	Two month	Presence or absence of scar
Post-operative pain	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
Operative time	Operative time	Duration of procedure of both techniques