Bipolar Scissors for Circumcision

Study Overview
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Brief Summary
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comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method

Detailed Description
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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.

Official Title
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Bipolar Scissors Versus Classic Method for Circumcision

Conditions
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Male Circumcision

Intervention / Treatment
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* Procedure: Bipolar scissors
* Procedure: classic scalpel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Days
Maximum Age: 18 Months

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparing Outcomes of two different surgical techniques between two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bipolar scissors group<br>Group of male infants undergoing circumcision using bipolar scissors to separate the foreskin | Procedure: Bipolar scissors<br> <br> |
| Active Comparator: Classic scalpel group<br>Group of male infants undergoing circumcision using classic scalpel to separate the foreskin, and sutures to control bleeding | Procedure: classic scalpel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar, scalpel, foreskin, prepuce