Male Circumcision
Conditions
Keywords
bipolar, scalpel, foreskin, prepuce
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.
Interventions
PROCEDUREBipolar scissors
PROCEDUREclassic scalpel
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Comparing Outcomes of two different surgical techniques between two groups
Eligibility
Sex/Gender
MALE
Age
40 Days to 18 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative bleeding | A week | occurrence of active bleeding after circumcision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| wound complications | Two weeks | occurrence of infection, necrosis or skin loss around wound |
| Cosmetic outcome | Two month | Presence or absence of scar |
| Operative time | Operative time | Duration of procedure of both techniques |
| Over or under correction | 2 month | Excessive or insufficient removal of foreskin (presence of redundant skin or compression of penile length) |
Outcome results
None listed