Bipolar Scissors for Circumcision

Male Circumcision Clinical Trial

Official title:

Bipolar Scissors Versus Classic Method for Circumcision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634358
• Other study ID #: ZagazigUH
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 10, 2018

Study information

• Verified date: August 2018
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Days to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Male Circumcision

Intervention

Procedure:
• Bipolar scissors

• classic scalpel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

References & Publications (1)

Méndez-Gallart R, Estévez E, Bautista A, Rodríguez P, Taboada P, Armas AL, Pradillos JM, Varela R. Bipolar scissors circumcision is a safe, fast, and bloodless procedure in children. J Pediatr Surg. 2009 Oct;44(10):2048-53. doi: 10.1016/j.jpedsurg.2009.06.008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative bleeding	occurrence of active bleeding after circumcision	A week
Secondary	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
Secondary	wound complications	occurrence of infection, necrosis or skin loss around wound	Two weeks
Secondary	Cosmetic outcome	Presence or absence of scar	Two month
Secondary	Operative time	Duration of procedure of both techniques	Operative time
Secondary	Over or under correction	Excessive or insufficient removal of foreskin (presence of redundant skin or compression of penile length)	2 month