An observational study in Post-circumsion Complications, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to male participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2021-12-10.
Sponsored by Aswan University Hospital · Observational
Background: Post-circumcision penile ischaemia is a rare but destructive complication. Our goal is to present our experience in the management of children, who had different forms of penile ischaemia, complicating the routine ritual male circumcision.
Material and Methods: All male children who had post-circumcision penile ischaemia between April 2017 and October 2020 were included in the study. A special designed protocol for management of all cases includes a combination of early Pentoxifylline intervenes infusion with Hyperbaric Oxygen inhalation, early catheterization, and appropriate surgical debridement. Data were analyzed inclusively to patient age, the anesthesia method used, Monopolar diathermy usage, early presentation, method of circumcision and positive wound culture.
It is a cohort prospective study. All male children who had penile ischaemia after circumcision were included in the study between April 2017 and October 2020. A special designed protocol includes early admission of a child in Paediatric intensive care unit (PICU). Catheterization by suitable size silicon Foley's catheter appropriate for the age. IV Pentoxifylline in a dose of 10 mg/kg/day divided into 3 equal doses with good monitoring of its side effects mainly tachycardia and convulsions. IV 3rd generation cephalosporin with suitable doses according to the age and body weight. Hyperbaric Oxygen therapy is a specially designed cabinet for infants and neonates with a barometric pressure equal to 760 mmHg for 20 minutes daily, then gradually increase up to one hour daily for 5 days per week (fig. 1). The chamber was kept warm. The babies were fed before entering the chamber and if signs of hunger appear during therapy. The baby was continuously monitored with pulse oximeter. Older children are managed in the conventional Hyperbaric Oxygen chamber with the same regimen. Proper surgical debridement together with daily topic dressing with nitroglycerin ointment (2%). The treatment continued through the admission period. Follow up period range from 6 months up to 3 years.
Data were analyzed inclusively to patient age, the type of medical provider who performed the circumcision, the technique of male circumcision, the anesthesia method used, if any Monopolar diathermy usage, wound suturing after MC, the duration of between male circumcision and presentation to our protocol, and the final condition of the patient at discharge and after 6 months.
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This study's enrollment of 23 is below the median of 181 across 617 observational studies indexed under Ischemia.
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Twenty-three male children with penile ischaemia from 3076 post-circumcisions complicated patients.
Exclusion Criteria:
It is a cohort prospective study. All male children who had penile ischaemia after circumcision were included in the study between April 2017 and October 2020.
Combination Product: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy is a specially designed cabinet for infants and neonates with a barometric pressure equal to 760 mmHg for 20 minutes daily, then gradually increase up to one hour daily for 5 days per week (fig. 1). The chamber was kept warm. The babies were fed before entering the chamber and if signs of hunger appear during therapy. The baby was continuously monitored with pulse oximeter. Older children are managed in the conventional Hyperbaric oxygen chamber with the same regimen.
Also known as: Pentoxifylline
post-circumcision complication
early and late complication
Time frame: April 2017 and October 2020
Plan to share: Undecided
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Aswan University Hospital