Clinical trial NCT05152511: Management of Post-circumcision Ischemia Using Hyperbaric Oxygen Therapy
Official title: Management of Post-circumcision Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-circumsion Complications
Keywords: Glans necrosis,
Hyperbaric oxygen,
Male Circumcision,
Pentoxifylline,
Monopolar cautery.
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 23
Sex: MALE
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty-three male children with penile ischaemia from 3076 post-circumcisions complicated patients.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- male children complained of penile ischaemia after circumcision.

Exclusion Criteria:

* other post-circumcision complication not include penile ischaemia
* patients with chronic diseases.

Primary outcomes:
measure: post-circumcision complication
timeFrame: April 2017 and October 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sarah Magdy Abdelmohsen
Study officials:
affiliation: Aswan University
name: Sarah M Abdelmohsen
role: PRINCIPAL_INVESTIGATOR
References: