Outcomes Of The Different Techniques Of Male Circumcision

Not Applicable

Recruiting

• Conditions: Prepuce; Accessory

• Registration Number: NCT06766838
• Lead Sponsor: Sohag University

Brief Summary

Aim of work:

The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.

Detailed Description

The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.

Patients and methods:

According to the method of circumcision used; infants were divided into 5 groups :

1. Group A: Conventional dissection technique;

2. Group B: Bone cutting ;

3. Group C: Electro-cauterization (bipolar) assisted circumcision;

4. Group D: Thermal cauterization assisted circumcision;

5. Group E: Gomco clamp technique;

6. Group F: Plastibell device technique. Place of the study: The study will be held in the department of Pediatric surgery at Sohag University Hospital.

Type of the study: Prospective comparative Cohort study. Duration of the study: The study lasts for 6 months from the acceptance of the protocol (december 2024) to (Jone 2025).

Inclusion criteria:

All uncircumcised boys with intact prepuce aged below 15 years presented at our department for routine circumcision or for medical indications.

Exclusion criteria:

1. Age above 15 years

2. Ambiguous genitalia

3. Congenital penile anomalies e.g. hypospadias, epispadias, buried penis, webbed penis, micropenis, congenital chordee, incomplete prepuce and mega-urethra.

4. Redo-circumcision

5. Balanitis or inflammatory process around the penis.

6. Bleeding disorders; hemophilia or thrombocytopenia

Study Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2024-12-29
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-04
• Study First Posted: 2025-01-09
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. All uncircumcised boys with intact prepuce
2. Age below 5 years presented at our department for routine circumcision or for medical indications.

Exclusion Criteria

1. Age above 5 years
2. Ambiguous genitalia
3. Congenital penile anomalies
4. Redo-circumcision
5. Balanitis or inflammatory process around the penis.
6. Bleeding disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bleeding	1 day	combine the number of dressing, Significant bleeding is considered if the dressing is completely soaked

Secondary Outcome Measures

Name	Time	Method
Cosmetic appearance	1 month	Score for parent and physician; * Excellent 3; * Good 2; * Poor 1

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Egypt