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NCT Number: NCT06766838

Outcomes Of The Different Techniques Of Male Circumcision

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.

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Key information

Conditions

Prepuce; Accessory

Age range

Up to 5 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 :

  • Group A: Conventional dissection technique;
  • Group B: Bone cutting ;
  • Group C: Electro-cauterization (bipolar) assisted circumcision;
  • Group D: Thermal cauterization assisted circumcision;
  • Group E: Gomco clamp technique;
  • 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

  • Age above 15 years
  • Ambiguous genitalia
  • Congenital penile anomalies e.g. hypospadias, epispadias, buried penis, webbed penis, micropenis, congenital chordee, incomplete prepuce and mega-urethra.
  • Redo-circumcision
  • Balanitis or inflammatory process around the penis.
  • Bleeding disorders; hemophilia or thrombocytopenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age above 5 years
  • Ambiguous genitalia
  • Congenital penile anomalies
  • Redo-circumcision
  • Balanitis or inflammatory process around the penis.
  • Bleeding disorders

Treatment and study plan

1. Conventional dissection technique (group A) :

Procedure

In this group, circumcision is performed by the dorsal slit technique. A slit is made dorsally to the level of about 5 mm from the coronal sulcus, and the redundant foreskin and mucosa were excised circumferentially. Hemostasis is secured with ligation , and the cut edges are sutured with absorbable suture. Then, dressing is applied.

2. Bone cutting forceps technique (Group B)

Procedure

Two mosquito forceps are used to grasp the foreskin. The glans penis is squeezed back to avoid its injury. After that, bone cutting forceps is applied to the foreskin for 3 minutes, at the level of the mark, then the foreskin is excised by scalpel at the same level. Bleeding points are ligated and the cut edges are sutured with absorbable suture. Then, a dressing is applied

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

Procedure

The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by scissor with hemostasis by bipolar cauterization.

The skin retracted proximally after that to expose the glans. Sutures are made if there is separation between the skin and the mucous membrane.

4. Thermal cauterization assisted circumcision (Group D)

Procedure

The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by thermal cauterization. The skin retracted proximally after that to expose the glans. Sutures are made if there is separation between the skin and the mucous membrane.

5. Gomco clamp technique (Group E):

Procedure

The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. The handle is then broken off the device

6. Plastibell device technique (Group F):

Procedure

The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. The handle is then broken off the device

Primary outcomes

  1. Bleeding

    Time frame: 1 day

    combine the number of dressing, Significant bleeding is considered if the dressing is completely soaked

Secondary outcomes

  1. Cosmetic appearance

    Time frame: 1 month

    Score for parent and physician

    • Excellent 3
    • Good 2
    • Poor 1

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Bakr Ahmed

CONTACT

[email protected]

021153259080

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.