Outcomes Of The Different Techniques Of Male Circumcision

Sohag University

Status: Enrolling

Conditions: Prepuce; Accessory

Treatments: Procedure: 6. Plastibell device technique (Group F):; Procedure: 5. Gomco clamp technique (Group E):; Procedure: 1. Conventional dissection technique (group A) :; Procedure: 3. Electro-cauterization (bipolar) assisted circumcision (Group C); Procedure: 4. Thermal cauterization assisted circumcision (Group D); Procedure: 2. Bone cutting forceps technique (Group B)

Study type: Interventional

Funder types: Other

Identifiers

NCT06766838

Soh-Med--24-12-02MS

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: Male

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 6 patient groups

1. Group A: Conventional dissection technique;

Active Comparator group

Description:

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

Treatment:

Procedure: 1. Conventional dissection technique (group A) :

2. Group B: Bone cutting ;

Active Comparator group

Description:

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

Treatment:

Procedure: 2. Bone cutting forceps technique (Group B)

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

Active Comparator group

Description:

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.

Treatment:

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

4. Group D: Thermal cauterization assisted circumcision;

Active Comparator group

Description:

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.

Treatment:

Procedure: 4. Thermal cauterization assisted circumcision (Group D)

5. Group E: Gomco clamp technique;

Active Comparator group

Description:

The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, and then the bell is applied gently to the glans. The base plate is placed over the metal bell. The foreskin then is protracted back over the bell with the clamps still attached. The foreskin is drawn evenly through the hole bilaterally using the ink mark as a guide. The clamp then is tightened and left in place for 5 minutes to squeeze the prepuce between the bell and the clamp to make it blood free before a circumferential incision is made.

Treatment:

Procedure: 5. Gomco clamp technique (Group E):

6. Group F: Plastibell device technique.

Active Comparator group

Description:

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.

Treatment:

Procedure: 6. Plastibell device technique (Group F):