Clinical trial NCT06766838: Outcomes Of The Different Techniques Of Male Circumcision
Official title: Outcomes Of The Different Techniques Of Male Circumcision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prepuce; Accessory
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 100
Sex: MALE
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding
timeFrame: 1 day
Secondary outcomes:
measure: Cosmetic appearance
timeFrame: 1 month
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
citation: [1] Myers A, Earp B. What Is the Best Age to Circumcise? A Medical and Ethical Analysis. Bioethics. 2020;34:645-663. [2] Schneider, T., 2013. Ancient Egypt investigated: 101 important questions and intriguing answers. Bloomsbury Publishing. [3] Alanis MC, Lucidi RS. Neonatal circumcision: a review of the world's oldest and most controversial operation. Obstet Gynecol Surv 2004;59(5):379e95. [4] Abdulwahab-Ahmed, A. and Mungadi, I.A., 2013. Techniques of male circumcision. Journal of surgical technique and case report, 5(1), pp.1-7. [5] Deacon, M. and Muir, G., 2023. What is the medical evidence on non-therapeutic child circumcision?. International journal of impotence research, 35(3), pp.256-263. [6] Iacob, S.I., Feinn, R.S. and Sardi, L., 2022. Systematic review of complications arising from male circumcision. BJUI compass, 3(2), pp.99-123. [7] Prakash, K.P., 2019. Comparative Study of Frenulum Sparing Circumcision with Dorsal Slit-Sleeve Technique of Circumcision for Phimosis (Master's thesis, Rajiv Gandhi University of Health Sciences (India). [8] Prabhakaran S, Ljuhar D, Coleman R, Nataraja RM. Circumcision in the paediatric patient: a review of indications, technique and complications. J Paediatr Child Health. 2018;54(12):1299-307. [9] Zafar, G.M., Sajjad, M.N., Zaheer, M., Yousaf, M.H. and Javeed, M.N., 2024. Split Glans & Advancement Flap To Repair Penile Hair Tourniquet Injury In Children: A Challenging Problem Of Unknown Etiology. Pakistan Journal of Urology (PJU), 2(01), pp.82-87. [10] Wang X, Dong C, Beekoo D et al. (2019): Dorsal penile nerve block via perineal approach, an alternative to a caudal block for pediatric circumcision: a randomized controlled trial. BioMed Research International, 19:6875756. doi: 10.1155/2019/6875756. [11] Kamil M (2012): Bone cutter circumcision in neonates. AL-Kindy College Medical Journal, 8(1): 119-121. [12] Wan J (2002): Gomco circumcision clamp: an enduring and unexpected success. Urology, 59(5): 790- 794. [13] Morris B, Eley C (2011): Male circumcision: An appraisal of current instrumentation. Biomedical Engineering, University of Rijeka, Rijeka, Pp. 315-354. DOI: 10.5772/18543