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IRCT20230513058160N1 IRCT 2023-05-27 Esfahan University of Medical Sciences The result of full-thickness femoral graft for the correction of concealed penis Investigation of the outcome of full thickness thigh graft for the correction of concealed penis in boys aged 7 to 14 years 2021-10-23 anticipated 100 Complete https://irct.ir/trial/70079 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Concealed penis. Intervention 1: Intervention group: After admitting the patient to perform the operation, he is placed under general anesthesia and placed in the low lithotomy position. After prep and drape, the genital area and lower limbs are placed in the field. A median longitudinal incision is made on the ventral penile skin from the phimotic ring to the penoscrotum junction. For traction with Prolene 5.0, a permanent suture is placed at a distance of 5 mm from the edge of the glans and remains until the end of the operation. A peripheral cut is created according to the initial opening. Degloving is performed by dissection of all the dartos fascia of the penis and fibrous tissues from the fascia of the pelvis. Then, after tying a tourniquet at the base of the penis and injecting normal saline, the amount of cord is checked. If the severity of the cord is more than 10 degrees, the cord is corrected by Dorsal Plication with 0-5 Prolen thread using the Nezbit method. The subcutaneous tissue of the junction of the penoscrotum is dissected ventrally at the 6 o'clock position. This simplifies the dissection of the fat tissue of the genital area from the back to the pubic ligaments at 12 o'clock. Then, a full thickness graft with a length of 1.5 times the defect and a width of 1 cm is removed from the non-dominant thigh and defatted. It is useful to use the inguinal skin because it is hairless and next to the penis, and the resulting scar is easily hidden under clothing. Then the graft is transferred to the operation site and fixed at 12, 3, and 9 o'clock, and at 6 o'clock the genital area of the graft is repaired in the form of a ring. 0-4 is sewn. Urethral catheter is inserted based on the age of the patient. Antibiotics are started during induction of anesthesia and are maintained for 3 to 5 days. It ends. After 48 hours, the dressing is removed and the color of the graft is checked. Intervention 2: Control group: After admitting the patient for the operation, he is placed under general anesthesia and placed in the supine position. After preparation and drape of the genital area, a longitudinal incision is made on the skin of the abdominal penis from the phimotic ring to the junction of the penoscrotum. is created For traction with Prolene 5.0, a permanent suture is placed at a distance of 5 mm from the edge of the glans and remains until the end of the operation. A peripheral cut is created according to the initial opening. Degloving is performed by dissection of all the dartos fascia of the penis and fibrous tissues of the pelvic fascia. The subcutaneous tissue of the junction of the penoscrotum is dissected ventrally at the 6 o'clock position. This simplifies the dissection of the genital fat tissue from the back to the pubic ligaments at 12 o'clock. The urethral catheter is inserted based on the patient's age. Antibiotics are started during the induction of anesthesia and are maintained for 3 to 5 days. After 48 hours, the dressing is removed. In this surgical method, no graft is used and only adhesions and fibrous tissue are released. Yes - There is a plan to make this available What will be shared: After de-identifying individual information, individual complications or unintended consequences are shared When: Access starts 1 year after results are published To whom: Access for researchers in the field of pediatric surgery, urology and plastic surgery Conditions: The data can be used for reference in future researches Where to obtain: The request will be made by email with the specialist assistant of Dr. Davud Moznabi and after providing the documents of the research project and the data used in the research by the applicant and after verifying the identity of the applicant. dr.moznebi@yahoo.com How to obtain: Sending an email request and scientific and personal specifications, resume and documentary information can be requested for the research project The data will be made available as soon as possible after the confirmation of the individual inquiry and research plan Comments:
public Davud Moznebi Esfahani
No. 8 Pour Gol afshan Ave, Lonban Blvd, Esfahan
Esfahan Iran (Islamic Republic of) 8184664131 +98 31 3236 7106 dr.moznebi@yahoo.com Esfahan University of Medical Sciences scientific Davud Moznebi Esfahani
No. 8 Pour Gol afshan Ave, Lonban Blvd, Esfahan
Esfahan Iran (Islamic Republic of) 8184664131 +98 31 3236 7106 dr.moznebi@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Children with concealed penis over 7 years old 7 years 14 years Male Reluctance to continue participating in the plan Concomitant coagulation disorder N48 Other disorders of penis Treatment - Surgery Treatment - Surgery Intervention group: After admitting the patient to perform the operation, he is placed under general anesthesia and placed in the low lithotomy position. After prep and drape, the genital area and lower limbs are placed in the field. A median longitudinal incision is made on the ventral penile skin from the phimotic ring to the penoscrotum junction. For traction with Prolene 5.0, a permanent suture is placed at a distance of 5 mm from the edge of the glans and remains until the end of the operation. A peripheral cut is created according to the initial opening. Degloving is performed by dissection of all the dartos fascia of the penis and fibrous tissues from the fascia of the pelvis. Then, after tying a tourniquet at the base of the penis and injecting normal saline, the amount of cord is checked. If the severity of the cord is more than 10 degrees, the cord is corrected by Dorsal Plication with 0-5 Prolen thread using the Nezbit method. The subcutaneous tissue of the junction of the penoscrotum is dissected ventrally at the 6 o'clock position. This simplifies the dissection of the fat tissue of the genital area from the back to the pubic ligaments at 12 o'clock. Then, a full thickness graft with a length of 1.5 times the defect and a width of 1 cm is removed from the non-dominant thigh and defatted. It is useful to use the inguinal skin because it is hairless and next to the penis, and the resulting scar is easily hidden under clothing. Then the graft is transferred to the operation site and fixed at 12, 3, and 9 o'clock, and at 6 o'clock the genital area of the graft is repaired in the form of a ring. 0-4 is sewn. Urethral catheter is inserted based on the age of the patient. Antibiotics are started during induction of anesthesia and are maintained for 3 to 5 days. It ends. After 48 hours, the dressing is removed and the color of the graft is checked Control group: After admitting the patient for the operation, he is placed under general anesthesia and placed in the supine position. After preparation and drape of the genital area, a longitudinal incision is made on the skin of the abdominal penis from the phimotic ring to the junction of the penoscrotum. is created For traction with Prolene 5.0, a permanent suture is placed at a distance of 5 mm from the edge of the glans and remains until the end of the operation. A peripheral cut is created according to the initial opening. Degloving is performed by dissection of all the dartos fascia of the penis and fibrous tissues of the pelvic fascia. The subcutaneous tissue of the junction of the penoscrotum is dissected ventrally at the 6 o'clock position. This simplifies the dissection of the genital fat tissue from the back to the pubic ligaments at 12 o'clock. The urethral catheter is inserted based on the patient's age. Antibiotics are started during the induction of anesthesia and are maintained for 3 to 5 days. After 48 hours, the dressing is removed. In this surgical method, no graft is used and only adhesions and fibrous tissue are released. Phallus morphology. Timepoint: Pre-operative visit and visit one week and 1,3, 6 months after the operation. Method of measurement: The morphology of the penis is recorded by measuring the length of the penis from its root with finger pressure on both sides of the penis before surgery and in subsequent visits. Phallus function. Timepoint: Before the operation and the interval of a week and 1, 3, 6 months after the operation. Method of measurement: Relevant training is given to the parents to check and record the function of the penis during discharge, which is an assessment of the improvement of the child's urinary erection during urination. Genital hygiene. Timepoint: Before the operation and the interval of a week and 1, 3, 6 months after the operation. Method of measurement: Evaluation of the reduction of subalternal debris after surgery is done by parents at home and by clinical examination by pediatric surgery specialist in post-operative visits. Isfahan University of Medical Sciences Approved 2023-05-09 Ethics committee of Esfahan University of Medical Sciences No.8 Pour gol afshan Ave Lonban Blv Esfahan Isfehan Iran (Islamic Republic of)