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IRCT20150124020767N4 IRCT 2020-05-28 Tabriz University of Medical Sciences Comparison of the complications of of transinguinal orchiopexy and standard orchiopexy of palpable testicles Comparison of the complications of transinguinal orchiopexy and standard orchiopexy of palpable testicles in children under two years old referred to Tabriz Children's Hospital 2020-03-20 anticipated 30 Complete https://irct.ir/trial/45006 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Individual, Using a table of random numbers, Blinding description: This study will be double-blinded. Patients after obtaining inclusion criteria to enter the study and obtain consent, according to the table of random numbers, will be divided into two groups. They will not interfere in determining the type of treatment and will not know the type of treatment before the treatment process. The analyzer will not be aware of the type of treatment (because it receives the data as a spss file in two separate groups, one and two). N/A Undescended testis. Intervention 1: Intervention group: Trans-inguinal orchiopexy. In this group, first by inguinal incision, the skin and the inguinal canal are opened in the Langer's lines. The vaginalis process is then separated and the necessary components, including the vas deferen, blood vessels, and spermatic cord, are preserved. The vaginalis process is repaired and the patient's hernia is corrected. Gubrenaculum is then discontinued. Retroperitoneal dissection is performed to release the cord so that the testicle reaches the scrotum and enough spermatic vessels length are formed. A tunnel is created along the canal to the scrotum, and the skin of the scrotum is returned to the inguinal incision with a blunt-skin clamp. The tonica vaginalis around the testicle is fixed in two places with absorbable vicryl sutures, and then the dartus layer is repaired, and then the external iliac apineurosis and skin is repaired . Patient is examined for skin tension and the time of surgery and complications during surgery (including ischemia, bleeding, hematoma and the impossibility of creating sufficient length in the spermatic cord). The patient will be discharged on the evening of the day of surgery if the clinical condition is appropriate. Follow-up examinations will be performed in the following week and one month after surgery . Three months after the surgery, the appearance will be checked and the ultrasound will be done in terms of the size and dimensions of the testicles and their location (problems caused by ischemia and atrophy). Intervention 2: Control group: In patients referred to this group, first the skin and the inguinal canal are opened in the longitudinal lines by inguinal incision. The vaginalis process is then removed and the necessary components, including thevas deferens, blood vessels, and spermatic lymphatic vessels, are preserved. The vaginalis process is repaired and the patient's hernia is corrected. The gubernaculum is then cut. Retroperitoneal dissection is performed to release the cord so that the testicle reaches the scrotum and enough spermatic vessels are formed. A tunnel is created along the canal to the scrotum, cut through the skin incision in the scrotal area, and a scalpel is inserted into the dartus muscle through the scrotal wound. With the clamp inserted into the inguinal cavity, the testicle is pulled into the scrotal wound. The testis is placed inside the dartus muscle sac. The tonic vaginalis around the testicle is fixed in two places with absorbable vicryl sutures, and then the dartus is repaired, and then the external iliac aponeurosis and skin is repaired .Patient is examined for skin tension and the time of surgery and complications during surgery (including ischemia, bleeding, hematoma and the impossibility of creating sufficient length in the spermatic cord). The patient will be discharged on the evening of the day of surgery if the clinical condition is appropriate. Follow-up examinations will be performed in the following week and one month after surgery . Three months after the surgery, the appearance will be checked and the ultrasound will be done in terms of the size and dimensions of the testicles and their location (problems caused by ischemia and atrophy). Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentifiable people When: Start of access period 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: N/A Where to obtain: Email How to obtain: As soon as possible Comments:
public Masoud Jamshidi
Sheshglan
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2250 Masoudjamshidi@gmail.com Tabriz University of Medical Sciences scientific Masoud Jamshidi
Sheshglan
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2250 Masoudjamshidi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Palpable undescended testis 6 months 10 years Male Unpalpable undescended testis Intra-abdominal testis No evidence of testis in pre-operative imaging Severely atrophic testis Bilateral undescended testis The presence of other anomalies along with the undescended testis Associated Genetic Disorders Q53.1 Undescended testicle, unilateral Treatment - Surgery Treatment - Surgery Intervention group: Trans-inguinal orchiopexy. In this group, first by inguinal incision, the skin and the inguinal canal are opened in the Langer's lines. The vaginalis process is then separated and the necessary components, including the vas deferen, blood vessels, and spermatic cord, are preserved. The vaginalis process is repaired and the patient's hernia is corrected. Gubrenaculum is then discontinued. Retroperitoneal dissection is performed to release the cord so that the testicle reaches the scrotum and enough spermatic vessels length are formed. A tunnel is created along the canal to the scrotum, and the skin of the scrotum is returned to the inguinal incision with a blunt-skin clamp. The tonica vaginalis around the testicle is fixed in two places with absorbable vicryl sutures, and then the dartus layer is repaired, and then the external iliac apineurosis and skin is repaired . Patient is examined for skin tension and the time of surgery and complications during surgery (including ischemia, bleeding, hematoma and the impossibility of creating sufficient length in the spermatic cord). The patient will be discharged on the evening of the day of surgery if the clinical condition is appropriate. Follow-up examinations will be performed in the following week and one month after surgery . Three months after the surgery, the appearance will be checked and the ultrasound will be done in terms of the size and dimensions of the testicles and their location (problems caused by ischemia and atrophy). Control group: In patients referred to this group, first the skin and the inguinal canal are opened in the longitudinal lines by inguinal incision. The vaginalis process is then removed and the necessary components, including thevas deferens, blood vessels, and spermatic lymphatic vessels, are preserved. The vaginalis process is repaired and the patient's hernia is corrected. The gubernaculum is then cut. Retroperitoneal dissection is performed to release the cord so that the testicle reaches the scrotum and enough spermatic vessels are formed. A tunnel is created along the canal to the scrotum, cut through the skin incision in the scrotal area, and a scalpel is inserted into the dartus muscle through the scrotal wound. With the clamp inserted into the inguinal cavity, the testicle is pulled into the scrotal wound. The testis is placed inside the dartus muscle sac. The tonic vaginalis around the testicle is fixed in two places with absorbable vicryl sutures, and then the dartus is repaired, and then the external iliac aponeurosis and skin is repaired .Patient is examined for skin tension and the time of surgery and complications during surgery (including ischemia, bleeding, hematoma and the impossibility of creating sufficient length in the spermatic cord). The patient will be discharged on the evening of the day of surgery if the clinical condition is appropriate. Follow-up examinations will be performed in the following week and one month after surgery . Three months after the surgery, the appearance will be checked and the ultrasound will be done in terms of the size and dimensions of the testicles and their location (problems caused by ischemia and atrophy). Complications of orchiopexy. Timepoint: One week - one month and three months after surgery. Method of measurement: Questionnaire. Testicular volume. Timepoint: Before surgery and three months after surgery. Method of measurement: Ultrasonography. Scrotal appearance. Timepoint: One week - one month and three months after surgery. Method of measurement: Inspection. Three groups without skin retraction - minimal retraction - severe scrotal retraction. Tissue ischemia. Timepoint: In duration of surgery. Method of measurement: Inspection-Ischemic testicular discoloration. Duration of surgery. Timepoint: After surgery. Method of measurement: The watch ( time in minute). Tabriz University of Medical Sciences Approved 2020-05-03 Ethics committee of Tabriz University of Medical Sciences Tabriz children"s Hospital, Sheshglan St. Tabriz East Azarbaijan Iran (Islamic Republic of)