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IRCT20150124020767N5 IRCT 2024-03-02 Tabriz University of Medical Sciences orchiopexy in undescended testicle. Comparison of complications after surgery in undescended testicle orchiopexy with an inguinal incision with inguinal and scrotal incision methods. 2024-02-29 anticipated 50 Complete https://irct.ir/trial/73159 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization :Simple, Tools used in randomization:based on the random.org online site. Patient will be randomly assigned to two intervention and comparison groups after diagnosis and evaluation of inclusion and exclusions criteria.allocation to two groups will be done through the random.org online site without changing the sequence.In this site we enter the "numbers " section ten the "sequence generator" . As the total sample for this study is 100 psubjects the smallest value will be 1 and the largest us 100. The column should be 2 to get two series of random numbers. Then then we click on "get sequence" . The resulting sequence will be two columns of numbers that each number shows the number of entering patient and each column shows each study group that is intervention or control. The resulting numbers in each group will be entered the Excel to make them from smallest to largest. Concealment will not be done due to impossiblity. N/A Undescended testicle, unilateral. Intervention 1: Intervention group:Patients who refer to the children's hospital clinic from the February 2024 until the end of 19th May 2024 are examined first. If there is no testicle in the scrotum unilaterally and the same testicle is touched in the inguinal canal, they are included in the study. Patients with age below six months and age above two years are excluded from the study. For all patients, ultrasound is performed and the findings including the location of the testicles and the dimensions and volume of both testicles are recorded. Patients are admitted and consent to study is obtained from the parents. Patients are examined by attending physician and anesthesiologist. Initial tests include blood cell count is obtained. Patients with concomitant diseases and chronic disorders are excluded from the study. According to the order of entry into the study, patients are divided and odd numbers are included in the intervention group and even numbers are included in the comparison group. Parents are unaware of the groups. For both groups of interventions, the same general anesthesia is performed according to the anesthesia references. In the patients of the intervention group, the inguinal incision is first opened in the Langer lines of the inguinal canal area. Then the process vaginalis is removed and the necessary parts, including the vas deferens and spermatic blood and lymphatic vessels, are separated from it. The vaginal process is repaired and the patient's hernia is repaired. Then the gubernaculum is cut and hemostasis is done. The vas deferens and the spermatic vessels and the related testicle are preserved. Retro-peritoneum dissection is performed to free the cord so that the testicle reaches the scrotum and sufficient length of the spermatic vessels is created. The path of the testicle to the scrotum is opened by the surgeon's finger. Then, without cutting the scrotum, the skin of the scrotum is pulled up to the inguinal incision site by the surgeon's finger guide with a blunt tool. A pouch is formed between the skin of the scrotum and the dartos fascia. The testicle is placed inside poach and fixed to the skin of the scrotum with an absorbable suture. Then the skin along with the testicle is pulled down to the natural place. Then, the oblique external aponeurosis and subcutaneous tissue are repaired. Intervention 2: Control group: Patients who refer to the children's hospital clinic from the January 2024 until the end of 19th May 2024 are examined first. If there is no testicle in the scrotum unilaterally and the same testicle is touched in the inguinal canal, they are included in the study. Patients with age below six months and age above two years are excluded from the study. For all patients, ultrasound is performed and the findings including the location of the testicles and the dimensions and volume of both testicles are recorded. Patients are admitted and consent to study is obtained from the parents. Patients are examined by attending physician and anesthesiologist. Initial tests include blood cell count is obtained. Patients with concomitant diseases and chronic disorders are excluded from the study. According to the order of entry into the study, patients are divided and odd numbers are included in the case group and even numbers are included in the control group. Parents are unaware of the groups. For both groups of interventions, the same general anesthesia is performed according to the anesthesia references. In the patients of the intervention group, the inguinal incision is first opened in the Langer lines of the inguinal canal area. Then the process vaginalis is removed and the necessary parts, including the vas deferens and spermatic blood and lymphatic vessels, are separated from it. The vaginal process is repaired and the patient's hernia is repaired. Then the gubernaculum is cut and hemostasis is done. The vas deferens and the spermatic vessels and the related testicle are preserved. Retro-peritoneum dissection is performed to free the cord so that the testicle reaches the scrotum and sufficient length of the spermatic vessels is created.A tunnel is created on the path of the canal to the scrotum, and the skin of the scrotum is incised, and a pouch is created with a clamp between dartos fascia and scrotal skin. Then with a clamp inserted into the inguinal canal, the testicle is pulled down into the scrotal pouch. The testicle is placed inside the pouch of the dartos fascia. The tunica vaginalis around the testicle is fixed with vicryl absorbable thread in two places, and then dartos is repaired. Then, the oblique external aponeurosis and subcutaneous tissue are repaired. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Individuals can request to receive data and documents at the m.khaaste@gmail.com and the data will be sent after the approval of the university.according to the university guidelines, the data can only be provided to university researchers. There is no limit to data analysis.data must be remain confidential. Any publication of the whole or part of the data requires the permission and approval of the original researcher so that bias does not occur in the data analysis. In case of publication, researcher must cite the owner of the data or article. Where to obtain: Email address: m.khaaste@gmail.com or jamshidim@tbzmed.ac.ir Phone number:989127981446 How to obtain: After registering the application in the email address, the correspondence with the university will be done to get approval and after receiving the approval, the data will be sent.this process will take about one week. Comments:
public Masoud Jamshidi
Zahra Mardani Azari Children hospital, Mardani Azari street, Khavaran town,Tabriz
Tabriz Iran (Islamic Republic of) 5143377505 +98 41 3159 5050 masoudjamshidi@gmail.com Tabriz University of Medical Sciences scientific Masoud Jamshidi
Zahra Mardani Azari Children hospital, Mardani Azari street, Khavaran town,Tabriz
Tabriz Iran (Islamic Republic of) 5143377505 +98 41 3159 5050 masoudjamshidi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with unilateral undescended testicles who have palpable testicles in the inguinal canal. 6 months 24 months Male Non-palpable testis Intra-abdominal testis Absence of testis in preoperative imaging Severely atrophic testis Bilateral undescended testes Associated anomalies with undescended testis Associated genetic anomalies Q53.1 Undescended testicle, unilateral Treatment - Surgery Treatment - Surgery Intervention group:Patients who refer to the children's hospital clinic from the February 2024 until the end of 19th May 2024 are examined first. If there is no testicle in the scrotum unilaterally and the same testicle is touched in the inguinal canal, they are included in the study. Patients with age below six months and age above two years are excluded from the study. For all patients, ultrasound is performed and the findings including the location of the testicles and the dimensions and volume of both testicles are recorded. Patients are admitted and consent to study is obtained from the parents. Patients are examined by attending physician and anesthesiologist. Initial tests include blood cell count is obtained. Patients with concomitant diseases and chronic disorders are excluded from the study. According to the order of entry into the study, patients are divided and odd numbers are included in the intervention group and even numbers are included in the comparison group. Parents are unaware of the groups. For both groups of interventions, the same general anesthesia is performed according to the anesthesia references. In the patients of the intervention group, the inguinal incision is first opened in the Langer lines of the inguinal canal area. Then the process vaginalis is removed and the necessary parts, including the vas deferens and spermatic blood and lymphatic vessels, are separated from it. The vaginal process is repaired and the patient's hernia is repaired. Then the gubernaculum is cut and hemostasis is done. The vas deferens and the spermatic vessels and the related testicle are preserved. Retro-peritoneum dissection is performed to free the cord so that the testicle reaches the scrotum and sufficient length of the spermatic vessels is created. The path of the testicle to the scrotum is opened by the surgeon's finger. Then, without cutting the scrotum, the skin of the scrotum is pulled up to the inguinal incision site by the surgeon's finger guide with a blunt tool. A pouch is formed between the skin of the scrotum and the dartos fascia. The testicle is placed inside poach and fixed to the skin of the scrotum with an absorbable suture. Then the skin along with the testicle is pulled down to the natural place. Then, the oblique external aponeurosis and subcutaneous tissue are repaired. Control group: Patients who refer to the children's hospital clinic from the January 2024 until the end of 19th May 2024 are examined first. If there is no testicle in the scrotum unilaterally and the same testicle is touched in the inguinal canal, they are included in the study. Patients with age below six months and age above two years are excluded from the study. For all patients, ultrasound is performed and the findings including the location of the testicles and the dimensions and volume of both testicles are recorded. Patients are admitted and consent to study is obtained from the parents. Patients are examined by attending physician and anesthesiologist. Initial tests include blood cell count is obtained. Patients with concomitant diseases and chronic disorders are excluded from the study. According to the order of entry into the study, patients are divided and odd numbers are included in the case group and even numbers are included in the control group. Parents are unaware of the groups. For both groups of interventions, the same general anesthesia is performed according to the anesthesia references. In the patients of the intervention group, the inguinal incision is first opened in the Langer lines of the inguinal canal area. Then the process vaginalis is removed and the necessary parts, including the vas deferens and spermatic blood and lymphatic vessels, are separated from it. The vaginal process is repaired and the patient's hernia is repaired. Then the gubernaculum is cut and hemostasis is done. The vas deferens and the spermatic vessels and the related testicle are preserved. Retro-peritoneum dissection is performed to free the cord so that the testicle reaches the scrotum and sufficient length of the spermatic vessels is created.A tunnel is created on the path of the canal to the scrotum, and the skin of the scrotum is incised, and a pouch is created with a clamp between dartos fascia and scrotal skin. Then with a clamp inserted into the inguinal canal, the testicle is pulled down into the scrotal pouch. The testicle is placed inside the pouch of the dartos fascia. The tunica vaginalis around the testicle is fixed with vicryl absorbable thread in two places, and then dartos is repaired. Then, the oblique external aponeurosis and subcutaneous tissue are repaired. Complication rate of undescended testis surgery. Timepoint: One week and one month and three months after surgery. Method of measurement: Observation and ultra-sonography. Tabriz University of Medical Sciences Approved 2023-12-18 Ethics committee of Tabriz Medical University of Medical Sciences Mardani Azari Children hospital, Tabriz, east Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)