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IRCT20231217060442N1 IRCT 2024-02-13 Tabriz University of Medical Sciences Requirement to open surgery in patients with nonpalpable undescended testis, with cord-like structure on palpation Comparison of inguinal exploration and laparoscopic exploration of nonpalpable undescended testis with cord-like structure on palpation, on requirement to open surgery procedure in patients with undescended testis 2024-01-05 anticipated 40 Complete https://irct.ir/trial/74516 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. After entering the clinic and meeting the inclusion criteria, the patients will receive a random number that is generated by a calculator instantly and is multiplied by the sample size. If the number is odd, the patient will be included in the intervention group, and if the number is even, the patient will be included in the control group, Blinding description: In this study, double blinding will be used. Double blind: 1- Patients (participants) will be divided into two groups according to the table of random numbers after meeting the conditions of the study and obtaining consent. The parents of the patients will not be involved in determining the type of treatment. 2- The research physician who provides the intervention will not be aware of how the groups will be assigned to the intervention and control. N/A nonpalpable undescended testis with cord-like structure on palpation. Intervention 1: Intervention group: patients who undergo open surgery from the beginning, despite the standard treatment process with initial. In the intervention group, the inguinal area will be explored in an open form from the beginning, and if the cord elements pass through the inner ring of the inguinal canal into the canal, after the anatomical correction, the surgery will be terminated. Intervention 2: Control group: conventional procedure of concurrent laparoscopic exploration and open surgery. Yes - There is a plan to make this available What will be shared: All data related to demographic information, pre-operative findings and post-operative results can be shared after de-identifying individuals. When: Data will be available starting 6 months after publication To whom: Data will only be available for people working in academic institutions Conditions: Any kind of statistical analysis on the data of this study is allowed if requested by researchers. Where to obtain: Researchers can submit their request via e-mail to the responsible author - Dr. Aslan Abadi - at the address below. aslanabadis@tbzmed.ac.ir How to obtain: After sending the requested email and explaining the study that the researcher wants to do, and if approved by the responsible author, the data will be available to her after one week. Comments:
public Saeed Aslanabadi
Tabriz University of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166615731 +98 914 404 5349 aslanabadis@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Vahid Hamzei
Tabriz University of Medical Sciences; Golgasht street
Tabriz Iran (Islamic Republic of) 5166615731 +98 41 3638 8728 vahid1hamzei@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of undescended testis (UDT) by a pediatric surgeon and indication for surgery Minimum age of 12 years Absence of inguinal region anomaly Palpation of cord-like structure in examination by two pediatric surgeons no limit 12 years Male Parents' lack of consent to participate in the study Accompanying anomalies Contraindications for surgery Q53.9 Undescended testicle, unspecified Treatment - Surgery Treatment - Surgery Intervention group: patients who undergo open surgery from the beginning, despite the standard treatment process with initial. In the intervention group, the inguinal area will be explored in an open form from the beginning, and if the cord elements pass through the inner ring of the inguinal canal into the canal, after the anatomical correction, the surgery will be terminated. Control group: conventional procedure of concurrent laparoscopic exploration and open surgery The percentage of patients who need open surgery after laparoscopic exploration. Timepoint: immediately during surgery. Method of measurement: Counting the number of patients who require reoperation despite the initial laparoscopic examination. The percentage of patients who needed open surgery and underwent open surgery without laparoscopic exploration. Timepoint: immediately during surgery. Method of measurement: Counting the number of patients who needed open surgery and underwent open surgery without laparoscopic exploration. Tabriz University of Medical Sciences Approved 2023-12-09 Ethics committee of Tabriz University of Medical Sciences Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)