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

Determining the necessity of performing laparoscopic exploration in nonpalpable undescended testis with a cord-like structure on palpation in patients with undescended testis.

In this randomized clinical trial, 40 patients will be randomly divided into intervention and control groups. randomization will be carried out by RAS Software (Random Allocation Software). There will be no blinding in this study.

This study will be performed in the surgery ward of Zahra Mardani Azar Children's Hospital, Tabriz, Iran. Patients referring to Zahra Mardani Azari Children's Hospital clinic will be enrolled. There will be no blinding in this study.

Inclusion criteria: a 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. Exclusion criteria: parents' lack of consent to participate in the study, accompanying anomalies, contraindications for surgery.

Intervention group: open surgery from the beginning (without the use of laparoscopic exploration). In this 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 the priority of laparoscopic exploration over open surgery.

evaluating the percentage of patients who need open surgery after laparoscopic exploration. evaluating the percentage of patients who needed open surgery and underwent open surgery without laparoscopic exploration.

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.

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.

All data related to demographic information, pre-operative findings and post-operative results can be shared after de-identifying individuals.

Data will be available starting 6 months after publication

Data will only be available for people working in academic institutions

Any kind of statistical analysis on the data of this study is allowed if requested by researchers.

Researchers can submit their request via e-mail to the responsible author - Dr. Aslan Abadi - at the address below. aslanabadis@tbzmed.ac.ir

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.