An interventional study of laparoscopic orchiopexy for intra-canalicular testis in Testes Undescend, sponsored by dr. Muhammad Abdelhafez Mahmoud, MD. Completed at 1 site in Egypt. Open to male participants aged 8 Months to 48 Months. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by dr. Muhammad Abdelhafez Mahmoud, MD · Not applicable, Interventional, and Treatment
Undescended testes (UDTs) are a relatively common finding in pediatrics with prevalence about 1-2% in newborns. Upon discovering a non-intrascrotal testis, it is important to determine whether the testis is palpable or non-palpable (1). A canalicular or 'emergent' testis may be impalpable initially and may be appear when it is 'milked' out of the inguinal canal (where it is concealed from detection) indicating that 15 to 40% of cryptorchidism are viable peeping/canalicular testis.
The laparoscopic approach for treating canalicular undescended testes offers many advantages over open inguinal orchiopexy. The laparoscopic technique maintains the integrity of the inguinal canal anatomy and eliminating the need to divide the epigastric vessels during dissection. The ability to dissect the testicular vessels at a higher extent would increase the vessel length available to lower the testis without strain.
Testicular site, size and vascularity will be evaluated by ultrasonography at 6th month post operatively. Also, cosmetic results will be evaluated by obtaining the parent's questioners at post-operative OPD clinic visits.
Aim of the study:
Herein, the study aims to evaluate the laparoscopic procedure for management of canalicular testis regarding operative safety, efficacy and post-operative outcomes.
Brief review of literature:
Patients and Methods:
This is a prospective study, will be conducted out at pediatric surgery tertiary centers (Maternity \& Children's Hospital in Bisha, KSA and Al-Azhar University hospitals in Cairo, Egypt) on pediatric patients presenting at the pediatric surgery OPD clinic by intra-canalicular (emergent/peeping) testes in the period from January 2019 to October 2020. Enrolled patients will be managed by laparoscopic orchiopexy. All patients enrolled in the study will give a written informed consent. The study will be approved by the Institutional Review Board and ethics committee of the hospitals. The main objective is to assess safety and efficacy of laparoscopic orchiopexy for intra-canalicular (emergent/peeping) testes in male patients.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Maternity \& Children's hospital in Bisha, KSA and Al-Azhar University hospitals in Cairo.
Number of cases: Sixty two male children. Time frame: period of 1.10 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at MCH at Bisha, KSA, and other participating hospitals. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for laparoscopic management is respected but does not deprive the patient from getting open orchiopexy.
Preoperative preparation:
Proper examination done for patients using flat and frog leg position with gentile squeezing of testis down, proved by preoperative inguinoscrotal ultrasonography.
Follow-up:
Patients will be reviewed at the OPD clinic. Patients who could not attend the clinic will be contacted by phone. Postoperative Doppler ultrasonography will be done to assess testicular size and vascularity. Questionnaire will be obtained from the parents to assess their cosmetic satisfaction.
Statistical analysis:
It will be performed with IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp. Data will be presented as mean, standard deviation, number \& percentage, using Chi-squared test (X2) for qualitative data. The significance level will be set at P > 0.05.
It will compare results of this study with the results of others. Discussion will determine the most accurate management modality for intra-canalicular (emergent) testes in male children which offers the best outcome and least morbidity.
40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 26 interventional studies indexed under Cryptorchidism.
Browse Cryptorchidism studies →dr. Muhammad Abdelhafez Mahmoud, MD is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
This is a prospective study conducted on male children with intermittent palpable (peeping) UDT to evaluate the safety and efficiency of laparoscopic orchiopexy of intra-canalicular (emergent or peeping) testis.
Procedure: laparoscopic orchiopexy for intra-canalicular testis
laparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis
Patients' age (in months)
Patients' age
Time frame: 2 years
Patients' weight (in kilograms)
Patients' weight
Time frame: 2 years
Side of affected testis (number of cases)
The side of the affected testis
Time frame: 2 years
Operative time (in minutes)
Operative time
Time frame: 1 day (day of surgery)
Testicular size (in cubic milliliters)
Testicular size measurement by ultrasonography
Time frame: 2 years
Testicular site (in centimeters)
Testicular distance from the mid-scrotum point to evaluate that it remained in the scrotum or re-ascended
Time frame: 2 years
Parents' satisfaction (percent of each satisfaction grade)
Parents' satisfaction questionnaire
Time frame: 2 years
Period of follow-up (in months)
Follow-up period
Time frame: 2 years
Plan to share: Yes — Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: October 2020 till indefinitely
Access criteria: after the article became accepted and available online.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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dr. Muhammad Abdelhafez Mahmoud, MD