Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Side of affected testis (number of cases)
Study Overview
Brief Summary
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.
- This is a prospective study will be conducted at Department of Pediatric Surgery, MCH hospital, Bisha, Saudia Arabia and Pediatric surgery Department , Al-Azhar University hospitals, Cairo, Egypt, from January 2019 to October 2020 to evaluate the safety and efficiency of laparoscopic orchiopexy of intracanalicular testis.
- Patients' age and laterality will be reported. Evaluation will be done for the operative difficulties, intraoperative complications, operative time and early postoperative complications.
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.
- Laparoscopic orchiopexy for management of inguinal canalicular undescended testes is a safe, effective, and less invasive, without disturbance of inguinal canal anatomy, with better cosmetic results.
Detailed Description
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:
- Different management modalities for intra-canalicular (emergent) testes in male children (open surgery, Laparoscopy).
- Advantages of laparoscopic orchiopexy for intra-canalicular (emergent) testes.
Patients and Methods:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Months to 48 Months (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All children diagnosed as intra-canalicular (emergent/ peeping) testes
Exclusion Criteria
- •Patients above 14 years of age,
- •with retractile testes,
- •with retractile testes that were distal to the external ring and
- •with nonpalpable testes
Outcomes
Primary Outcomes
Side of affected testis (number of cases)
Time Frame: 2 years
The side of the affected testis
Patients' age (in months)
Time Frame: 2 years
Patients' age
Patients' weight (in kilograms)
Time Frame: 2 years
Patients' weight
Secondary Outcomes
- Operative time (in minutes)(1 day (day of surgery))
- Testicular site (in centimeters)(2 years)
- Testicular size (in cubic milliliters)(2 years)
- Parents' satisfaction (percent of each satisfaction grade)(2 years)
- Period of follow-up (in months)(2 years)
Investigators
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine
Al-Azhar University