Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis

NCT04821167 | Completed DMC

• 1 other identifier: Al-AzharLapUDT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Testes Undescend

Keywords

Laparoscopic,; orchiopexy,; intracanalicuar testes,; peeping testes

Outcome Measures

Primary Outcomes (3)

• Patients' age (in months)

  Patients' age

  2 years

• Patients' weight (in kilograms)

  Patients' weight

  2 years

• Side of affected testis (number of cases)

  The side of the affected testis

  2 years

Secondary Outcomes (5)

• Operative time (in minutes)

  1 day (day of surgery)

• Testicular size (in cubic milliliters)

  2 years

• Testicular site (in centimeters)

  2 years

• Parents' satisfaction (percent of each satisfaction grade)

  2 years

• Period of follow-up (in months)

  2 years

Study Arms (1)

Laparoscopic orchiopexy for intra-canalicular (emergent or peeping) testis

OTHER

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

Interventions

laparoscopic orchiopexy for intra-canalicular testis PROCEDURE

laparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis

Laparoscopic orchiopexy for intra-canalicular (emergent or peeping) testis

Eligibility Criteria

• Age: 8 Months - 48 Months
• Gender Eligibility Details: Male children with intra-canalicular (emergent/ peeping) testes
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children diagnosed as intra-canalicular (emergent/ peeping) testes

You may not qualify if:

• Patients above 14 years of age,
• with retractile testes,
• with retractile testes that were distal to the external ring and
• with nonpalpable testes

Sponsors & Collaborators

• dr. Muhammad Abdelhafez Mahmoud, MD: lead

Study Sites (1)

Mohammad Alsayed Daboos

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Cryptorchidism

Interventions

Orchiopexy

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine

Model Details: This is a prospective study conducted to evaluate the safety and efficiency of laparoscopic orchiopexy of intra-canalicular (emergent/peeping) testis.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: January 1, 2019
• Primary Completion: April 20, 2020
• Study Completion: October 31, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: October 2020 till indefinitely
• Access Criteria: after the article became accepted and available online.

Locations

EG (1)