- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821167
Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis (LapUDT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
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.
- Discussion will focus on laparoscopic management of intra-canalicular (emergent) testes. The results obtained from this study will be compared with each other and with that reported in the literature. The discussion will focus on operative details, operative time, results, & complications.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 11651
- Mohammad Alsayed Daboos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Laparoscopic orchiopexy for intra-canalicular (emergent or peeping) testis
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.
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laparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' age (in months)
Time Frame: 2 years
|
Patients' age
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2 years
|
Patients' weight (in kilograms)
Time Frame: 2 years
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Patients' weight
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2 years
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Side of affected testis (number of cases)
Time Frame: 2 years
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The side of the affected testis
|
2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time (in minutes)
Time Frame: 1 day (day of surgery)
|
Operative time
|
1 day (day of surgery)
|
Testicular size (in cubic milliliters)
Time Frame: 2 years
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Testicular size measurement by ultrasonography
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2 years
|
Testicular site (in centimeters)
Time Frame: 2 years
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Testicular distance from the mid-scrotum point to evaluate that it remained in the scrotum or re-ascended
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2 years
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Parents' satisfaction (percent of each satisfaction grade)
Time Frame: 2 years
|
Parents' satisfaction questionnaire
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2 years
|
Period of follow-up (in months)
Time Frame: 2 years
|
Follow-up period
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2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Al-AzharLapUDT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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