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

Primary Purpose

Testes Undescend

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic orchiopexy for intra-canalicular testis
Sponsored by
dr. Muhammad Abdelhafez Mahmoud, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Testes Undescend focused on measuring Laparoscopic,, orchiopexy,, intracanalicuar testes,, peeping testes

Eligibility Criteria

8 Months - 48 Months (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mohammad Alsayed Daboos

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Patients' age (in months)
Patients' age
Patients' weight (in kilograms)
Patients' weight
Side of affected testis (number of cases)
The side of the affected testis

Secondary Outcome Measures

Operative time (in minutes)
Operative time
Testicular size (in cubic milliliters)
Testicular size measurement by ultrasonography
Testicular site (in centimeters)
Testicular distance from the mid-scrotum point to evaluate that it remained in the scrotum or re-ascended
Parents' satisfaction (percent of each satisfaction grade)
Parents' satisfaction questionnaire
Period of follow-up (in months)
Follow-up period

Full Information

First Posted
March 24, 2021
Last Updated
March 26, 2021
Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04821167
Brief Title
Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis
Acronym
LapUDT
Official Title
Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testes Undescend
Keywords
Laparoscopic,, orchiopexy,, intracanalicuar testes,, peeping testes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective study conducted to evaluate the safety and efficiency of laparoscopic orchiopexy of intra-canalicular (emergent/peeping) testis.
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic orchiopexy for intra-canalicular (emergent or peeping) testis
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic orchiopexy for intra-canalicular testis
Intervention Description
laparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis
Primary Outcome Measure Information:
Title
Patients' age (in months)
Description
Patients' age
Time Frame
2 years
Title
Patients' weight (in kilograms)
Description
Patients' weight
Time Frame
2 years
Title
Side of affected testis (number of cases)
Description
The side of the affected testis
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Operative time (in minutes)
Description
Operative time
Time Frame
1 day (day of surgery)
Title
Testicular size (in cubic milliliters)
Description
Testicular size measurement by ultrasonography
Time Frame
2 years
Title
Testicular site (in centimeters)
Description
Testicular distance from the mid-scrotum point to evaluate that it remained in the scrotum or re-ascended
Time Frame
2 years
Title
Parents' satisfaction (percent of each satisfaction grade)
Description
Parents' satisfaction questionnaire
Time Frame
2 years
Title
Period of follow-up (in months)
Description
Follow-up period
Time Frame
2 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male children with intra-canalicular (emergent/ peeping) testes
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mohammad Alsayed Daboos
City
Cairo
ZIP/Postal Code
11651
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
IPD Sharing Time Frame
October 2020 till indefinitely
IPD Sharing Access Criteria
after the article became accepted and available online.

Learn more about this trial

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

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