Testes UndescendLapUDTNCT04821167
Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis
A study testing laparoscopic orchiopexy for intra-canalicular testis in people with Testes Undescend, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 48 months, men only
- Conditions the study is for
- Testes Undescend
- What is being tested?
- laparoscopic orchiopexy for intra-canalicular testis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 48 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- All children diagnosed as intra-canalicular (emergent/ peeping) testes
Who cannot join
- Patients above 14 years of age,
- with retractile testes,
- with retractile testes that were distal to the external ring and
- with nonpalpable testes
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
- 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.
Read the 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.
- Conditions
- Testes Undescend
- Being tested
- laparoscopic orchiopexy for intra-canalicular testis
- Keywords
- Laparoscopic,, orchiopexy,, intracanalicuar testes,, peeping testes
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic orchiopexy for intra-canalicular testisProcedure or surgery
laparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: laparoscopic orchiopexy for intra-canalicular testis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' age (in months)
Patients' age
Measured: 2 years
Patients' weight (in kilograms)
Patients' weight
Measured: 2 years
Side of affected testis (number of cases)
The side of the affected testis
Measured: 2 years
Secondary outcomes (5)
Operative time (in minutes)
Operative time
Measured: 1 day (day of surgery)
Testicular size (in cubic milliliters)
Testicular size measurement by ultrasonography
Measured: 2 years
Testicular site (in centimeters)
Testicular distance from the mid-scrotum point to evaluate that it remained in the scrotum or re-ascended
Measured: 2 years
Parents' satisfaction (percent of each satisfaction grade)
Parents' satisfaction questionnaire
Measured: 2 years
Period of follow-up (in months)
Follow-up period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Jan 2019
- Primary completion20 Apr 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testes UndescendStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Muhammad Abdelhafez Mahmoud, MD, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821167
- Sponsor's protocol ID
- Al-AzharLapUDT
- Acronym
- LapUDT
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis
- ClinicalTrials.gov ID
- NCT04821167
- Acronym / sponsor ID
- LapUDT / Al-AzharLapUDT
- Conditions
- Testes Undescend
- Keywords
- Laparoscopic,, orchiopexy,, intracanalicuar testes,, peeping testes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective study conducted to evaluate the safety and efficiency of laparoscopic orchiopexy of intra-canalicular (emergent/peeping) testis.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic orchiopexy for intra-canalicular (emergent or peeping) testis | Other | Procedure: laparoscopic orchiopexy for intra-canalicular testisThis 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. |
Who may qualify
- Ages
- 8 to 48 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children diagnosed as intra-canalicular (emergent/ peeping) testes
Key exclusion criteria (4 listed)
- Patients above 14 years of age,
- with retractile testes,
- with retractile testes that were distal to the external ring and
- with nonpalpable testes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic orchiopexy for intra-canalicular testislaparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis | Procedure or surgery | Laparoscopic orchiopexy for intra-canalicular (emergent or peeping) testis |
Primary outcome
Patients' age (in months)
Time frame: 2 years
Patients' age
Patients' weight (in kilograms)
Time frame: 2 years
Patients' weight
Side of affected testis (number of cases)
Time frame: 2 years
The side of the affected testis
5 secondary outcomes
Operative time (in minutes)
Time frame: 1 day (day of surgery)
Testicular size (in cubic milliliters)
Time frame: 2 years
Testicular site (in centimeters)
Time frame: 2 years
Parents' satisfaction (percent of each satisfaction grade)
Time frame: 2 years
Period of follow-up (in months)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: 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
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Orchidopexy Randomized Clinical Assessment
Unilateral Cryptorchidism
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Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
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Comparison of Single Incision Scrotal vs Standard Two Incision Inguinal Orchidopexy in Children Under 10 Years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic orchiopexy for intra-canalicular testis in people with Testes Undescend, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' age (in months) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.