We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High InguinaPhase 4NCT05845515
Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
A Phase 4 study testing laparoscopic orchiopexy in people with We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina, run by South Valley University at 1 site in Egypt.
Trial summary
We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal. All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study. Read more about this study
- Who is it for?
- Ages 6 months to 12 years, men only
- Conditions the study is for
- We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina
- What is being tested?
- laparoscopic orchiopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jun 2023
- Phase
- Phase 4
- 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 6 months to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- all children presented with high inguinal undescended testis
Who cannot join
- previous inguinal surgery
- unfit patients
Trial locations and contacts
1 site in 1 country.
About this study
We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.
All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.
Read more
We exclude children with previous history of inguinal surgery or unfit for anesthesia.
150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.
All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal \& colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.
Read the detailed description
Cryptorchidism, or undescended testis, is a common congenital anomaly in male child, it accounts 1 to 4.6% of full-term infants at the age of 1 year.
This condition usually involves the testicle that fail to travel from the abdomen through the inguinal canal to the scrotum during fetal life., cryptorchidism usually classified as inguinal cryptorchidism and intra-abdominal cryptorchidism in clinical practice, about 80% of undescended testis can feel the testis in the inguinal canal (1).
Cryptorchidism more than 6 months needs orchiopexy. Although laparoscopy has used widely in management of intra-abdominal cryptorchidism, there were controversy for its use in the treatment of inguinal cryptorchidism (1).
Open surgical treatment of such high inguinal testes is the most popular approach among urologists. Due to the difficult surgical mobilization of some high inguinal testes, as well as significant complications, including testicular retraction/atrophy (3-18%), we hypothesized in this study that laparoscopic orchiopexy for such high inguinal testes will be an attractive alternative approach (2).
Patients and methods
We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.
All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.
We exclude children with previous history of inguinal surgery or unfit for anesthesia.
150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.
All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal \& colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.
- Being tested
- laparoscopic orchiopexy
- Keywords
- laparoscopy , open , orchiopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic orchiopexyProcedure or surgery
laparoscopic or open orchiopexy and comparison between the two groups
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic orchiopexy | Active comparator | laparoscopic orchiopexy group Receives: Procedure: laparoscopic orchiopexy |
| open orchiopexy | Active comparator | open orchiopexy group Receives: Procedure: laparoscopic orchiopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of laparoscopy and open surgery in treatment of high inguinal testis
assess the outcome and success rate of laparoscopy and open surgery in treatment of high inguinal testis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jan 2018
- Primary completion15 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High InguinaStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa AbdelRazek, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845515
- Sponsor's protocol ID
- SVU/MED/URO016/1.21.4.184
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05845515
- Acronym / sponsor ID
- SVU/MED/URO016/1.21.4.184
- Keywords
- laparoscopy , open , orchiopexy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 6 May 2023 (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.
We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.
All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.
We exclude children with previous history of inguinal surgery or unfit for anesthesia.
150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.
All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal \& colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.
Detailed description
Cryptorchidism, or undescended testis, is a common congenital anomaly in male child, it accounts 1 to 4.6% of full-term infants at the age of 1 year.
This condition usually involves the testicle that fail to travel from the abdomen through the inguinal canal to the scrotum during fetal life., cryptorchidism usually classified as inguinal cryptorchidism and intra-abdominal cryptorchidism in clinical practice, about 80% of undescended testis can feel the testis in the inguinal canal (1).
Cryptorchidism more than 6 months needs orchiopexy. Although laparoscopy has used widely in management of intra-abdominal cryptorchidism, there were controversy for its use in the treatment of inguinal cryptorchidism (1).
Open surgical treatment of such high inguinal testes is the most popular approach among urologists. Due to the difficult surgical mobilization of some high inguinal testes, as well as significant complications, including testicular retraction/atrophy (3-18%), we hypothesized in this study that laparoscopic orchiopexy for such high inguinal testes will be an attractive alternative approach (2).
Patients and methods
We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.
All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.
We exclude children with previous history of inguinal surgery or unfit for anesthesia.
150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.
All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal \& colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic orchiopexy | Active comparator | Procedure: laparoscopic orchiopexylaparoscopic orchiopexy group |
| open orchiopexy | Active comparator | Procedure: laparoscopic orchiopexyopen orchiopexy group |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all children presented with high inguinal undescended testis
Key exclusion criteria (2 listed)
- previous inguinal surgery
- unfit patients
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 orchiopexylaparoscopic or open orchiopexy and comparison between the two groups | Procedure or surgery | laparoscopic orchiopexy, open orchiopexy |
Primary outcome
success of laparoscopy and open surgery in treatment of high inguinal testis
Time frame: 5 years
assess the outcome and success rate of laparoscopy and open surgery in treatment of high inguinal testis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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 Phase 4 study testing laparoscopic orchiopexy in people with We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina, run by South Valley University 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 2 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
success of laparoscopy and open surgery in treatment of high inguinal testis (time frame: 5 years). 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 6 May 2023.