CryptorchidismGSLONCT02936024
One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy (GSLO)
A study testing Two-Stage GSLO Technique and One-Stage GSLO Technique in people with Cryptorchidism, run by McMaster University at 1 site in Canada.
Trial summary
Undescended Testis (UDT) is the most common congenital anomaly of the genitalia in boys and it is commonly managed by surgical intervention. Patients with intra-abdominal or non palpable testis, specifically, are often managed using a laparoscopic assisted orchidopexy, a common surgical technique to bring undescended… Read more about this study
- Who is it for?
- Ages 1 year to 5 years, men only
- Conditions the study is for
- Cryptorchidism
- What is being tested?
- Two-Stage GSLO Technique and One-Stage GSLO Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2017to Sep 2025
- 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 1 year to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- boys 1-5 years of age at presentation to Pediatric Urology Clinics
- patients diagnosed with intraabdominal UDT
- patients who require one- or two-stage repair performed by fellowship-trained Pediatric Urologists
Who cannot join
- patients who have undergone previous laparoscopic orchidopexy
- patients with palpable testes
- patients requiring orchiectomy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Luis Braga, MD, 905-521-2100 ext. 73777, braga@mcmaster.ca
About this study
Official title: One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy: A Randomized Controlled Trial
Undescended Testis (UDT) is the most common congenital anomaly of the genitalia in boys and it is commonly managed by surgical intervention. Patients with intra-abdominal or non palpable testis, specifically, are often managed using a laparoscopic assisted orchidopexy, a common surgical technique to bring undescended testes down into the scrotum. Evidence in the medical literature to support the superiority of either one stage or two stage gubernaculum sparing laparoscopic orchidopexy (GSLO) is lacking. Due to this reason, this study focuses on the effects of one stage versus two stage GSLO on a patient important outcome: testicular atrophy.
Read the detailed description
The principal research question to be addressed is: what is the feasibility of a randomized controlled trial to assess whether in boys, 1-5 years of age, diagnosed with intraabdominal UDT, two-stage GSLO results in fewer postoperative testicular atrophies when compared to single-stage GSLO? The results of this study will be used to assess the feasibility of a randomized controlled trial on this topic. If our protocol does not require significant modifications, then participants assessed in this pilot trial will be included as participants in the definitive multicenter trial.
To the best of our knowledge, the full-scale trial will be the first prospective, multicenter, randomized controlled trial to study the success rates of single-stage and two-stage GSLO. The results of the definitive multicenter trial will inform guidelines both locally and nationally, regarding the efficacy of staged techniques for orchidopexy. The results of this study will also inform and improve current care for children with IAT, as atrophy rates can be as high as 33% using the traditional laparoscopic approach.
Furthermore, if it is shown that a single stage approach is more efficacious than a two-stage approach, it will limit unnecessary exposure of young children to general anesthetic, which may be associated with an increased risk for learning disability or behavioral problems
The control group will receive single-stage GSLO procedure, while the intervention group will receive a two-stage GSLO technique. The first stage of the two-stage technique involves the ligation of testicular vessels laparoscopically, or transection of these vessels using cautery. Approximately 3-6 months following the completion of the first stage, the patient is seen again and the second stage of the procedure is performed. Access is obtained with a Hasson technique through an umbilical incision. Dissection begins laterally and proceeds along the superior margin of the internal inguinal ring (IIR), extending medially beyond the obliterated umbilical artery, while preserving a wide strip of peritoneum between the testis and the gubernaculum. Further dissection is then performed proximally, near the bifurcation of the iliac vessels, which allows free mobilization of this peritoneal triangle containing collateral blood supply to the testis. Next, a laparoscopic grasper is advanced through the IIR alongside the gubernaculum, and into the most dependent aspect of the scrotum. The distal gubernacular attachments and preserved cremasteric vessels, along with the testis, are pulled through the IIR with the assistance of a laparoscopic grasper, following the normal testicular descent route into the ipsilateral scrotum. Upon completion of dissection and descent, the testis is fixed to the scrotum in a sub-dartos pouch with a single 4-0 polydioxanone (PDS) stitch. If the patient is randomized to receive single-stage GSLO procedure, it is important to note that both the ligation of testicular vessels and the mobilization of the testis occur during the same operation.
- Conditions
- Cryptorchidism
- Being tested
- Two-Stage GSLO Technique, One-Stage GSLO Technique
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Stage GSLO TechniqueProcedure or surgery
The patient will initially receive the first stage of the two-stage technique which involves the ligation of testicular vessels laparoscopically, or transection of these vessels using cautery. After the first stage is complete, the patient will be seen approximately 3-6 months later for the second stage. The second stage of the procedure involves free mobilization of the testis and placement/fixation of the testicle in the scrotum.
One-Stage GSLO TechniqueProcedure or surgery
The patient will receive only one surgical procedure during which ligation of testicular vessels is performed, as well as mobilization of the testis and placement/fixation of the testicle in the scrotum.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Two-Stage GSLO Technique | Experimental | Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages Receives: Procedure: Two-Stage GSLO Technique |
| Control Group: One-Stage GSLO Technique | Other | Gubernaculum-sparing laparoscopic orchidopexy will be done in a single stage Receives: Procedure: One-Stage GSLO Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Postoperative Testicular Atrophy at 3 Months
How many children have been diagnosed with testicular atrophy 3 months after the surgery has been performed.
Measured: 3 months postoperatively
Rate of Postoperative Testicular Atrophy at 12 Months
How many children have been diagnosed with testicular atrophy 12 months after the surgery has been performed.
Measured: 12 months postoperatively
Recruitment Rate
Will be calculated as the percentage of eligible participants enrolled
Measured: Through study completion, an average of 2 years
Frequency of protocol violations
Will be calculated as the number of protocol violations that occurred during the pilot phase of this trial.
Measured: Through study completion, an average of 2 years
Frequency of adverse events
Will be calculated as the number of documented adverse events during the pilot phase of this trial.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start11 Apr 2017
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptorchidismStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates
- Responsible party
- Sponsor
- Investigators
- Luis H Braga, M.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936024
- Sponsor's protocol ID
- GSLO
- Acronym
- GSLO
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2016
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02936024
- Acronym / sponsor ID
- GSLO / GSLO
- Conditions
- Cryptorchidism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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 Testis (UDT) is the most common congenital anomaly of the genitalia in boys and it is commonly managed by surgical intervention. Patients with intra-abdominal or non palpable testis, specifically, are often managed using a laparoscopic assisted orchidopexy, a common surgical technique to bring undescended testes down into the scrotum. Evidence in the medical literature to support the superiority of either one stage or two stage gubernaculum sparing laparoscopic orchidopexy (GSLO) is lacking. Due to this reason, this study focuses on the effects of one stage versus two stage GSLO on a patient important outcome: testicular atrophy.
Detailed description
The principal research question to be addressed is: what is the feasibility of a randomized controlled trial to assess whether in boys, 1-5 years of age, diagnosed with intraabdominal UDT, two-stage GSLO results in fewer postoperative testicular atrophies when compared to single-stage GSLO? The results of this study will be used to assess the feasibility of a randomized controlled trial on this topic. If our protocol does not require significant modifications, then participants assessed in this pilot trial will be included as participants in the definitive multicenter trial.
To the best of our knowledge, the full-scale trial will be the first prospective, multicenter, randomized controlled trial to study the success rates of single-stage and two-stage GSLO. The results of the definitive multicenter trial will inform guidelines both locally and nationally, regarding the efficacy of staged techniques for orchidopexy. The results of this study will also inform and improve current care for children with IAT, as atrophy rates can be as high as 33% using the traditional laparoscopic approach.
Furthermore, if it is shown that a single stage approach is more efficacious than a two-stage approach, it will limit unnecessary exposure of young children to general anesthetic, which may be associated with an increased risk for learning disability or behavioral problems
The control group will receive single-stage GSLO procedure, while the intervention group will receive a two-stage GSLO technique. The first stage of the two-stage technique involves the ligation of testicular vessels laparoscopically, or transection of these vessels using cautery. Approximately 3-6 months following the completion of the first stage, the patient is seen again and the second stage of the procedure is performed. Access is obtained with a Hasson technique through an umbilical incision. Dissection begins laterally and proceeds along the superior margin of the internal inguinal ring (IIR), extending medially beyond the obliterated umbilical artery, while preserving a wide strip of peritoneum between the testis and the gubernaculum. Further dissection is then performed proximally, near the bifurcation of the iliac vessels, which allows free mobilization of this peritoneal triangle containing collateral blood supply to the testis. Next, a laparoscopic grasper is advanced through the IIR alongside the gubernaculum, and into the most dependent aspect of the scrotum. The distal gubernacular attachments and preserved cremasteric vessels, along with the testis, are pulled through the IIR with the assistance of a laparoscopic grasper, following the normal testicular descent route into the ipsilateral scrotum. Upon completion of dissection and descent, the testis is fixed to the scrotum in a sub-dartos pouch with a single 4-0 polydioxanone (PDS) stitch. If the patient is randomized to receive single-stage GSLO procedure, it is important to note that both the ligation of testicular vessels and the mobilization of the testis occur during the same operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Two-Stage GSLO Technique | Experimental | Procedure: Two-Stage GSLO TechniqueGubernaculum-sparing laparoscopic orchidopexy will be done in two stages |
| Control Group: One-Stage GSLO Technique | Other | Procedure: One-Stage GSLO TechniqueGubernaculum-sparing laparoscopic orchidopexy will be done in a single stage |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- boys 1-5 years of age at presentation to Pediatric Urology Clinics
- patients diagnosed with intraabdominal UDT
- patients who require one- or two-stage repair performed by fellowship-trained Pediatric Urologists
Key exclusion criteria (3 listed)
- patients who have undergone previous laparoscopic orchidopexy
- patients with palpable testes
- patients requiring orchiectomy
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 |
|---|---|---|
| Two-Stage GSLO TechniqueThe patient will initially receive the first stage of the two-stage technique which involves the ligation of testicular vessels laparoscopically, or transection of these vessels using cautery. After the first stage is complete, the patient will be seen approximately 3-6 months later for the second stage. The second stage of the procedure involves free mobilization of the testis and placement/fixation of the testicle in the scrotum. | Procedure or surgery | Intervention Group: Two-Stage GSLO Technique |
| One-Stage GSLO TechniqueThe patient will receive only one surgical procedure during which ligation of testicular vessels is performed, as well as mobilization of the testis and placement/fixation of the testicle in the scrotum. | Procedure or surgery | Control Group: One-Stage GSLO Technique |
Primary outcome
Rate of Postoperative Testicular Atrophy at 3 Months
Time frame: 3 months postoperatively
How many children have been diagnosed with testicular atrophy 3 months after the surgery has been performed.
Rate of Postoperative Testicular Atrophy at 12 Months
Time frame: 12 months postoperatively
How many children have been diagnosed with testicular atrophy 12 months after the surgery has been performed.
Recruitment Rate
Time frame: Through study completion, an average of 2 years
Will be calculated as the percentage of eligible participants enrolled
Frequency of protocol violations
Time frame: Through study completion, an average of 2 years
Will be calculated as the number of protocol violations that occurred during the pilot phase of this trial.
Frequency of adverse events
Time frame: Through study completion, an average of 2 years
Will be calculated as the number of documented adverse events during the pilot phase of this trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Cryptorchidism
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Recruiting
Orchidopexy Randomized Clinical Assessment
Unilateral Cryptorchidism
Recruiting
Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
Cryptorchidism
Recruiting
Comparison of Single Incision Scrotal vs Standard Two Incision Inguinal Orchidopexy in Children Under 10 Years.
Undescended Testis
RecruitingObservational study
Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
Cryptorchidism
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.
Luis H Braga, M.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-Stage GSLO Technique and One-Stage GSLO Technique in people with Cryptorchidism, run by McMaster University at 1 site in Canada.
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 3 inclusion and 3 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 19 Oct 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis H Braga, M.D. (905-521-2100 ext. 73777, braga@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Postoperative Testicular Atrophy at 3 Months (time frame: 3 months postoperatively). The study lists 5 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 19 Oct 2023.