An interventional study of Two-Stage GSLO Technique and One-Stage GSLO Technique in Cryptorchidism, sponsored by McMaster University. Recruiting at 1 site in Canada. Open to male participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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.
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.
40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 26 interventional studies indexed under Cryptorchidism.
Browse Cryptorchidism studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages
Procedure: Two-Stage GSLO Technique
Gubernaculum-sparing laparoscopic orchidopexy will be done in a single stage
Procedure: One-Stage GSLO Technique
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.
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.
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.
Time frame: 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.
Time frame: 12 months postoperatively
Recruitment Rate
Will be calculated as the percentage of eligible participants enrolled
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2017 (actual). Primary completion is estimated for Sep 2025, 101 months after the start.
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