One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy (GSLO) (GSLO)
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|ClinicalTrials.gov Identifier: NCT02936024|
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cryptorchidism||Procedure: Two-Stage GSLO Technique Procedure: One-Stage GSLO Technique||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy: A Randomized Controlled Trial|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Intervention Group: Two-Stage GSLO Technique
Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages
Procedure: Two-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.
Control Group: One-Stage GSLO Technique
Gubernaculum-sparing laparoscopic orchidopexy will be done in a single stage
Procedure: One-Stage GSLO Technique
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 [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936024
|Contact: Luis H Braga, M.D.||905-521-2100 ext email@example.com|
|Contact: Melissa McGrath||905-521-2100 ext firstname.lastname@example.org|
|McMaster Children's Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Contact: Luis Braga, MD 905-521-2100 ext 73777 email@example.com|
|Principal Investigator:||Luis H Braga, M.D.||McMaster University|