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One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy (GSLO) (GSLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02936024
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
McMaster Surgical Associates
Information provided by (Responsible Party):
McMaster University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Cryptorchidism Procedure: Two-Stage GSLO Technique Procedure: One-Stage GSLO Technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Recruitment Rate [ Time Frame: Through study completion, an average of 2 years ]
    Will be calculated as the percentage of eligible participants enrolled

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients who have undergone previous laparoscopic orchidopexy
  • patients with palpable testes
  • patients requiring orchiectomy

Information from the National Library of Medicine

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


Contacts
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Contact: Luis H Braga, M.D. 905-521-2100 ext 73777 braga@mcmaster.ca
Contact: Melissa McGrath 905-521-2100 ext 73654 mcgram2@mcmaster.ca

Locations
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Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Luis Braga, MD    905-521-2100 ext 73777    braga@mcmaster.ca   
Sponsors and Collaborators
McMaster University
McMaster Surgical Associates
Investigators
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Principal Investigator: Luis H Braga, M.D. McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02936024    
Other Study ID Numbers: GSLO
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cryptorchidism
Testicular Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases