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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy: A Randomized Controlled Trial

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.

Detailed Summary:
Sponsor: McMaster University

Current 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.

Original Primary Outcome:

• Rate of Postoperative Testicular Atrophy at 3 Months [ Time Frame: 3 months postoperatively ]
• Rate of Postoperative Testicular Atrophy at 12 Months [ Time Frame: 12 months postoperatively ]
• 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 ]
• Frequency of adverse events [ Time Frame: Through study completion, an average of 2 years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: McMaster University

Dates:
Date Received: October 7, 2016
Date Started: July 2017
Date Completion: January 2019
Last Updated: March 21, 2017
Last Verified: March 2017