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

NCT ID: NCT02936024

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2025-09-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group: Two-Stage GSLO Technique

Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages

Group Type: EXPERIMENTAL

Two-Stage GSLO Technique

Intervention Type: PROCEDURE

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

Group Type: OTHER

One-Stage GSLO Technique

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster Surgical Associates

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis H Braga, M.D.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Luis H Braga, M.D.

Role: CONTACT

braga@mcmaster.ca

905-521-2100 ext. 73777

Melissa McGrath

Role: CONTACT

mcgram2@mcmaster.ca

905-521-2100 ext. 73654

Facility Contacts

Luis Braga, MD

Role: primary

braga@mcmaster.ca

905-521-2100 ext. 73777

Other Identifiers

GSLO

Identifier Type: -

Identifier Source: org_study_id