RECRUITING

Orchidopexy Randomized Clinical Assessment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. Also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. Testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery).

Official Title

Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis

Quick Facts

Study Start:2014-08
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02235623

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Months to 36 Months
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Boys age 4 months to 36 months
  2. * Undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at laparoscopy to have an abdominal undescended testis, in whom a Fowler-Stephens Orchiopexy would be appropriate.
  1. * Age \> 36 months
  2. * Age \< 4 months
  3. * Bilateral cryptorchidism
  4. * Solitary testis
  5. * Findings at laparoscopy for which Fowler-Stephens Orchiopexy would not be indicated
  6. * Intra-operative mobility of the intra-abdominal testis such that, with no (or minimal) mobilization, the testis is able to reach the contralateral internal ring, without dividing the spermatic vessels.
  7. * Assessment of whether a single stage primary orchidopexy will be performed, is entirely at the discretion of the attending surgeon.

Contacts and Locations

Study Contact

Badar Omar, BA
CONTACT
617-919-6352
Badar.Omar@childrens.harvard.edu

Principal Investigator

Caleb P Nelson, MD, MPH
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Caleb P Nelson, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-08
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2014-08
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Laparoscopic Surgery
  • Orchiopexy

Additional Relevant MeSH Terms

  • Unilateral Cryptorchidism