Viewing Study NCT06558994



Ignite Creation Date: 2024-10-25 @ 7:56 PM
Last Modification Date: 2024-10-26 @ 3:38 PM
Study NCT ID: NCT06558994
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-12

Brief Title: Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
Sponsor: None
Organization: None

Study Overview

Official Title: Transection Versus Ligation of Internal Spermatic Vessels in First Stage Laparoscopic Fowler-Stephens Orchidopexy for Intra-abdominal Testis Randomized Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a comparative study to see the outcome of yransection versus ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis in assisting the descent of the testis to the base of scrotum during the second stage
Detailed Description: Cryptorchidism is one of the most commin congenital deformities of male newborns known as undescended testis UDT The incidence ranges according to gestational age affecting 10-46 of full-term infants and 11-45 of preterm infants UDT is a condition in which the testicles are not found at the base of the scrotum Studies have shown that the undescended testicle has a potential of spontaneous descent during the first 3 months of life and is less likely to do so after 6 months of age In almost 20 of cases the undescended testes are not palpable increasing the difficulty of investigations and treatment and 30 of these cases are also intra-abdominal If UDT left untreated it can cause histological alterations of the testicular cells and increasing of the risks of infertility

As of treatment of UDT laparoscopic surgery is for most surgeons the preferred technique Several techniques have been described for laparoscopic orchidopexy After spermatic vascular transection single-stage testicular descent fixing was carried out as Fowler and Stephens FSO first described in 1959 Since 1996 a two-stage laparoscopic Fowler-Stephens technique involving preservation of the gubernacular vessels and performing an entirely laparoscopic second stage The second stage is presently performed 6-9 months after the first

Recently laparoscopic FSO has been adopted to treat high-level IATs for its minimally invasive wound and acceptable success rate

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None