Transection Versus Ligation of Internal Spermatic Vessels in First Stage Laparoscopic Fowler-Stephens Orchidopexy for Intra-abdominal Testis. Randomized Study
| Registry | NCT06558994 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 58 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Cryptorchidism |
| Interventions | Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis, Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis (Procedure) |
| Dates | start 2024-09-01, primary completion 2027-06-01 (estimated), completion 2027-09-01 (estimated), first posted 2024-08-19, last updated 2026-02-12 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Cryptorchidism All trials of Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis All trials of Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis
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
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 1.0-4.6% of full-term infants and 1.1-45% 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Transection arm | Active comparator | Procedure: Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis | Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis |
| Ligation arm | Active comparator | Procedure: Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis | ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis |
Sex: Male, ages: any to 12 Years
Inclusion Criteria: All patients with Unilateral or Bilateral impalpable testis Exclusion Criteria: 1. Previous Laparotomy surgery 2. Previous Ventriculo-peritoneal shunt 3. Previous laparoscopy for impalpable testis (outside study) 4. Previous Inguinal/Scrotal surgery 5. Disorder of sexual differentiation 6. Abnormal Karyotyping 7. Intra-operative Inguinal testis 8. Ipsilateral testis : Peeping/ Vas internal internal ring / Vanished / Streak / Ovotestis / Ovary. 9. Contralateral : Streak/ Ovotestis/ Ovary
| Facility | City | Country | Status |
|---|---|---|---|
| Assiut University Urology Hospital | Asyut, Egypt | Egypt | Recruiting |