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Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy

Transection Versus Ligation of Internal Spermatic Vessels in First Stage Laparoscopic Fowler-Stephens Orchidopexy for Intra-abdominal Testis. Randomized Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558994
Enrollment
58
Registered
2024-08-19
Start date
2024-09-01
Completion date
2027-09-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptorchidism

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 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.

Interventions

PROCEDURETransection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis

Half of the patients will undergo transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis.

PROCEDURELigation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis

Half of the patients will undergo ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
No minimum to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
testis-to-ring distance in mm at the second stageAt 6 months after the first stage (during the second stage)After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the location of the testis away from the internal inguinal ring (the testis-to-ring distance in mm) will be measured during the 2nd stage (degree of descent) 6 months after the first stage and compared among the two groups.
Testicular volume in mLAt 6 months after the first stage (during the second stage)After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the testicular volume in mL will be assessed intraoperatively during the second stage (6 months after the first stage) and compared among the two groups.

Secondary

MeasureTime frameDescription
Operative time in minutesAt 6 months after the first stage (during the second stage)After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the operative time in minutes of the second stage will be measured and compared among the two groups.

Countries

Egypt

Contacts

CONTACTMostafa M. Mostafa, MD, MSc, PhD
mostafaabdelaziz91@gmail.com01000740478
CONTACTAhmed H. Abolella, MD
ahmed.hassan0032@med.aun.edu.eg01060636273
PRINCIPAL_INVESTIGATORMostafa M. Mostafa, MD, MSc, PhD

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026