Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06558994

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Urology Hospital

Asyut, Egypt, 71515

Location status: Recruiting

Location contact

Mostafa M. Mostafa, M.D., M.Sc., Ph.D.

CONTACT

[email protected]

+201000740478

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients with Unilateral or Bilateral impalpable testis

Exclusion criteria

  • Previous Laparotomy surgery
  • Previous Ventriculo-peritoneal shunt
  • Previous laparoscopy for impalpable testis (outside study)
  • Previous Inguinal/Scrotal surgery
  • Disorder of sexual differentiation
  • Abnormal Karyotyping
  • Intra-operative Inguinal testis
  • Ipsilateral testis : Peeping/ Vas internal internal ring / Vanished / Streak / Ovotestis / Ovary.
  • Contralateral : Streak/ Ovotestis/ Ovary

Treatment and study plan

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

Procedure

Half of the patients will undergo 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

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

Primary outcomes

  1. testis-to-ring distance in mm at the second stage

    Time frame: At 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.

  2. Testicular volume in mL

    Time frame: At 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 outcomes

  1. Operative time in minutes

    Time frame: At 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed H. Abolella, MD

CONTACT

[email protected]

01060636273 ext. +2

Mostafa M. Mostafa, MD, MSc, PhD

CONTACT

[email protected]

01000740478 ext. +2

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.