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

NCT ID: NCT06558994

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cryptorchidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transection arm

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Ligation arm

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transection 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.

Intervention Type PROCEDURE

Ligation 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mostafa Mohamed Atef Abdelaziz Mostafa

Lecturer of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mostafa M. Mostafa, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University Urology Hospital

Asyut, Egypt, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mostafa M. Mostafa, MD, MSc, PhD

Role: CONTACT

01000740478 ext. +2

Ahmed H. Abolella, MD

Role: CONTACT

01060636273 ext. +2

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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

Role: primary

+201000740478

References

Explore related publications, articles, or registry entries linked to this study.

Virtanen HE, Bjerknes R, Cortes D, Jorgensen N, Rajpert-De Meyts E, Thorsson AV, Thorup J, Main KM. Cryptorchidism: classification, prevalence and long-term consequences. Acta Paediatr. 2007 May;96(5):611-6. doi: 10.1111/j.1651-2227.2007.00241.x.

Reference Type BACKGROUND
PMID: 17462053 (View on PubMed)

Vikraman J, Hutson JM, Li R, Thorup J. The undescended testis: Clinical management and scientific advances. Semin Pediatr Surg. 2016 Aug;25(4):241-8. doi: 10.1053/j.sempedsurg.2016.05.007. Epub 2016 May 11.

Reference Type BACKGROUND
PMID: 27521715 (View on PubMed)

Wenzler DL, Bloom DA, Park JM. What is the rate of spontaneous testicular descent in infants with cryptorchidism? J Urol. 2004 Feb;171(2 Pt 1):849-51. doi: 10.1097/01.ju.0000106100.21225.d7.

Reference Type BACKGROUND
PMID: 14713841 (View on PubMed)

Wang CY, Wang Y, Chen XH, Wei XY, Chen F, Zhong M. Efficacy of single-stage and two-stage Fowler-Stephens laparoscopic orchidopexy in the treatment of intraabdominal high testis. Asian J Surg. 2017 Nov;40(6):490-494. doi: 10.1016/j.asjsur.2016.11.008. Epub 2017 Apr 12.

Reference Type BACKGROUND
PMID: 28410943 (View on PubMed)

AbouZeid AA, Mousa MH, Soliman HA, Hamza AF, Hay SA. Intra-abdominal testis: histological alterations and significance of biopsy. J Urol. 2011 Jan;185(1):269-74. doi: 10.1016/j.juro.2010.09.026.

Reference Type BACKGROUND
PMID: 21075394 (View on PubMed)

Hvistendahl GM, Poulsen EU. Laparoscopy for the impalpable testes: experience with 80 intra-abdominal testes. J Pediatr Urol. 2009 Oct;5(5):389-92. doi: 10.1016/j.jpurol.2009.04.004. Epub 2009 May 19.

Reference Type BACKGROUND
PMID: 19457721 (View on PubMed)

Murphy F, Paran TS, Puri P. Orchidopexy and its impact on fertility. Pediatr Surg Int. 2007 Jul;23(7):625-32. doi: 10.1007/s00383-007-1900-3. Epub 2007 Mar 13.

Reference Type BACKGROUND
PMID: 17431642 (View on PubMed)

Chang B, Palmer LS, Franco I. Laparoscopic orchidopexy: a review of a large clinical series. BJU Int. 2001 Apr;87(6):490-3. doi: 10.1046/j.1464-410x.2001.00100.x.

Reference Type BACKGROUND
PMID: 11298040 (View on PubMed)

FOWLER R, STEPHENS FD. The role of testicular vascular anatomy in the salvage of high undescended testes. Aust N Z J Surg. 1959 Aug;29:92-106. doi: 10.1111/j.1445-2197.1959.tb03826.x. No abstract available.

Reference Type BACKGROUND
PMID: 13849840 (View on PubMed)

Robertson SA, Munro FD, Mackinlay GA. Two-stage Fowler-Stephens orchidopexy preserving the gubernacular vessels and a purely laparoscopic second stage. J Laparoendosc Adv Surg Tech A. 2007 Feb;17(1):101-7. doi: 10.1089/lap.2006.0565.

Reference Type BACKGROUND
PMID: 17362185 (View on PubMed)

Humphrey GM, Najmaldin AS, Thomas DF. Laparoscopy in the management of the impalpable undescended testis. Br J Surg. 1998 Jul;85(7):983-5. doi: 10.1046/j.1365-2168.1998.00748.x.

Reference Type BACKGROUND
PMID: 9692579 (View on PubMed)

Yu C, Long C, Wei Y, Tang X, Liu B, Shen L, Dong X, Lin T, He D, Wu S, Wei G. Evaluation of Fowler-Stephens orchiopexy for high-level intra-abdominal cryptorchidism: A systematic review and meta-analysis. Int J Surg. 2018 Dec;60:74-87. doi: 10.1016/j.ijsu.2018.10.046. Epub 2018 Nov 5.

Reference Type BACKGROUND
PMID: 30408514 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ahmed Hassan Protocol

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Distal Hypospadias Repair Outcome
NCT06700629 NOT_YET_RECRUITING NA