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

NCT06558994 | Recruiting

• 1 other identifier: Ahmed Hassan Protocol
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Cryptorchidism

Outcome Measures

Primary Outcomes (2)

• testis-to-ring distance in mm at 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.

  At 6 months after the first stage (during the second stage)

• Testicular volume in mL

  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.

  At 6 months after the first stage (during the second stage)

Secondary Outcomes (1)

• Operative time in minutes

  At 6 months after the first stage (during the second stage)

Study Arms (2)

Transection arm

ACTIVE COMPARATOR

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

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

Ligation arm

ACTIVE COMPARATOR

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

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

Interventions

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.

Transection arm

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

Ligation arm

Eligibility Criteria

• Age: Up to 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients with Unilateral or Bilateral impalpable testis

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Urology Hospital

Asyut, Egypt, 71515, Egypt

RECRUITING

Related Publications (12)

• 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.

  PMID: 17462053 BACKGROUND

• 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.

  PMID: 27521715 BACKGROUND

• 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.

  PMID: 14713841 BACKGROUND

• 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.

  PMID: 28410943 BACKGROUND

• 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.

  PMID: 21075394 BACKGROUND

• 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.

  PMID: 19457721 BACKGROUND

• 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.

  PMID: 17431642 BACKGROUND

• 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.

  PMID: 11298040 BACKGROUND

• 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.

  PMID: 13849840 BACKGROUND

• 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.

  PMID: 17362185 BACKGROUND

• 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.

  PMID: 9692579 BACKGROUND

• 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.

  PMID: 30408514 BACKGROUND

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Mostafa M. Mostafa, MD, MSc, PhD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa M. Mostafa, MD, MSc, PhD

CONTACT

01000740478; mostafaabdelaziz91@gmail.com

Ahmed H. Abolella, MD

CONTACT

01060636273; ahmed.hassan0032@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)