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

Official title

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

Overview

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

• Procedure 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.
• 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

Primary outcome measures

• testis-to-ring distance in mm at the second stage [Time frame: At 6 months after the first stage (during the second stage)]
• Testicular volume in mL [Time frame: At 6 months after the first stage (during the second stage)]

Secondary outcome measures (1)

• Operative time in minutes [Time frame: At 6 months after the first stage (during the second stage)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Assiut University Urology Hospital — Asyut

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06558994 · Ahmed Hassan Protocol

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗