CryptorchidismNCT06558994
Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
A study testing Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis and Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis in people with Cryptorchidism, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 12 years, men only
- Conditions the study is for
- Cryptorchidism
- What is being tested?
- Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis and Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- All patients with Unilateral or Bilateral impalpable testis
Who cannot join
- Previous Laparotomy surgery
- Previous Ventriculo-peritoneal shunt
- Previous laparoscopy for impalpable testis (outside study)
- Previous Inguinal/Scrotal surgery
- Disorder of sexual differentiation
- Abnormal Karyotyping
Show all 9Show fewer
- Intra-operative Inguinal testis
- Ipsilateral testis : Peeping/ Vas internal internal ring / Vanished / Streak / Ovotestis / Ovary.
- Contralateral : Streak/ Ovotestis/ Ovary
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Urology Hospital
Asyut, Egypt, 71515
Mostafa M. Mostafa, M.D., M.Sc., Ph.D., +201000740478, mostafaabdelaziz91@gmail.com
About this study
Official title: Transection Versus Ligation of Internal Spermatic Vessels in First Stage Laparoscopic Fowler-Stephens Orchidopexy for Intra-abdominal Testis. Randomized Study
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
Read the 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.
- Conditions
- Cryptorchidism
- Being tested
- 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
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testisProcedure or surgery
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 testisProcedure or surgery
Half of the patients will undergo ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis
| Study group | Role | What they receive |
|---|---|---|
| Transection arm | Active comparator | Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis Receives: 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 Receives: Procedure: Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 6 months after the first stage (during the second stage)
Secondary outcomes (1)
Operative time in minutes
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.
Measured: At 6 months after the first stage (during the second stage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for CryptorchidismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Atef Abdelaziz Mostafa, Assiut University
- Investigators
- Mostafa M. Mostafa, MD, MSc, PhD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558994
- Sponsor's protocol ID
- Ahmed Hassan Protocol
- Status last verified
- Feb 2026
- First submitted
- 12 Aug 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to protect privacy of patients
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.
PubMed 17462053Vikraman 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.
PubMed 27521715Wenzler 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.
PubMed 14713841Wang 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.
PubMed 28410943AbouZeid 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.
PubMed 21075394Hvistendahl 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.
PubMed 19457721Murphy 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.
PubMed 17431642Chang 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.
PubMed 11298040FOWLER 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.
PubMed 13849840Robertson 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.
PubMed 17362185Humphrey 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.
PubMed 9692579Yu 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.
PubMed 30408514
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transection Versus Ligation of Internal Spermatic Vessels in First Stage Laparoscopic Fowler-Stephens Orchidopexy for Intra-abdominal Testis. Randomized Study
- ClinicalTrials.gov ID
- NCT06558994
- Acronym / sponsor ID
- Ahmed Hassan Protocol
- Conditions
- Cryptorchidism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transection arm | Active comparator | Procedure: Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testisTransection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis |
| Ligation arm | Active comparator | Procedure: Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testisligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis |
Who may qualify
- Ages
- Up to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients with Unilateral or Bilateral impalpable testis
Key exclusion criteria (9 listed)
- Previous Laparotomy surgery
- Previous Ventriculo-peritoneal shunt
- Previous laparoscopy for impalpable testis (outside study)
- Previous Inguinal/Scrotal surgery
- Disorder of sexual differentiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testisHalf of the patients will undergo transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis. | Procedure or surgery | Transection arm |
| Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testisHalf of the patients will undergo ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis | Procedure or surgery | Ligation arm |
Primary outcome
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.
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.
1 secondary outcome
Operative time in minutes
Time frame: At 6 months after the first stage (during the second stage)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 17462053Virtanen 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.
- Background: PubMed 27521715Vikraman 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.
- Background: PubMed 14713841Wenzler 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.
- Background: PubMed 28410943Wang 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.
- Background: PubMed 21075394AbouZeid 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.
- Background: PubMed 19457721Hvistendahl 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.
- Background: PubMed 17431642Murphy 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.
- Background: PubMed 11298040Chang 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.
- Background: PubMed 13849840FOWLER 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.
- Background: PubMed 17362185Robertson 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.
- Background: PubMed 9692579Humphrey 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.
- Background: PubMed 30408514Yu 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to protect privacy of patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa M. Mostafa, MD, MSc, PhD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis and Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis in people with Cryptorchidism, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M. Mostafa, MD, MSc, PhD (01000740478 ext. +2, mostafaabdelaziz91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
testis-to-ring distance in mm at the second stage (time frame: At 6 months after the first stage (during the second stage)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558994, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.