Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407903425146 Date of Registration: 31/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Analysis of Fowler-Stephens versus Shehata Surgical Techniques in the Management of High Intra-Abdominal Testes in Pediatric Patients, A pilot study
Official scientific title Comparative Analysis of Fowler-Stephens versus Shehata Surgical Techniques in the Management of High Intra-Abdominal Testes in Pediatric Patients, A pilot study
Brief summary describing the background and objectives of the trial Cryptorchidism, also known as undescended testis, is a prevalent condition in paediatric urology that manifests with varying incidences across different infant populations. It ranges from 9.2 to 30% in preterm infants and 3.4 to 5.8% in full-term infants. The primary aetiology lies in the failure of testicular descent from the abdominal region into the scrotal sac, categorizing cryptorchidism into inguinal and intra-abdominal testes (IATs) based on testicular location. Notably, approximately 20% of undescended testes are impalpable, with the majority being IATs. While imaging modalities like ultrasound and magnetic resonance aid diagnosis, laparoscopic exploration remains pivotal for diagnosing and treating IAT. The challenge persists in laparoscopically managing high IAT due to the limited length of testicular blood vessels within the abdominal cavity. The standard of care for IAT was pioneered by Fowler and Stephens with single-stage testicular descent fixation in 1959, initially involving spermatic vascular transection. Subsequent modifications led to ligating spermatic vessels, followed by staged surgery where the testes remain in situ within the abdomen. Recently in 2008, Shehata introduced laparoscopic testicular traction and fixation for high IAT treatment. This technique removes the need for spermatic cord blood vessel transection, instead utilizing intestinal gravity to gently and continuously provide traction on the testicular blood vessels, The technique entails fixation of the testis to a point one inch above and medial to the contralateral anterior superior iliac spine for 12 weeks.Subdartos orchiopexy is then done at the second stage. Both stages are laparoscopically assisted. However, it is still debated whether the Shehata surgery offers superior benefits compared to F-S surgery. We aim to compare the success and complication rates and duration of surgery and hospital stay of both methods.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2024
Actual trial start date
Anticipated date of last follow up 01/08/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional treatment of undescended testies Two steps surgery Fowler-Stephens technique for the management of intra-abdominal testes: During the first step, the spermatic vessels are clipped 3-4 cm proximally to the testis. The second step of the Fowler-Stephens procedure is done 3-6 months later. 12 Active-Treatment of Control Group
Experimental Group Shehata technique two-stage surgery -fixing the testis to a point 2.5 cm above and medial to the contralateral anterior superior iliac spine during stage I surgery -Removal of the sutures from the testis and the adhesions between the testis and descension into the scrotum in stage 2 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. 16-year-old male patients or less diagnosed with high intra-abdominal testes (IAT), whom a legal guardian agreed to participate in the study and signed an informed consent. 2. Patients scheduled for surgical intervention with either Fowler-Stephens (F-S) or Shehata procedure. 1. Patients with a history of previous surgical intervention for cryptorchidism. 2. Patients with contraindications to laparoscopic surgery or general anaesthesia. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 16 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 24/07/2024 Medical Ethics Committee School of Medicine Assiut University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Assiut University, Assiut. Assiut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immediate Success Rate: The primary outcome measure will be the success rate of the surgical procedure, defined as the percentage of patients in whom successful testicular descent into the scrotum is achieved postoperatively. Immediate
Secondary Outcome 1. Short-term success rates: Clinically by having non-atrophic, intrascrotal testis at postoperative follow-up and radiologically by having intact vascularity by US at 3 months, postoperatively. 2. Complication Rate: The incidence of intraoperative and postoperative complications, including but not limited to bleeding, infection, testicular atrophy, and reoperation rates 3. Duration of Surgery: The duration of surgical procedures. 4. Length of Hospital Stay: The length of hospital stay post-surgery Immediate: point 4, Days: point 3, Days to 3 months: point 2, 3 month: point 1
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Hospital Bessary way, Assiut, 71515, Egypt Assiut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Faculty of Medicine, Assiut University, Assiut. Assiut 71511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assiut university Faculty of Medicine, Assiut University, Assiut. Assiut Egypt Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adham Sleem adhamosama919@gmail.com +201143369811 85 el helaly street assiut Egypt
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Urology resident Assiut univeristy
Role Name Email Phone Street address
Public Enquiries Adham Sleem Adhamosama919@gmail.com +201143369811 85 el helaly street Assiut Egypt
City Postal code Country Position/Affiliation
Assiut Egypt Urology resident
Role Name Email Phone Street address
Scientific Enquiries Adham Sleem adhamosama919@gmail.com +201143369811 85 el helaly street Assiut Egypt
City Postal code Country Position/Affiliation
Assiut Egypt Urology resident Assiut university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data Availability The data that support the findings of this study will be available from the corresponding author, upon reasonable request. The following types of data will be shared: De-identified individual participant data. Study protocol. Statistical analysis plan. Access Criteria Researchers who provide a methodologically sound proposal will be granted access to the data. Proposals should be directed to [contact email]. To gain access, researchers will need to sign a data access agreement. Data Sharing Mechanism Data will be shared through the author upon reasonable request. Restrictions The data will be de-identified to protect participant privacy. Data use will be limited to non-commercial research purposes only. Contact Information For further inquiries, please contact the corresponding author. Informed Consent Form Timing The data will be available immediately following publication and will be accessible for 5 years. The data will be de-identified to protect participant privacy. Data use will be limited to non-commercial research purposes only.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 27/07/2024 As suggested by reviewer Cryptorchidism, also known as undescended testis, is a prevalent condition in paediatric urology that manifests with varying incidences across different infant populations. It ranges from 9.2 to 30% in preterm infants and 3.4 to 5.8% in full-term infants. The primary aetiology lies in the failure of testicular descent from the abdominal region into the scrotal sac, categorizing cryptorchidism into inguinal and intra-abdominal testes (IATs) based on testicular location. Notably, approximately 20% of undescended testes are impalpable, with the majority being IATs. While imaging modalities like ultrasound and magnetic resonance aid diagnosis, laparoscopic exploration remains pivotal for diagnosing and treating IAT. The challenge persists in laparoscopically managing high IAT due to the limited length of testicular blood vessels within the abdominal cavity. The standard of care for IAT was pioneered by Fowler and Stephens with single-stage testicular descent fixation in 1959, initially involving spermatic vascular transection. Subsequent modifications led to ligating spermatic vessels, followed by staged surgery where the testes remain in situ within the abdomen. Recently in 2008, Shehata introduced laparoscopic testicular traction and fixation for high IAT treatment. This technique removes the need for spermatic cord blood vessel transection, instead utilizing intestinal gravity to gently and continuously provide traction on the testicular blood vessels, The technique entails fixation of the testis to a point one inch above and medial to the contralateral anterior superior iliac spine for 12 weeks. Subdartos orchiopexy is then done at the second stage. Both stages are laparoscopically assisted. However, it is still debated whether the Shehata surgery offers superior benefits compared to F-S surgery. Cryptorchidism, also known as undescended testis, is a prevalent condition in paediatric urology that manifests with varying incidences across different infant populations. It ranges from 9.2 to 30% in preterm infants and 3.4 to 5.8% in full-term infants. The primary aetiology lies in the failure of testicular descent from the abdominal region into the scrotal sac, categorizing cryptorchidism into inguinal and intra-abdominal testes (IATs) based on testicular location. Notably, approximately 20% of undescended testes are impalpable, with the majority being IATs. While imaging modalities like ultrasound and magnetic resonance aid diagnosis, laparoscopic exploration remains pivotal for diagnosing and treating IAT. The challenge persists in laparoscopically managing high IAT due to the limited length of testicular blood vessels within the abdominal cavity. The standard of care for IAT was pioneered by Fowler and Stephens with single-stage testicular descent fixation in 1959, initially involving spermatic vascular transection. Subsequent modifications led to ligating spermatic vessels, followed by staged surgery where the testes remain in situ within the abdomen. Recently in 2008, Shehata introduced laparoscopic testicular traction and fixation for high IAT treatment. This technique removes the need for spermatic cord blood vessel transection, instead utilizing intestinal gravity to gently and continuously provide traction on the testicular blood vessels, The technique entails fixation of the testis to a point one inch above and medial to the contralateral anterior superior iliac spine for 12 weeks.Subdartos orchiopexy is then done at the second stage. Both stages are laparoscopically assisted. However, it is still debated whether the Shehata surgery offers superior benefits compared to F-S surgery. We aim to compare the success and complication rates and duration of surgery and hospital stay of both methods.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 27/07/2024 As suggested by reviewer Secondary Outcome, 1. Short term success rates: Clinically by having non-atrophic, intrascrotal testis at postoperative follow-up and radiologically by having intact vascularity by US at 3 months, postoperatively. 2. Complication Rate: The incidence of intraoperative and postoperative complications, including but not limited to bleeding, infection, testicular atrophy, and reoperation rates 3. Duration of Surgery: The duration of surgical procedures, from incision to closure 4. Length of Hospital Stay: The length of hospital stay post-surgery , Form days to 3 months Secondary Outcome, 1. Short-term success rates: Clinically by having non-atrophic, intrascrotal testis at postoperative follow-up and radiologically by having intact vascularity by US at 3 months, postoperatively. 2. Complication Rate: The incidence of intraoperative and postoperative complications, including but not limited to bleeding, infection, testicular atrophy, and reoperation rates 3. Duration of Surgery: The duration of surgical procedures. 4. Length of Hospital Stay: The length of hospital stay post-surgery , Immediate: point 4, Days: point 3, Days to 3 months: point 2, 3 month: point 1
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/12/2024 Approval granted FALSE, Medical Ethics Committee School of Medicine Assiut University, Faculty of Medicine, Assiut University, Assiut., Assiut, 71515, Egypt, 24 Jul 2024, , 0882411906, irbasyut@aun.edu.eg, TRUE, Medical Ethics Committee School of Medicine Assiut University, Faculty of Medicine, Assiut University, Assiut., Assiut, 71515, Egypt, 24 Jul 2024, 10 Dec 2024, 0882411906, irb_asyut@aun.edu.eg, 30698_29780_4737.pdf