1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [VIJAY.KUMAR@MANIPAL.EDU].
   


6. For how long will this data be available start date provided 01-04-2025 and end date provided 31-03-2029?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

All children between 0-8 years who had undergone staged Fowler Stephen’s orchiopexy or open orchidopexy  and had come for follow up to the Department of Paediatric surgery, KMC Manipal after 6 months of procedure between February 1 2025 and January 31^st 2026 will be recruited in the study and follow up ultrasound of the scrotum will be obtained if the same was not already done following which pre and postoperative testicular volumes will be compared. A prestructured proforma designed by authors will be used.

Ultrasound in post op patients of repair of undescended testes at 6 months- 1year of age is a routine standard of care to access the status of testes after orchidopexy.

Testicular volume on ultrasound will be calculated by Length x breadth height x0.71. Testicular volume will be compared with the contralateral normal testis if unilateral and to the standard reference values as per study by Srinivas et al(reference)

Data will be collected on patient demographics, preop testicular volume, unilateral or bilateral, palpable or nonpalpable intraoperative variables, Time period between surgery, associated anomaly and outcomes including complications.

A full list of required data fields captured on the proforma

Follow up:

No additional follow-up is required for this study. Routing follow up between 6-12 months after surgery will be noted from the case file.Follow-up data will be collected from routine health records.

The key performance outcome measures (see above) will be assessed at or after postoperative day 180 (the day

of surgery is day zero).

Atrophic testis criteria

There is no fixed or gold standard protocol for declaring significant volume loss, thus eventually declaring atrophy of the testis. However, there are few studies which declares >20% reduction of testicular volume as significant to declare as atrophic testis

Outcome measures:

Testicualr atrophy rate

14. Review of literature (within 1000 words):

Around 1–9% of male babies have one or both testicles not descending into the scrotum. About half of these cases naturally descend within the first thr. The American Urological Association (AUA) guidelines state that a skilled provider can feel more than 70% of cryptorchid testes during a physical exam, making imaging unnecessary for these cases. For the remaining 30% of cases, the difficulty is in confirming the testicle’s existence or nonexistence and figuring out the location of a functioning non-palpable testicleee months, but around 1% of boys still have undescended testicles by their first birthday. Regarding undescended testicles, medical imaging plays a crucial role in pinpointing the testes’ location, which helps in planning surgeries more effectively, reducing the need for exploratory procedures, and cutting down on the time spent under anesthesia. Techniques like MRI and ultrasound are especially effective in finding and diagnosing undescended testicles, as they are non-invasive and do not expose the patient to harmful radiation. The success rate of MRI and ultrasound in diagnosing testicular issues is on par with other diagnostic tools. Surgical intervention is recommended between 6-18 months. Specialists advise surgery to be done in 6 months around because it optimizes testicular growth and fertility. Various factors influence the decision to use a 1-stage or 2-stage method for orchiopexy. These include the distance from the testicle to the internal ring (if it’s more than 2.5 cm, a 2-stage method is usually recommended), the flexibility of the blood vessels around the testicle (if they’re too tight, a 2-stage method might be necessary), and the age of the patient (older patients might benefit from a 2-stage method). Although the success rates for both methods are generally the same, a 1-stage method is often chosen if it’s technically possible.

The Shehata technique is favoured over a single-stage approach when performing a single-stage Fowler-Stephens surgery is impossible. This technique helps maintain the testicle’s blood supply, reduces shrinkage, and generally leads to higher success rates. Laparoscopic 1-stage Fowler-Stephens surgery, while it doesn’t preserve the primary testicular blood vessels, avoids the need for a second surgery and anaesthesia in infants.

The study by Alam et al. aimed to examine the effectiveness of single-stage laparoscopic orchiopexy (SSLO) and the staged Fowler-Stephens (SFS) methods in treating undescended testes inside the abdomen. Authors reviewed the medical records of 73 patients (85 testes) who had surgery for undescended testes from November 2006 to November 2014. They abstracted the patients’ basic information on the position and size of the testes before and after the surgery. The research showed that out of the 85 surgeries, 35 were done with SFS and 50 with SSLO. The patients were similar in age at the time of surgery (median age of 12 months) and the mean follow-up is 17.3 months. After the surgery, there were no reports of testes being in the wrong position in the SFS group, but 10 out of the 50 SSLO patients (20.0%) had testes in the wrong position. The chance of having testes in the wrong position with SSLO compared to SFS was 0.05 (with a confidence interval of 0.01 to 0.44). However, there was no apparent difference in testicular shrinkage. Wael et al. compared the outcomes of one-stage and two stage laparoscopic Fowler-Stephens orchiopexy (LFSO). Intra-abdominal testes (IATs) with short spermatic vessels were included in both the groups. The study was conducted between January 2012 and December 2014, including IAT type 3A, 3B and 4A per the updated Ain Shams classification. Follow-up was conducted at 6, 12 and 36 months postoperatively using Doppler ultrasound in the first two visits.

A similar subgroup of the historical cohort from 2002 to 2010 had a two-stage LFSO, with the second stage performed 12-16 weeks later. In bilateral cases, a three-interval surgery based on two-stage LFSO was performed, with a follow-up at 6 months postoperatively. Among the 16 IATs (10 unilateral and 3 bilateral) operated, the median age of the patients was 1.41 years. At 6-month follow-up, 4 had testicular atrophy (25%), whereas the remaining 12 testes (75%) were normal. In those viable, only half of them had a low scrotal position. There was no difference in outcomes observed at 12- or 36-month follow-up. Doppler ultrasound confirmed adequate intratesticular blood flow at 6 and 12 months postoperatively. The study determined higher testicular atrophy among the one-stage operated patients

15. References:

1.      Docimo G. Steven. The Kelalis-King-Belman Textbook of Clinical Pediatric Urology. Sixth edition.

2.      Leslie SW, Sajjad H, Villanueva CA. Cryptorchidism. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 [cited 2024 Jun 7]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK470270/

3.      Florou M, Tsilidis KK, Siomou E, Koletsa T, Syrnioti A, Spyridakis I, et al. Orchidopexy for congenital cryptorchidism in childhood and adolescence and testicular cancer in adults: an updated systematic review and meta-analysis of observational studies. Eur J Pediatr. 2023 Jun;182(6):2499–507.

4.      Canadian Urological Association-Pediatric Urologists of Canada (CUA-PUC) guideline for the diagnosis, management, and followup of cryptorchidism - PMC [Internet]. [cited 2024 Jun 7]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5519382/