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临床试验/CTRI/2025/03/082862
CTRI/2025/03/082862尚未招募不适用

Assessment of testicular morphology after orchidopexy for undescended testis using ultrasound

未提供1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
To assess success rates of laparoscopic staged Fowler Stephen’s and open orchiopexy by comparing pre and post-operative testicular volume by ultrasonography I.E TESTICULAR ATROPHY RATES

研究概览

简要总结

Allchildren between 0-8 years who had undergone staged Fowler Stephen’s orchiopexyor open orchidopexy  and had come forfollow up to the Department of Paediatric surgery, KMC Manipal after 6 monthsof procedure between February 1 2025 and January 31st 2026 will berecruited in the study and follow up ultrasound of the scrotum will be obtainedif the same was not already done following which pre and postoperativetesticular volumes will be compared. A prestructured proforma designed byauthors will be used.

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

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

 Data will be collected on patient demographics, preoptesticular volume, unilateral or bilateral, palpable or nonpalpableintraoperative variables, Time period between surgery, associated anomaly andoutcomes including complications.

A full list of required data fields captured on theproforma

Follow up:

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

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

of surgery is day zero).

Atrophic testis criteria

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

Outcome measures:

Testicualr atrophy rate

14. Review ofliterature (within 1000 words):

Around1–9% 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 AmericanUrological Association (AUA) guidelines state that a skilled provider can feelmore than 70% of cryptorchid testes during a physical exam, making imagingunnecessary for these cases. For the remaining 30% of cases, the difficulty isin confirming the testicle’s existence or nonexistence and figuring out thelocation of a functioning non-palpable testicleee months, but around 1% of boysstill have undescended testicles by their first birthday. Regarding undescendedtesticles, medical imaging plays a crucial role in pinpointing the testes’location, which helps in planning surgeries more effectively, reducing the needfor exploratory procedures, and cutting down on the time spent underanesthesia. Techniques like MRI and ultrasound are especially effective infinding and diagnosing undescended testicles, as they are non-invasive and donot expose the patient to harmful radiation. The success rate of MRI andultrasound in diagnosing testicular issues is on par with other diagnostictools. Surgicalintervention is recommended between 6-18 months. Specialists advise surgery tobe 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 fororchiopexy. 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), theflexibility of the blood vessels around the testicle (if they’re too tight, a2-stage method might be necessary), and the age of the patient (older patientsmight benefit from a 2-stage method). Although the success rates for bothmethods are generally the same, a 1-stage method is often chosen if it’stechnically possible.

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

Thestudy by Alam et al. aimed to examine the effectiveness of single-stagelaparoscopic orchiopexy (SSLO) and the staged Fowler-Stephens (SFS) methods intreating undescended testes inside the abdomen. Authors reviewed the medicalrecords of 73 patients (85 testes) who had surgery for undescended testes fromNovember 2006 to November 2014. They abstracted the patients’ basic informationon the position and size of the testes before and after the surgery. Theresearch showed that out of the 85 surgeries, 35 were done with SFS and 50 withSSLO. The patients were similar in age at the time of surgery (median age of 12months) and the mean follow-up is 17.3 months. After the surgery, there were noreports of testes being in the wrong position in the SFS group, but 10 out ofthe 50 SSLO patients (20.0%) had testes in the wrong position. The chance ofhaving testes in the wrong position with SSLO compared to SFS was 0.05 (with aconfidence interval of 0.01 to 0.44). However, there was no apparent differencein testicular shrinkage. Wael et al. compared the outcomes of one-stage and twostage laparoscopic Fowler-Stephens orchiopexy (LFSO). Intra-abdominal testes(IATs) with short spermatic vessels were included in both the groups. The studywas conducted between January 2012 and December 2014, including IAT type 3A, 3Band 4A per the updated Ain Shams classification. Follow-up was conducted at 6,12 and 36 months postoperatively using Doppler ultrasound in the first twovisits.

Asimilar subgroup of the historical cohort from 2002 to 2010 had a two-stageLFSO, with the second stage performed 12-16 weeks later. In bilateral cases, athree-interval surgery based on two-stage LFSO was performed, with a follow-upat 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%) werenormal. In those viable, only half of them had a low scrotal position. Therewas no difference in outcomes observed at 12- or 36-month follow-up. Dopplerultrasound confirmed adequate intratesticular blood flow at 6 and 12 monthspostoperatively. The study determined higher testicular atrophy among theone-stage operated patients

15. References:

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

2.      Leslie SW, Sajjad H, Villanueva CA.Cryptorchidism. In: StatPearls [Internet]. Treasure Island (FL): StatPearlsPublishing; 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 inchildhood and adolescence and testicular cancer in adults: an updatedsystematic review and meta-analysis of observational studies. Eur J Pediatr.2023 Jun;182(6):2499–507.

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

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 8.00 Year(s)(—)
性别
Male

入选标准

  • 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 31st 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.

排除标准

  • not consenting for surgery.

结局指标

主要结局

To assess success rates of laparoscopic staged Fowler Stephen’s and open orchiopexy by comparing pre and post-operative testicular volume by ultrasonography I.E TESTICULAR ATROPHY RATES

时间窗: 6 months to 1 year post surgery

次要结局

  • NA(NA)

研究者

发起方
未提供

研究点 (1)

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