Clinical trial NCT02249637: A Novel Technique of Circumcision Incision Orchidopexy
Official title: A Novel Technique of Circumcision Incision Orchidopexy for Palpable Low Inguinal Cryptorchidism: A Preliminary Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryptorchidism
Undescended Testis
Lead sponsor: St. Luke's Medical Center, Philippines
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2014-09-25
Enrollment: 14
Sex: MALE
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with palpable cryptorchidism with pre-operative inguino-scrotal ultrasound to confirm the location of the testis on the low inguinal canal and its viability. Recruited from September 2013- September 2014

Brief summary: Given that both circumcision and orchidopexy are commonly done in a single setting, the investigators adopted the technique of orchidopexy via circumcision incision, particularly for palpable low inguinal cryptorchidism. In this paper, the investigators aim to present a novel technique and discuss our preliminary outcome of such procedure compared to the traditional inguinal-scrotal double incision technique. Specifically, the investigators aimed to determine the differences in operative time, testicular size changes, peri-operative complications, pain score and parent's satisfaction of both novel technique and conventional orchidopexy.

Detailed description: Cryptorchidism is the most common disorder of the male endocrine gland in children.. 1 According to the latest guideline by European Association of Urology in the Pediatric Urology for the treatment of cryptorchidism, both inguinal and scrotal approaches orchidopexy are accepted standard treatment options. 2 In the local setting, circumcision is another common surgical procedure among the children, particularly under the same instance of anesthesia for other procedure. Not only due to religious and sociocultural reasons, male circumcision has been recently considered having a protective effect against acquisition of various sexually transmitted infections (STIs). 3 This benefit is one of many that have led to many affirmative evidence-based policy statements by medical bodies in support of the procedure.

Given that both procedures are commonly done in a single setting, we adopted the technique of orchidopexy via circumcision incision, particularly for palpable low inguinal cryptorchidism. In this paper, we aim to present a novel technique and discuss our preliminary outcome of such procedure compared to the traditional inguinal-scrotal double incision technique. Specifically, we aimed to determine the differences in operative time, testicular size changes, peri-operative complications, pain score and parent's satisfaction of both novel technique and conventional orchidopexy.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with palpable cryptorchidism with pre-operative inguino-scrotal ultrasound to confirm the location of the testis on the low inguinal canal and its viability.

Exclusion Criteria:

* Excluded were non-palpable testis, with prior orchidopexy, circumcised, with other concomitant genital anomalies.

Primary outcomes:
measure: Complication rate occurence related to the procedure
timeFrame: 3 months- 5 years
Secondary outcomes:
measure: Visual analogue scale (VAS) pain score post-operation
timeFrame: post-operative 24-48 hour
measure: Parent's satisfaction score for the procedure post-operation
timeFrame: 1 week post operative follow up
measure: Operative time consumed by the procedure
timeFrame: Operative time
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: Institute of Urology
state: NCR
Study officials:
References: