A Novel Technique of Circumcision Incision Orchidopexy

Cryptorchidism Clinical Trial

Official title:

A Novel Technique of Circumcision Incision Orchidopexy for Palpable Low Inguinal Cryptorchidism: A Preliminary Report

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249637
• Other study ID #: SLMC_2014(SLIU1)
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: April 5, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: St. Luke's Medical Center, Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of HealthPhilippines: Ethics CommitteePhilippines: Philippine Council for Health Research and Development
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Months to 10 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cryptorchidism
• Undescended Testis

Intervention

Procedure:
• Novel technique Circumcision Incision Orchidopexy
The novel technique starts with retraction of the prepucial skin off the glans penis and double incision circumcision done with mucosal sparing, then degloving of the penis on the side of the undescended testis. Dissection via Dartos' layer into the inguinal area until the palpable testicle was identified and extracted with mobilization of the spermatic cord. Hernia sac was then separated and suture ligated as high as the area of internal ring opening. Spematic cord lengthening was done until adequate length achieved for fixation into the inferior aspect of the scrotum. Then development of the Dartos' pouch via the circumcision site was done. A double or single suture testicular fixation using Vicryl 3-0 simple interrupted sutures on the everted Dartos' pouch inner surface was done. Subsequent placement of the testicle into the Dartos' pouch was done as the inner surface was inverted. The last step was the completion of the circumcision closure using Chromic 4-0 interrupted sutures.

Locations

Country	Name	City	State
Philippines	Institute of Urology	Quezon City	NCR

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's Medical Center, Philippines	The Hospital for Sick Children

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate occurence related to the procedure	Perioperative complications such as incidents of persistence of procesus vaginalis, testicular atrophy, hematoma, surgical site wound infection as well as the post-operative outcome such as testicular size changes	3 months- 5 years	Yes
Secondary	Visual analogue scale (VAS) pain score post-operation	Average pain score post operation as described by the patient using visual analogue scale	post-operative 24-48 hour	No
Secondary	Parent's satisfaction score for the procedure post-operation	Parent's satisfaction score measured as 1-5 scale, with 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 being satisfied, 5 being very satisfied	1 week post operative follow up	No
Secondary	Operative time consumed by the procedure	Time from incision to incision closure end	Operative time	No