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A Novel Technique of Circumcision Incision Orchidopexy

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ClinicalTrials.gov Identifier: NCT02249637
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Michael E. Chua, St. Luke's Medical Center, Philippines

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.

Condition or disease Intervention/treatment
Cryptorchidism Undescended Testis Procedure: Novel technique Circumcision Incision 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.


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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Novel Technique of Circumcision Incision Orchidopexy for Palpable Low Inguinal Cryptorchidism: A Preliminary Report
Study Start Date : September 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
Inguinal Orchidopexy
Patients with diagnosed palpable low inguinal cryptorchidism underwent inguinal approach as originally described by Schuller and Bevan.
Novel Technique (Circumcision incision)
Patients with diagnosed palpable low inguinal cryptorchidism underwent novel technique- circumcision incision orchidopexy.
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.
Other Name: Chua's Procedure




Primary Outcome Measures :
  1. Complication rate occurence related to the procedure [ Time Frame: 3 months- 5 years ]
    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


Secondary Outcome Measures :
  1. Visual analogue scale (VAS) pain score post-operation [ Time Frame: post-operative 24-48 hour ]
    Average pain score post operation as described by the patient using visual analogue scale

  2. Parent's satisfaction score for the procedure post-operation [ Time Frame: 1 week post operative follow up ]
    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

  3. Operative time consumed by the procedure [ Time Frame: Operative time ]
    Time from incision to incision closure end



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Ages Eligible for Study:   3 Months to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249637


Locations
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Philippines
Institute of Urology
Quezon City, NCR, Philippines
Sponsors and Collaborators
St. Luke's Medical Center, Philippines
The Hospital for Sick Children

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Responsible Party: Michael E. Chua, Urology Staff, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier: NCT02249637     History of Changes
Other Study ID Numbers: SLMC_2014(SLIU1)
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Cryptorchidism
Testicular Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases