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Completed

NCT Number: NCT02249637

A Novel Technique of Circumcision Incision Orchidopexy

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.

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Key information

Conditions

Cryptorchidism Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Genital Diseases Genital Diseases, Male Gonadal Disorders Male Urogenital Diseases Testicular Diseases Undescended Testis Urogenital Abnormalities Urogenital Diseases

Age range

3 month–10 year

Sex eligibility

Male

Study type

Observational

Primary location

Institute of Urology

Quezon City, NCR, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novel technique Circumcision Incision Orchidopexy

Procedure

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 names: Chua's Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Luke's Medical Center, Philippines

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 25, 2014
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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