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CompletedNCT02249637Updated Apr 7, 2015

A Novel Technique of Circumcision Incision Orchidopexy

An observational study in Cryptorchidism and Undescended Testis, sponsored by St. Luke's Medical Center, Philippines. Completed at 1 site in Philippines. Open to male participants aged 3 Months to 10 Years. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by St. Luke's Medical Center, Philippines · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
14
Ages
3 Months to 10 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Cryptorchidism
  • Undescended Testis

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03

In context

Cryptorchidism

40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.

This study's enrollment of 14 is below the median of 100 across 14 observational studies indexed under Cryptorchidism.

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Lead sponsor

St. Luke's Medical Center, Philippines is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 10 Years
Sexes eligible
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

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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

Exclusion Criteria:

  • Excluded were non-palpable testis, with prior orchidopexy, circumcised, with other concomitant genital anomalies.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureNovel 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.

    Also known as: Chua's Procedure

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months- 5 years

Secondary outcomes

  1. Visual analogue scale (VAS) pain score post-operation

    Average pain score post operation as described by the patient using visual analogue scale

    Time frame: post-operative 24-48 hour

  2. 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

    Time frame: 1 week post operative follow up

  3. Operative time consumed by the procedure

    Time from incision to incision closure end

    Time frame: Operative time

07

Study locations

1 site
  • Institute of Urology
    Quezon City, NCR, Philippines
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02249637
Lead sponsor
St. Luke's Medical Center, Philippines
Responsible party
Michael E. Chua (Urology Staff, St. Luke's Medical Center, Philippines) — Principal investigator
First posted
Sep 25, 2014
Start date
Sep 2013
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Apr 7, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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