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A Novel Technique of Circumcision Incision Orchidopexy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 18, 2014
First Posted Date September 25, 2014
Last Update Posted Date April 7, 2015
Study Start Date September 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 22, 2014)
  • 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
  • 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
  • Operative time consumed by the procedure [ Time Frame: Operative time ]
    Time from incision to incision closure end
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Novel Technique of Circumcision Incision Orchidopexy
Official Title A Novel Technique of Circumcision Incision Orchidopexy for Palpable Low Inguinal Cryptorchidism: A Preliminary Report
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • 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.
Other Name: Chua's Procedure
Study Groups/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.
    Intervention: Procedure: Novel technique Circumcision Incision Orchidopexy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2015)
14
Original Estimated Enrollment
 (submitted: September 22, 2014)
10
Actual Study Completion Date December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 3 Months to 10 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT02249637
Other Study ID Numbers SLMC_2014(SLIU1)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael E. Chua, St. Luke's Medical Center, Philippines
Study Sponsor St. Luke's Medical Center, Philippines
Collaborators The Hospital for Sick Children
Investigators Not Provided
PRS Account St. Luke's Medical Center, Philippines
Verification Date April 2015