A Novel Technique of Circumcision Incision Orchidopexy

NCT02249637 | Completed DMC

• 1 other identifier: SLMC_2014(SLIU1)
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryptorchidism; Undescended Testis

Outcome Measures

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

  3 months- 5 years

Secondary Outcomes (3)

• Visual analogue scale (VAS) pain score post-operation

  post-operative 24-48 hour

• Parent's satisfaction score for the procedure post-operation

  1 week post operative follow up

• Operative time consumed by the procedure

  Operative time

Study Arms (2)

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

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.

Also known as: Chua's Procedure

Novel Technique (Circumcision incision)

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Luke's Medical Center, Philippines: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

Institute of Urology

Quezon City, NCR, Philippines

Location

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Staff

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

PH (1)