Expertise-Based Randomized Controlled Trial of Scrotal Versus Inguinal Orchidopexy on Post-operative Pain

NCT02158780 | Completed DMC

• 1 other identifier: EXPRESSO
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Undescended Testis is the most common congenital abnormality of the genitalia in boys and it is commonly managed by surgical intervention. Evidence in the medical literature to support the superiority of either scrotal or inguinal (standard) orchidopexy is lacking. To determine which technique is superior, this study focuses on the degree of post-operative pain after surgery. Therefore, the objective of this randomized control trial is to determine if scrotal orchidopexy reduces postoperative pain in children diagnosed with undescended testis when compared to standard inguinal orchidopexy.

Conditions

Low-lying Unilateral Palpable Undescended Testis

Outcome Measures

Primary Outcomes (2)

• Analgesic use post-operatively (during hospital stay)

  Defined as the number of doses of morphine (standardized dose of 0.2 mg/kg) or Tylenol (15mg/kg) or Ibuprofen (10mg/kg) administered by PACU and SDSU nurses following surgery.

  Measured dosage post-surgery (on average 45 minutes later)

• Analgesic use post-discharge

  Defined as number of standardized doses of Tylenol (15 mg/kg) and Ibuprofen (10 mg/kg) administered by parent/guardian at home post-discharge.

  Measure at 6 hour intervals post discharge for 48 hours

Secondary Outcomes (9)

• Pain Scales post-operative (during hospital stay)

  Measure at patient admission and discharge at 30 minute intervals.

• Pain Scales post-operative (during hospital stay)

  Measure at patient admission and discharge at 30 minute intervals.

• Pain scales post-discharge

  Measure at 6 hour intervals post discharge for 48 hours

• Analgesic use

  Measured dosage at the beginning of surgery and post-surgery (on average 45minutes later)

• Duration of surgery (min)

  Record duration of operative time (takes on average 30-45 minutes)

Study Arms (2)

Scrotal Orchidopexy

EXPERIMENTAL

Single incision

Procedure: Scrotal Orchidopexy

Inguinal Orchidopexy

OTHER

Double Incision (Standard)

Procedure: Inguinal Orchidopexy

Interventions

Scrotal Orchidopexy PROCEDURE

Single incision

Scrotal Orchidopexy

Inguinal Orchidopexy PROCEDURE

Double Incision (Standard)

Inguinal Orchidopexy

Eligibility Criteria

• Age: 10 Months - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis with palpable undescended testis (or testes);
• Child is between 10 mos - 7 years of age;
• Child requires either scrotal or inguinal orchidopexy

You may not qualify if:

• Laparoscopic surgery for intra-abdominal testis or peeping testis (carnalicular);
• Child underwent previous orchidopexy surgery

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (1)

McMaster Children Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Study Officials

• Luis Braga, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: June 9, 2014
• Study Start: January 1, 2015
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: February 25, 2021

Record last verified: 2019-08

Locations

CA (1)