Clinical trial NCT02158780: Expertise-Based Randomized Controlled Trial of Scrotal Versus Inguinal Orchidopexy on Post-operative Pain
Official title: Expertise-Based Randomized Controlled Trial of Scrotal Versus Inguinal (Standard) Orchidopexy on Postoperative Pain: EXPRESSO Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low-lying Unilateral Palpable Undescended Testis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
First posted: 2014-06-09
Enrollment: 162
Sex: MALE
Minimum age (years): 10
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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. At the first pre-operative clinic visit participating paediatric urologist will diagnose patients with low-lying palpable UDT. Patients who meet eligibility criteria will be invited to participate in this trial. A computer generated randomization list will be created using random blocks of multiple sizes (4, 6 and 8), by the McMaster Paediatric Surgery Research Collaborative's web-based randomization system. Patients will be allocated to intervention (scrotal orchidopexy) or control (standard inguinal orchidopexy) groups by logging in to the secure central randomization website. Patients will be stratified and randomized by centre into a 1:1 parallel allocation ratio.Primary Outcome: Post-operative pain during recovery phase Sample size calculated using single primary outcome of analgesic use. However, pain will also be measured in alternative ways using pain scales as a secondary outcome. Analgesic use post-operatively (during hospital stay): Defined as the number of doses and total consumption of morphine (standardized dose of 0.2 mg/kg/dose orally or 0.02 to 0.1 mg/kg/dose IV) or oral acetaminophen (15mg/kg/dose) or Ibuprofen (10mg/kg/dose) administered by PACU and SDSU nurses following surgery. Analgesic use post-discharge: Defined as number of standardized doses and total consumption of acetaminophen (15 mg/kg/dose) and Ibuprofen (10 mg/kg/dose) administered by parent/guardian at home post-discharge.Secondary Outcomes: Duration of surgery, Pain Scores, Success rate, Complications. Duration of surgery (min): Defined as time beginning when anesthesia is ready until patient is moved to PACU. Recorded on patient discharge sheet by study nurse. Time to discharge: Defined as duration of time from entering PACU to readiness to discharge from PACU or same day-surgery unit (if applicable). Recording by study nurse on discharge sheet. Pain Scales post-operative:Mean of highest pain score in each patient: Self-reported pain scales are gold-standard for reporting pain; however, since this study sample comprises of pre-verbal children, an observer pain tool will be used. Specifically, pain scores will be measured through a reliable and validated observer-rated Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Scale30 by two trained, blinded, and independent study personnel. Both study personnel will measure pain at admission and discharge during the recovery phase. Recovery phase is defined as post-operative period in the post-anesthesia care unit (PACU) and same day surgery unit (SDSU). Patients usually recover for an average of two hours before being discharged. Highest pain score will be determined by blinded analysts. At monthly intervals, inter-rater reliability between study personnel will be assessed and re-trained to ensure high consistency in score ratings.

Mean overall pain sore: Average pain score (standard deviation) throughout recovery phase. Pain scales post-discharge: Information measured at home by parent/guardian. Collected by study personnel at 24 hour follow-up telephone call. Mean of the highest pain score in each patient: Assessed through validated and reliable Parents Postoperative Pain Measure (PPPM)and Toddler-Preschooler Postoperative Pain Scale (TPPPS) by trained and parent/guardian 24 hrs post-discharge. Complication rate: Defined as number of complications per group. Complications include surgical site infection, scrotal hematoma, bleeding, scrotal swelling, hernia formation, testicular atrophy, and wound dehiscence. Assessed 6-8 weeks post-surgery by a trained clinician who was not involved in administering surgery for this study. Success rate of procedure: Defined as number of testis successfully lowered into the lower scrotum at a 6-8 week follow-up visit evaluated by a trained clinician.

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

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

Primary outcomes:
measure: Analgesic use post-operatively (during hospital stay)
timeFrame: Measured dosage post-surgery (on average 45 minutes later)
measure: Analgesic use post-discharge
timeFrame: Measure at 6 hour intervals post discharge for 48 hours
Secondary outcomes:
measure: Pain Scales post-operative (during hospital stay)
timeFrame: Measure at patient admission and discharge at 30 minute intervals.
measure: Pain Scales post-operative (during hospital stay)
timeFrame: Measure at patient admission and discharge at 30 minute intervals.
measure: Pain scales post-discharge
timeFrame: Measure at 6 hour intervals post discharge for 48 hours
measure: Analgesic use
timeFrame: Measured dosage at the beginning of surgery and post-surgery (on average 45minutes later)
measure: Duration of surgery (min)
timeFrame: Record duration of operative time (takes on average 30-45 minutes)
measure: Time to discharge
timeFrame: Duration of time from being admitted for surgery until time discharged (which is on average 4 hours)
measure: Short term complications
timeFrame: Measured at 48 hour follow-up clinic visit
measure: Long-term complications
timeFrame: Measured at 3 and 6 month follow-up clinic visit
measure: Success rate
timeFrame: Measured at 3 month followup clinic visit
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Luis Braga, MD
role: PRINCIPAL_INVESTIGATOR
References: