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