Expertise-Based Randomized Controlled Trial of Scrotal Versus Inguinal Orchidopexy on Post-operative Pain
Condition: Low-lying Unilateral Palpable Undescended Testis
MeSH terms: Cryptorchidism
Study type: Interventional

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.
    

Intervention name(s): Scrotal Orchidopexy; Inguinal Orchidopexy
Intervention type(s): Procedure; Procedure
Intervention description(s): Single incision; Double Incision (Standard)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment