Orthopaedics
Conditions
Interventions
Preoperative bowel cleansing enema
no intervention before percutaneous sacroiliac screw fixation
Sponsors
Orthopedics and trauma surgery department at Tikur Anbessa Specialized Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients eligible for the trial must comply with all of the following at randomization: - Age = 18 years - Currently admitted under the care of the Orthopedics and trauma surgery department of Tikur Anbessa Specialized Hospital - Unstable pelvic ring injury that requires percutaneous sacroiliac screw fixation with less than 2-week duration.
Exclusion criteria
Exclusion criteria: - Acetabular and anterior pelvic ring injury that requires fixation other than sacroiliac screw fixation - Pelvic Dysmorphism - Open pelvic fracture - Rectal injury - Preoperative lower extremity nerve injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are fluoroscopic pelvic image quality score (FPIQS) and Kerma area product (KAP or DAP) in Gycm² The fluoroscopic pelvic image quality score (FPIQS) is modified from European guidelines on quality criteria for diagnostic radiographic images of the pelvis . Fluoroscopic Pelvic Image Quality Score (FPIQS) scores the visibility of 9 important anatomic pelvic structures using a 3- point Likert scale that ranges from 0 (not visible) to 3 (excellent or well visualized) for each anatomic structure, making the total score 27. The nine structures included are sacral canal, anterior boundary of S1, and posterior boundary of S1 on inlet view. S1 foramen, S2 foramen, superior endplate, and inferior endplate of both S1 and S2 on outlet view. The image quality will be assessed in a blinding setting by two experienced orthopedic trauma surgeons on pelvic fractures. Using a three-point grading system, both readers evaluated independently the visibility of 9 anatomic structures on the sacrum; the average score will be taken as the final score out of 27. Kerma area product (KAP or DAP) in Gycm², record taken from c-arm machine Dose-area product (DAP) and currently named kerma-area product (KAP) is measured dosimetric quantity that can estimate the radiation risk. It represents the product of the dose (in mGy, cGy or Gy) at the center of a certain plane of the X-ray beam (e.g. the surface of the patient) multiplied by the area of the X-ray field at that plane (in cm² or m²). KAP provides a good index for estimating stochastic risk . | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures will be screw insertion time in minutes, total number of irradiation events, postoperative reduction quality assessed using Matta and Tornetta criteria for vertical displacement of pelvis, and postoperative lower extremity nerve injury. Screw insertion time is the time taken from the start of the surgery to completion of screw insertion measured in minutes recorded during the procedure. Total number of irradiation events is the total number of images taken during the procedure which was taken from final report of C-arm machine Postoperative reduction quality will be assessed using Matta and Tornetta criteria for vertical displacement of the hemipelvis by measuring the difference in height of the femoral heads using a postoperative AP pelvis x-ray Postoperative lower extremity nerve injury will be assessed clinically for sensation and motor activity of both lower extremities Complications from the intervention: - Extended diarrhea and abdominal cramps after a cleansing enema will be assessed by interviewing patients. | — |
Countries
Ethiopia
Contacts
Public ContactBinyam Mengistu
Orthopedic and trauma surgery resident at Tikur Anbessa Specialized Hospital
Outcome results
None listed