Abnormal Placentation, Bladder Injury, Cesarean Hysterectomy, Placenta Accreta Spectrum, Urinary Tract Injury
Conditions
Keywords
Placenta Accreta Spectrum, Cesarean Hysterectomy, Methylene Blue, Bladder Filling, Bladder Injury, Ureteric Injury, Surgical Complications
Brief summary
This prospective cohort study aims to evaluate whether preoperative bladder filling with methylene blue dye can reduce the incidence of urinary tract injuries during cesarean hysterectomy in patients diagnosed with placenta accreta spectrum. A total of 60 patients will be randomly assigned to either an intervention group receiving methylene blue bladder instillation or a control group receiving standard surgical care. The primary outcome is the rate of intraoperative urinary tract injuries. Secondary outcomes include total operative time, , and pre and post operative hemoglobin level , number of units of packed RBCs transfused, number of units of fresh frozen plasma transfused, number of participants admitted to ICU postoperatively,number of participants with postoperative complications, duration of hospital stay of participants.
Interventions
PROCEDUREThe bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter
The bladder was filled with 300 ml diluted methylene blue (in normal saline) via Foley's catheter before uterine incision or bladder dissection to help determine the borders better and enable dissection of the lower uterine segment without excessive bleeding or unintended Bladder kept distended during dissection.
Sponsors
Usama Ahmed Elsaeed Salem, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-45 years * Pregnant women diagnosed antenatally with placenta accreta spectrum (PAS). * Pregnant women with history of previous one or more caesarian deliveries . * Planned cesarean hysterectomy at ≥33 weeks of gestation. * Singleton pregnancy. * BMI \<35 kg/m² * Suitable for standardized General anaesthesia
Exclusion criteria
* Previous bladder surgery or known urologic abnormalities. * Bleeding tendency disorder * Renal failure . * Allergy to methylene blue dye. * Emergency hysterectomy without time for protocol preparation. * Conservative uterine- preservation management. * Refusal or inability to provide informed written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of patients with intraoperative urinary tract injuries (bladder, ureters). | Intraoperative (Day 0) to 24 hours post operatively. | Number and percentage of patients with bladder or ureteric injury confirmed intraoperatively by direct visualization or intraoperative dye testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative hospital stay : Number of days from surgery to discharge . | Number of days from surgery to discharge (up to 14 days). | Number of days of hospital stay from surgery to discharge (up to 14 days). |
| Preoperative Hemoglobin recorded in g/dl | within 24 hours before surgery | Venous sample obtained within 24 hours before surgery;Analyzed using the hospital's hematology analyzer; results recorded in g/dL. |
| Total number of Units of Packed Red Blood Cells (PRBC) Transfused | from surgery start to 24 hours postoperatively | Total units from surgery start to 24 hours postoperatively, following a standardized transfusion protocol based on predefined hemoglobin thresholds, hemodynamic status, and coagulation parameters. |
| Total number of Units of Fresh Frozen Plasma (FFP) Transfused | from surgery start to 24 hours postoperatively | Total units from surgery start to 24 hours postoperatively, given for abnormal coagulation (PT/aPTT \>1.5× normal), suspected coagulopathy, or massive transfusion activation. |
| Total Operative time (minutes) | Measured in minutes from skin incision to closure. | — |
| Postoperative Hemoglobin recorded in g/dl | within 24 hours after surgery completion | Venous sample obtained within 24 hours after surgery completion; earlier if major bleeding or hemodynamic instability occurred. Same analyzer used for consistency. |
| Number of participants with postoperative complications | From time of surgery until hospital discharge (up to 14 days). | Postoperative complications were recorded for each participant from the time of surgery until hospital discharge. Complications included pelvic hematoma and whether or not need relaparotomy , urinoma , thromboembolic events, ileus, and any other clinically significant adverse events documented in the patient's chart |
| Number and percentage of patients admitted to ICU postoperatively. | Postoperatively during hospital stay up to 14 days postoperative. | — |
Countries
Egypt
Outcome results
None listed