This is a randomized study to assess the efficacy of prophylactic bilateral internal iliac artery occlusion performed prior to planned surgical management for placenta accreta spectrum (PAS). The intervention group would receive balloon occlusion, ureteric stenting and caesaeran hysterectomy while the control group would undergo the same procedure, excluding balloon occlusion. The primary outcome is to demonstrate a three pint or greater reduction in pack cell transfusion requirement.
Interventional radiology, including internal iliac artery occlusion, has been used as an adjunct in the management of placenta accreta spectrum (PAS). Retrospective studies have shown benefit in terms of reduction of blood loss. However, studies reported in literature vary widely in terms of the exact surgical procedure undertaken, in conjunction with the radiological intervention. The radiological intervention itself lacks standardization, occurring at different anatomical levels, ranging from infrarenal aortic occlusion to internal iliac or uterine artery. Furthermore, there have been reported cases of arterial thrombosis associated with arterial occlusion. We sought to clarify the effectiveness of a standardized approach , where perioperative bilateral internal iliac artery occlusion is performed followed by bilateral ureteric stenting and caesarean hysterectomy. The control group would undergo the exact procedure, excluding internal iliac artery occlusion. Patients would be randomized but neither the patient nor surgeon could be blinded. The primary outcome would be to demonstrate a three pint or greater reduction in packed cell transfusion. Secondary outcomes include a difference in estimated blood loss, additional blood product transfusion, unplanned additional surgical procedure, serious complications arising from internal iliac artery occlusion, total procedural time and early neonatal outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion
Pack cell transfusion
To detect a three pint reduction in pack cell transfusion
Time frame: First 7 days post-operatively
Other blood components
Platelets, fresh fozen plasma, cryoprecipitate
Time frame: First 7 days post-operatively
Unplanned perioperative surgical procedures
Internal iliac artery ligation, abdominal packing, relaparotomy
Time frame: First 7 days post-operatively
Complication from internal iliac occlusion
death, arterial thrombosis, aneurysm, hematoma requiring evacuation
Time frame: First 14 days post-operatively
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