Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2025-12-17 @ 2:30 PM
Study NCT ID:
NCT06356493
Status:
None
Last Update Posted:
2024-04-10 00:00:00
First Post:
2024-03-30 00:00:00
Brief Title:
Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD
Sponsor:
Tunis University
Organization:
Tunis University
Study Overview
Official Title:
Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for Placenta Accreta Spectrum Disorder Reduces Blood Loss: a Retrospective Comparative Study
Status:
None
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study population:
In the study, the population was divided into two groups:
Group1: Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries.
Group2: Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries.
Service Protocol:
All patients received dexamethasone for foetal lung maturation. Preoperative placement of prophylactic occlusion balloons of both internal iliac arteries (OBIIA) was performed at radiology department. Access to the internal iliac arteries was achieved by retrograde transcutaneous introduction of hydrophilic sheath kits of 8.5 mm under fluoroscopic guidance from both femoral arteries. Once in the lumens of the two internal iliac arteries, the radiologist inflated the balloons until blood flow ceased. The pressure at which occlusion of both internal iliac arteries was achieved was recorded for subsequent replication in the operating room. The radiologist secured the two kits to the skin and applied a compressive dressing. The patient was then directly transferred to the operating room.
General anaesthesia was preferred. Blood loss was estimated by weighing surgical sponges and drapes and quantifying aspirated blood.
Initially, a JJ stent was inserted for both groups to limit urinary tract injuries. Caesarean hysterectomy was performed through a midline infraumbilical incision. The bladder-uterine peritoneum was dissected, followed by a vertical fundal hysterotomy away from the placenta, and the foetus was delivered. Inflation of the occlusion balloons of both internal iliac arteries was performed simultaneously with extraction by the radiologist. This was followed by clamping the umbilical cord and closure of the hysterotomy while leaving the placenta in situ without any attempt at traction or delivery and without oxytocin administration.
the surgeon proceeded with the remaining steps of hysterectomy. The radiologist deflated the balloons at the end of the hysterectomy. The inflation of the OBIIA did not exceed 60 minutes. Haemostasis was verified, and an intraperitoneal drainage system was installed. A video was developed summarizing the procedure in Group 2.
In the study, the population was divided into two groups:
Group1: Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries.
Group2: Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries.
Service Protocol:
All patients received dexamethasone for foetal lung maturation. Preoperative placement of prophylactic occlusion balloons of both internal iliac arteries (OBIIA) was performed at radiology department. Access to the internal iliac arteries was achieved by retrograde transcutaneous introduction of hydrophilic sheath kits of 8.5 mm under fluoroscopic guidance from both femoral arteries. Once in the lumens of the two internal iliac arteries, the radiologist inflated the balloons until blood flow ceased. The pressure at which occlusion of both internal iliac arteries was achieved was recorded for subsequent replication in the operating room. The radiologist secured the two kits to the skin and applied a compressive dressing. The patient was then directly transferred to the operating room.
General anaesthesia was preferred. Blood loss was estimated by weighing surgical sponges and drapes and quantifying aspirated blood.
Initially, a JJ stent was inserted for both groups to limit urinary tract injuries. Caesarean hysterectomy was performed through a midline infraumbilical incision. The bladder-uterine peritoneum was dissected, followed by a vertical fundal hysterotomy away from the placenta, and the foetus was delivered. Inflation of the occlusion balloons of both internal iliac arteries was performed simultaneously with extraction by the radiologist. This was followed by clamping the umbilical cord and closure of the hysterotomy while leaving the placenta in situ without any attempt at traction or delivery and without oxytocin administration.
the surgeon proceeded with the remaining steps of hysterectomy. The radiologist deflated the balloons at the end of the hysterectomy. The inflation of the OBIIA did not exceed 60 minutes. Haemostasis was verified, and an intraperitoneal drainage system was installed. A video was developed summarizing the procedure in Group 2.
Detailed Description:
Study population
In the study the population was divided into two groups
Group1 Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries
Group2 Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries
Service Protocol
All patients received dexamethasone for foetal lung maturation Preoperative placement of prophylactic occlusion balloons of both internal iliac arteries OBIIA was performed at radiology department Access to the internal iliac arteries was achieved by retrograde transcutaneous introduction of hydrophilic sheath kits of 85 mm under fluoroscopic guidance from both femoral arteries Once in the lumens of the two internal iliac arteries the radiologist inflated the balloons until blood flow ceased The pressure at which occlusion of both internal iliac arteries was achieved was recorded for subsequent replication in the operating room The radiologist secured the two kits to the skin and applied a compressive dressing The patient was then directly transferred to the operating room
General anaesthesia was preferred Blood loss was estimated by weighing surgical sponges and drapes and quantifying aspirated blood
Initially a JJ stent was inserted for both groups to limit urinary tract injuries Caesarean hysterectomy was performed through a midline infraumbilical incision The bladder-uterine peritoneum was dissected followed by a vertical fundal hysterotomy away from the placenta and the foetus was delivered Inflation of the occlusion balloons of both internal iliac arteries was performed simultaneously with extraction by the radiologist This was followed by clamping the umbilical cord and closure of the hysterotomy while leaving the placenta in situ without any attempt at traction or delivery and without oxytocin administration
the surgeon proceeded with the remaining steps of hysterectomy The radiologist deflated the balloons at the end of the hysterectomy The inflation of the OBIIA did not exceed 60 minutes Haemostasis was verified and an intraperitoneal drainage system was installed A video was developed summarizing the procedure in Group 2
In the study the population was divided into two groups
Group1 Patients treated by caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries
Group2 Patients treated by caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries
Service Protocol
All patients received dexamethasone for foetal lung maturation Preoperative placement of prophylactic occlusion balloons of both internal iliac arteries OBIIA was performed at radiology department Access to the internal iliac arteries was achieved by retrograde transcutaneous introduction of hydrophilic sheath kits of 85 mm under fluoroscopic guidance from both femoral arteries Once in the lumens of the two internal iliac arteries the radiologist inflated the balloons until blood flow ceased The pressure at which occlusion of both internal iliac arteries was achieved was recorded for subsequent replication in the operating room The radiologist secured the two kits to the skin and applied a compressive dressing The patient was then directly transferred to the operating room
General anaesthesia was preferred Blood loss was estimated by weighing surgical sponges and drapes and quantifying aspirated blood
Initially a JJ stent was inserted for both groups to limit urinary tract injuries Caesarean hysterectomy was performed through a midline infraumbilical incision The bladder-uterine peritoneum was dissected followed by a vertical fundal hysterotomy away from the placenta and the foetus was delivered Inflation of the occlusion balloons of both internal iliac arteries was performed simultaneously with extraction by the radiologist This was followed by clamping the umbilical cord and closure of the hysterotomy while leaving the placenta in situ without any attempt at traction or delivery and without oxytocin administration
the surgeon proceeded with the remaining steps of hysterectomy The radiologist deflated the balloons at the end of the hysterectomy The inflation of the OBIIA did not exceed 60 minutes Haemostasis was verified and an intraperitoneal drainage system was installed A video was developed summarizing the procedure in Group 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None