Clinical trial NCT06356493: Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Placenta Accreta Spectrum
Cesarean Section Complications
Keywords: haemorrhage
Placenta accreta spectrum disorder
caesarean hysterectomy
occlusion balloons
internal iliac artery
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We collected 38 patients who were divided into two groups: Group 1 (n=22), Group 2 (n=16).

Brief summary: The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.

The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders.

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 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.

Eligibility criteria: Inclusion Criteria:

* placenta accreta spectrum disorder (PASD) confirmed by histopathological examination.
* caesarean hysterectomy.

Exclusion Criteria:

* placenta accreta suspected in MRI fundings but disproved in in histopathological examination.
* conservative treatment of PASD

Primary outcomes:
measure: calculated blood loss
timeFrame: peroperatively
measure: Transfusion peroperatively
timeFrame: First 24 hours]
measure: Duration of surgery
timeFrame: peroperatively
measure: Postoperative hospital stay
timeFrame: up to 40 days postpartum
measure: Postoperative transfer to the intensive care unit
timeFrame: up to 40 days postpartum
Secondary outcomes:
measure: Morbidity
timeFrame: time from surgery up to 30 days postoperative
Other outcomes:
Locations:
city: Manouba
country: Tunisia
facility: Haithem Aloui
state: Nabeul
city: Tunis
country: Tunisia
facility: Haithem Aloui
state: Nabeul
Study officials:
affiliation: Tunis University Manar
name: Haithem Aloui, Doctor
role: PRINCIPAL_INVESTIGATOR
References: