Haithem Aloui
Manouba, Tunis Governorate, 2010, Tunisia
NCT Number: NCT06253832
The resective-constructive surgery, detailed in prior research by Palacios-Jaraquemada JM, involves excising the placenta and its attachment on the myometrium, with modifications including the systematic use of a double JJ probe, omitting arterial ligation, and prioritizing careful dissection and reconstruction.
A prospective single-center study conducted from January 4, 2020 to February 2, 2024, at the Tunisian maternity ward including cases of placenta accreta, increta and percreta. Data on the estimation of blood loss, complications, transfusions and intensive care admissions were recorded. Diagnosis of placenta accreta was based on imaging and histopathology. The blood loss calculation incorporates total blood volume and changes in hematocrit.
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Female
Interventional
Not applicable
Manouba, Tunis Governorate, 2010, Tunisia
The surgical procedure known as resective-constructive surgery involves the excision of the placenta and its attachment site on the myometrium. This method has been detailed in prior research by Palacios-Jaraquemada JM, upon which we have built with some modifications.
Our modifications include the systematic placement of a double JJ probe under spinal anesthesia, omitting the ligation of hypogastric arteries or uterine arteries. Cesarean sections are performed at 37 weeks of gestational age. We prioritize ligating newly formed blood vessels between the uterus and surrounding structures, carefully dissecting the bladder, performing hysterotomy, and meticulously removing the placenta and its insertion bed until reaching healthy tissues. Subsequently, uterine reconstruction is undertaken.
Placental boundaries are identified through extrauterine palpation, followed by a transverse hysterotomy. Intrauterine palpation delineates the inferior margins of the placenta, guiding the resection of the placental bed. Closure is achieved through hysterorrhaphy. The JJ probe is removed post-surgery, and hemostasis is ensured through the modified B-Lynch suturing technique.
The prospective single-center study spanned from January 4, 2020, to February 2, 2024, encompassing the maternity and neonatology center in Tunis.
Data pertaining to operative time, blood loss, operative complications (such as organ or vessel injury), and postoperative complications (both early and late) were documented. Additionally, the success of the technique, units of blood transfusion administered, and admissions to the intensive care unit (ICU) were meticulously recorded.
Suspicion of placenta accreta was initially raised through pelvic MRI and ultrasonography. PAS was confirmed in all enrolled patients based on clinical history, image analysis (including ultrasound, Doppler, and MRI), and histopathological confirmation.
Patients lacking an intrasurgical or histopathological diagnosis of PAS were excluded from the statistical analysis.
Proficiency in the surgical technique, incorporating specialized hemostasis and dissection maneuvers, was attained by senior obstetricians who participated in 5-7 surgeries before independently managing cases. This approach aimed to ensure the initial reproducibility of the methodology.
The calculation of blood loss took into consideration the total blood volume (TBV), pre-partum hematocrit, and post-partum hematocrit, using the following formulas :
This approach ensured accurate assessment of blood loss during the procedures.
Sample Size:
In determining the sample size for our study, we employed a statistical formula applicable in the context of comparing mean values across two distinct groups, namely the experimental and control groups. This calculation is rooted in the t-test for independent samples.
The process entails the following critical steps:
Pilot Study:
Initially, a pilot study was conducted to ascertain the standard deviations of the two groups and to gain an insight into the expected minimum difference.
Main Study:
Post-pilot study, we estimated the sample size. The "conservative surgical treatment" group was compared with two "hysterectomy" groups, sharing similar characteristics.
Description of Surgical Technique:
Our team has developed illustrative photos of the surgical method used as well as videos.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The surgical procedure involved a midline incision for the laparotomy approach. Dissection of the uterus from the posterior bladder wall extended down to the cervix, with coagulation of the vesicouterine vessels. Hysterotomy was executed in the upper segment, just above the area of myometrial invasion. Hemostasis of the lower uterus was achieved through either square compression sutures or ligation of the colpouterine vessels. A conservative approach to uterine surgery was considered viable only under conditions of stable hemodynamics and when at least 2 cm of healthy myometrium was visibly intact above the cervix. For cases involving conservative resection, all myometrium affected by invasion and the entire placenta were excised. Subsequently, the uterus was reconstructed using a continuous stitching technique.
hysterectomy for placenta accreta spectrum
Time frame: peroperatively
Blood spoliation during procedure
Time frame: First 24 hours]
The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure
Time frame: First 24 hours
Number of red blood cells units transfused
Time frame: peroperatively
Time needed to perform surgery from incision to skin closure
Time frame: first 24 hours
Intensive care transfer following surgery for placenta accreta
Time frame: time from surgery up to 30 days postoperative
duration of the stay in the ICU following surgery for placenta accreta
Time frame: time from surgery up to 30 days postoperative
Assessed by the incidence of Intravascular disseminated coagulopathy
Time frame: Time from surgery up to 30 days postoperative
Incidence of accidental bladder damage
Time frame: Time from surgery up to 30 days postoperative
Incidence of accidental digestive lesion
Tunis University
Other
Surgical Conservative Management of Placenta Accreta Disorders
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