Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06253832 |
Other study ID # |
CMNT PAS |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 4, 2020 |
Est. completion date |
January 30, 2024 |
Study information
Verified date |
February 2024 |
Source |
Tunis University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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 August 17, 2022, at the
Tunisian maternity center included cases of placenta accreta and increta, excluding placenta
percreta. Data on operative metrics, complications, transfusions, and ICU admissions were
recorded. Diagnosis of placenta accreta spectrum (PAS) relied on imaging and histopathology,
with exclusion criteria applied. Surgeons attained proficiency through supervised surgeries.
Blood loss calculation incorporated total blood volume and hematocrit changes.
Description:
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. Placenta
percreta is not addressed in this procedure. The JJ probe is removed post-surgery, and
hemostasis is ensured through the modified B-Lynch suturing technique. Postoperative bladder
assessment is conducted using a physiological serum.
The prospective single-center study spanned from January 4, 2020, to August 17, 2022,
encompassing the maternity and neonatology center in Tunis. Placentas diagnosed with accreta
and increta were included, while cases of placenta percreta were excluded.
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 :
- Total Calculated Blood Loss (in milliliters of red blood cells) = Total blood volume *
Percentage of blood loss
- Total Blood Volume = 0.75 x {[height (in inches) x 50] + [weight (in pounds) x 25]}
- Percentage of Blood Loss = (pre-partum hematocrit - post-partum hematocrit) / pre-partum
hematocrit.
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:
1. Establishing the Significance Level (Alpha): Set at 0.05 to ensure 95% confidence.
2. Selecting the Study's Power (1 - Beta): Predetermined at 90%.
3. Assessing the Standard Deviations of Both Groups: Derived from pilot study data.
4. Identifying the Minimum Clinically Significant Difference (Delta): This represents the
smallest difference we aim to detect in our study.
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 formulated illustrative diagrams of the employed surgical method.