Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion
Primary Purpose
Placenta Accreta With Bladder Invasion
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bladder conservative surgery in placenta accretta
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta With Bladder Invasion
Eligibility Criteria
Inclusion Criteria:
- Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
- patient's informed consent about the future risks of conservative management
- pregnancy > 20 weeks
Exclusion Criteria:
* deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm
- cases with total invasion in which the area of invasion is more than 20 min diameter
- patient refusing conservative management and opting for hysterectomy
- medical comorbidities making massive hemorrhage more likely such as coagulopathies
- patient is in active antepartum hemorrhage
Sites / Locations
- Kasr Alainy medical schoolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
conservative surgery for bladder in placenta accretta
Arm Description
Outcomes
Primary Outcome Measures
intraoperative blood loss
Blood loss = estimated blood volume (EBV) x preoperative hematocrit - postoperative hematocrit/preoperative hematocrit another method by weighing the towels and dressings before and after the procedure and adding the volume of fluid inside the suction apparatus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04263753
Brief Title
Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion
Official Title
Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion With or Without Hematuria
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
March 9, 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Placental borders and mapping by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively . bladder peritoneal dissection till the level of internal Os Uterus is incised away from the placenta
Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding . Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped . Then we proceed to systemically devascularize the uterus with the placenta in site After control of both superior vesical vessels Finding a fresh noninvaded plan between isthmocervical junction and posterior bladder wall aided by filling the bladder 150 cc saline Then cervical stump control sutures and severing the specimen above the clamps
Now the placenta is only attached to the bladder , apply intestinal clamp or foley cath on the bladder below the level of invasion if feasible to reduce bleeding
cut through the placenta, heavy back flow bleeding of old blood stored in the placenta will be noticed , but there is no hemodynamic change since the cervical stump is already severed
, dissect the bladder with a large safety margin cutting through the placenta.. Then in cases with hematuria saline irrigation of the bladder is usually enough to clear the hematuria 15 out of 20 In cases with larger blood clots in the bladder cystoscope is done avoiding the need for cystotomy
lastly removal of excessive placental tissues from the bladder wall by gentle swabbing or trimming, then individual control of bleeders and plication of the invaded area with seromuscular purse string sutures around said area , in cases of large areas , bladder mobilization is imperative to increase bladder capacity
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta With Bladder Invasion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conservative surgery for bladder in placenta accretta
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bladder conservative surgery in placenta accretta
Intervention Description
After control of both superior vesical vessels Finding a fresh noninvaded plan between isthmocervical junction and posterior bladder wall aided by filling the bladder 150 cc saline Then cervical stump control sutures and severing the specimen above the clamps
* Now the placenta is only attached to the bladder , apply intestinal clamp or foley cath on the bladder below the level of invasion if feasible to reduce bleeding
* cut through the placenta, heavy back flow bleeding of old blood stored in the placenta will be noticed , but there is no hemodynamic change since the cervical stump is already severed
, dissect the bladder with a large safety margin cutting through the placenta.. Then in cases with hematuria saline irrigation of the bladder is usually enough to clear the hematuria 15 out of 20
Primary Outcome Measure Information:
Title
intraoperative blood loss
Description
Blood loss = estimated blood volume (EBV) x preoperative hematocrit - postoperative hematocrit/preoperative hematocrit another method by weighing the towels and dressings before and after the procedure and adding the volume of fluid inside the suction apparatus
Time Frame
during the operation
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
patient's informed consent about the future risks of conservative management
pregnancy > 20 weeks
Exclusion Criteria:
* deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm
cases with total invasion in which the area of invasion is more than 20 min diameter
patient refusing conservative management and opting for hysterectomy
medical comorbidities making massive hemorrhage more likely such as coagulopathies
patient is in active antepartum hemorrhage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed Maged
Phone
+201005227404
Email
dr_ahmedmaged08@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
AbdAllah Mousa
Phone
+201274574588
Email
dr_abdallamousa@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed maged
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion
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