Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion

Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion With or Without Hematuria

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

Study Overview

• Status: Recruiting
• Conditions: Placenta Accreta With Bladder Invasion
• Intervention / Treatment: Procedure: Bladder conservative surgery in placenta accretta

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed Maged; Phone Number: +201005227404; Email: dr_ahmedmaged08@kasralainy.edu.eg
• Study Contact Backup: Name: AbdAllah Mousa; Phone Number: +201274574588; Email: dr_abdallamousa@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 12111
    • Recruiting
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: conservative surgery for bladder in placenta accretta

Procedure: Bladder conservative surgery in placenta accretta; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during the operation

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Anticipated): March 9, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: 174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No