Bladder Conservative Surgery in r Abnormally Invasive Placenta With Bladder Invasion

NCT ID: NCT04263753

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2022-04-30

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

Conditions

Placenta Accreta With Bladder Invasion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conservative surgery for bladder in placenta accretta

Group Type: EXPERIMENTAL

Bladder conservative surgery in placenta accretta

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed maged

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Kasr Alainy medical school

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ahmed Maged

Role: CONTACT

dr_ahmedmaged08@kasralainy.edu.eg

+201005227404

AbdAllah Mousa

Role: CONTACT

dr_abdallamousa@yahoo.com

+201274574588

Facility Contacts

Ahmed Maged, MD

Role: primary

prof.ahmedmaged@gmail.com

01005227404

Other Identifiers

174

Identifier Type: -

Identifier Source: org_study_id