Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion

NCT ID: NCT05752513

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-05-01

Brief Summary

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Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups

* Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without ligation of anterior division of internal iliac artery before cesarean section.
* Group 2: included 18 pregnant women scheduled for bladder last cesarean hysterectomy with or without ligation of anterior division of internal iliac artery.

Detailed Description

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Conditions

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Placenta Accreta Spectrum Cesarean Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group 1

18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta

Group Type PLACEBO_COMPARATOR

early bladder dissection

Intervention Type PROCEDURE

The bladder dissection is early as in classic cesarean hysterectomy

Group 2

18 pregnant women scheduled for bladder last cesarean hysterectomy

Group Type EXPERIMENTAL

Late bladder dissection

Intervention Type PROCEDURE

The bladder dissection is reserved as the last step of the cesarean hysterectomy with excellent dissection of the ureteric course till the ureteric tunnel to reduce the incidence of inadvertent ureteric clamping during uterine vessel ligating and transection

Interventions

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Late bladder dissection

The bladder dissection is reserved as the last step of the cesarean hysterectomy with excellent dissection of the ureteric course till the ureteric tunnel to reduce the incidence of inadvertent ureteric clamping during uterine vessel ligating and transection

Intervention Type PROCEDURE

early bladder dissection

The bladder dissection is early as in classic cesarean hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age: reproductive age.
2. Pregnant with singleton living fetus.
3. Previous one or more cesarean sections.
4. Gestational age: \> 34 weeks.
5. Elective or non-emergency cesarean sections.
6. Preoperative hemoglobin more than 9.5 gm/dl.

Exclusion Criteria

Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abdalla Mousa

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdalla Mousa, Lecturer

Role: CONTACT

01277664430

Facility Contacts

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Ahmed Rashwan

Role: primary

01002592250

Other Identifiers

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MS-345-2022

Identifier Type: -

Identifier Source: org_study_id

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