Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy

NCT ID: NCT03129035

Last Updated: 2017-04-26

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2018-02-28

Brief Summary

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All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention

Detailed Description

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All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention.

Midline incision in the all patients is preferred. The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin.

Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side.

Conditions

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Placenta Accreta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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internal iliac artery ligation

women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy

Group Type ACTIVE_COMPARATOR

Cesarean hystrectomy

Intervention Type PROCEDURE

Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal

Internal iliac artery ligation

Intervention Type PROCEDURE

The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin. Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side

No internal iliac artery ligation

Women undergo cesarean hysterectomy after fetal extraction

Group Type ACTIVE_COMPARATOR

Cesarean hystrectomy

Intervention Type PROCEDURE

Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal

Interventions

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Cesarean hystrectomy

Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal

Intervention Type PROCEDURE

Internal iliac artery ligation

The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin. Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women with suspected placenta accreta
* Scarred uterus
* Approving hysterectomy

Exclusion Criteria

* Women needed conservative surgery
* women with coagulopathy or bleeding disorders
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

01005227404

Other Identifiers

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4

Identifier Type: -

Identifier Source: org_study_id

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