Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy
Primary Purpose
Placenta Accreta
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cesarean hystrectomy
Internal iliac artery ligation
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta
Eligibility Criteria
Inclusion Criteria:
- women with suspected placenta accreta
- Scarred uterus
- Approving hysterectomy
Exclusion Criteria:
- Women needed conservative surgery
- women with coagulopathy or bleeding disorders
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
internal iliac artery ligation
No internal iliac artery ligation
Arm Description
women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy
Women undergo cesarean hysterectomy after fetal extraction
Outcomes
Primary Outcome Measures
Number of participants needed blood transfusion
number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03129035
Brief Title
Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy
Official Title
Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
internal iliac artery ligation
Arm Type
Active Comparator
Arm Description
women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy
Arm Title
No internal iliac artery ligation
Arm Type
Active Comparator
Arm Description
Women undergo cesarean hysterectomy after fetal extraction
Intervention Type
Procedure
Intervention Name(s)
Cesarean hystrectomy
Intervention Description
Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal
Intervention Type
Procedure
Intervention Name(s)
Internal iliac artery ligation
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants needed blood transfusion
Description
number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative
Time Frame
within 24 hours from surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with suspected placenta accreta
Scarred uterus
Approving hysterectomy
Exclusion Criteria:
Women needed conservative surgery
women with coagulopathy or bleeding disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy
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