Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study
Primary Purpose
Placenta Accreta
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Jakarta Surgical Uterine Conservation (JSICA) Technique
Standard Hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta focused on measuring JSICA technique, Placenta Accreta, Uterine Preservation
Eligibility Criteria
Inclusion Criteria for JSICA: Focal accreta invasion ( < 50% anterior wall) Anterior invasion No parametrial or bladder invasion Residual tissue or healthy myometrium min 3 cm above the OUI or cervix Good uterine contraction post-repair (with or without compression sutures) Hemodynamically stable Exclusion Criteria: -
Sites / Locations
- Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Jakarta Surgical Uterine Conservation (JSICA) technique
Standard Hysterectomy
Arm Description
Cipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure
Surgery to remove the uterus
Outcomes
Primary Outcome Measures
Intraoperative bleeding
Intraoperative bleeding in this study was measured by the amount of blood loss (cc) and classified into < 1.000 cc, 1.000-1.500 cc, and > 1.500 cc. .
Operation duration
The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours.
Number of Patients Admitted to ICU
ICU admission was identified by the documentation of number of patients' admission to the ICU
Rate of Intraoperative complications
Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion.
Secondary Outcome Measures
Intraoperative Bleeding in JSICA compared to hysterectomy
Intraoperative bleeding in this study was measured by the amount of blood loss (cc) and classified into < 1.000 cc, 1.000-1.500 cc, and > 1.500 cc in comparison of JSICA to hysterectomy
Operation duration in JSICA compared to hysterectomy
The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours in comparison of JSICA to hysterectomy
Number of Patients Admitted to ICU in JSICA compared to hysterectomy
ICU admission was identified by the documentation of number of patients' admission to the ICU in comparison of JSICA to hysterectomy
Rate of Intraoperative complications in JSICA compared to hysterectomy
Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion in comparison of JSICA to hysterectomy
Full Information
NCT ID
NCT05871645
First Posted
February 27, 2023
Last Updated
June 5, 2023
Sponsor
Dr Cipto Mangunkusumo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05871645
Brief Title
Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study
Official Title
Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr Cipto Mangunkusumo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to present the Jakarta Surgical Uterine Conservation (JSICA) technique and its perioperative outcomes in Placenta Accreta Spectrum patients. Participants are all patients undergoing standard hysterectomy or the Jakarta Surgical Uterine Conservation (JSICA) technique. Researchers will compare both groups to see if there are any differences in the perioperative outcomes.
Detailed Description
This study uses data from Cipto Mangunkusumo General Hospital's Placenta Accreta Case Register. This register includes all patients with a confirmed placenta accreta spectrum diagnosis. Data collected includes demographic characteristics, risk factors, surgery characteristics, and perioperative outcomes. In this study, researchers would like to evaluate the perioperative outcomes of the JSICA technique in comparison to a standard hysterectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
Keywords
JSICA technique, Placenta Accreta, Uterine Preservation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jakarta Surgical Uterine Conservation (JSICA) technique
Arm Type
Experimental
Arm Description
Cipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure
Arm Title
Standard Hysterectomy
Arm Type
Active Comparator
Arm Description
Surgery to remove the uterus
Intervention Type
Procedure
Intervention Name(s)
Jakarta Surgical Uterine Conservation (JSICA) Technique
Intervention Description
a. Identifying the placenta accrete site; b. Meticulous dissection to create a bladder flap; c. Incision 1 cm above the placenta accrete; d. Fetal delivery; e. Bottom incision to resect the placenta; f. Placental delivery; g. Uterus without placenta; h. The resection area is approximated using interrupted horizontal mattress suture; i. The continuous suture used to close all incision areas; j. Evaluation of uterine contraction
Intervention Type
Procedure
Intervention Name(s)
Standard Hysterectomy
Intervention Description
The main types of hysterectomy are abdominal, vaginal, and laparoscopic hysterectomy
Primary Outcome Measure Information:
Title
Intraoperative bleeding
Description
Intraoperative bleeding in this study was measured by the amount of blood loss (cc) and classified into < 1.000 cc, 1.000-1.500 cc, and > 1.500 cc. .
Time Frame
Perioperative
Title
Operation duration
Description
The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours.
Time Frame
Perioperative
Title
Number of Patients Admitted to ICU
Description
ICU admission was identified by the documentation of number of patients' admission to the ICU
Time Frame
24 hours
Title
Rate of Intraoperative complications
Description
Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Intraoperative Bleeding in JSICA compared to hysterectomy
Description
Intraoperative bleeding in this study was measured by the amount of blood loss (cc) and classified into < 1.000 cc, 1.000-1.500 cc, and > 1.500 cc in comparison of JSICA to hysterectomy
Time Frame
Perioperative
Title
Operation duration in JSICA compared to hysterectomy
Description
The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours in comparison of JSICA to hysterectomy
Time Frame
Perioperative
Title
Number of Patients Admitted to ICU in JSICA compared to hysterectomy
Description
ICU admission was identified by the documentation of number of patients' admission to the ICU in comparison of JSICA to hysterectomy
Time Frame
24 hours
Title
Rate of Intraoperative complications in JSICA compared to hysterectomy
Description
Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion in comparison of JSICA to hysterectomy
Time Frame
Perioperative
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study apply for women with placenta accreta spectrum
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for JSICA:
Focal accreta invasion ( < 50% anterior wall)
Anterior invasion
No parametrial or bladder invasion
Residual tissue or healthy myometrium min 3 cm above the OUI or cervix
Good uterine contraction post-repair (with or without compression sutures)
Hemodynamically stable
Exclusion Criteria:
-
Facility Information:
Facility Name
Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study
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