Skip to main content
Clinical Trials/NCT05871645
NCT05871645CompletedNot Applicable

Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study

Dr Cipto Mangunkusumo General Hospital2 sites in 1 country323 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
323
Locations
2
Primary Endpoint
Intraoperative bleeding

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

  • Not provided

Arms & Interventions

Jakarta Surgical Uterine Conservation (JSICA) technique

Experimental

Cipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure

Intervention: Jakarta Surgical Uterine Conservation (JSICA) Technique (Procedure)

Standard Hysterectomy

Active Comparator

Surgery to remove the uterus

Intervention: Standard Hysterectomy (Procedure)

Outcomes

Primary Outcomes

Intraoperative bleeding

Time Frame: Perioperative

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

Time Frame: Perioperative

The operation duration was the time interval from skin incision to closure (hours) and classified into \< 3 hours and \> 3 hours.

Rate of Intraoperative complications

Time Frame: Intraoperative

Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion.

Number of Patients Admitted to ICU

Time Frame: 24 hours

ICU admission was identified by the documentation of number of patients' admission to the ICU

Secondary Outcomes

  • Rate of Intraoperative complications in JSICA compared to hysterectomy(Perioperative)
  • Number of Patients Admitted to ICU in JSICA compared to hysterectomy(24 hours)
  • Intraoperative Bleeding in JSICA compared to hysterectomy(Perioperative)
  • Operation duration in JSICA compared to hysterectomy(Perioperative)

Investigators

Sponsor
Dr Cipto Mangunkusumo General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amanda Rumondang

Principal Investigator

Dr Cipto Mangunkusumo General Hospital

Study Sites (2)

Loading locations...

Similar Trials