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

Not Applicable

Completed

• Conditions: Placenta Accreta
• Interventions: Procedure: Standard Hysterectomy; Procedure: Jakarta Surgical Uterine Conservation (JSICA) Technique

• Registration Number: NCT05871645
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-05-20
• Study First Posted: 2023-05-23
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 323

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Standard Hysterectomy	Standard Hysterectomy	Surgery to remove the uterus
Jakarta Surgical Uterine Conservation (JSICA) technique	Jakarta Surgical Uterine Conservation (JSICA) Technique	Cipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure

Primary Outcome Measures

Name	Time	Method
Intraoperative bleeding	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	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	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	24 hours	ICU admission was identified by the documentation of number of patients' admission to the ICU

Secondary Outcome Measures

Name	Time	Method
Rate of Intraoperative complications in JSICA compared to hysterectomy	Perioperative	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
Number of Patients Admitted to ICU in JSICA compared to hysterectomy	24 hours	ICU admission was identified by the documentation of number of patients' admission to the ICU in comparison of JSICA to hysterectomy
Intraoperative Bleeding in JSICA compared to hysterectomy	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 in comparison of JSICA to hysterectomy
Operation duration in JSICA compared to hysterectomy	Perioperative	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

Trial Locations

Locations (1)

Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia