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临床试验/NCT05871645
NCT05871645已完成不适用

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

Dr Cipto Mangunkusumo General Hospital2 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
323
试验地点
2
主要终点
Intraoperative bleeding

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Jakarta Surgical Uterine Conservation (JSICA) technique

Experimental

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

干预措施: Jakarta Surgical Uterine Conservation (JSICA) Technique (Procedure)

Standard Hysterectomy

Active Comparator

Surgery to remove the uterus

干预措施: Standard Hysterectomy (Procedure)

结局指标

主要结局

Intraoperative bleeding

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 24 hours

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

次要结局

  • 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)

研究者

发起方
Dr Cipto Mangunkusumo General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amanda Rumondang

Principal Investigator

Dr Cipto Mangunkusumo General Hospital

研究点 (2)

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