跳至主要内容
临床试验/NCT06253832
NCT06253832已完成不适用

Surgical Conservative Management of Placenta Accreta Disorders

Tunis University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Hemoglobin variation

研究概览

简要总结

The resective-constructive surgery, detailed in prior research by Palacios-Jaraquemada JM, involves excising the placenta and its attachment on the myometrium, with modifications including the systematic use of a double JJ probe, omitting arterial ligation, and prioritizing careful dissection and reconstruction.

A prospective single-center study conducted from January 4, 2020, to August 17, 2022, at the Tunisian maternity center included cases of placenta accreta and increta, excluding placenta percreta. Data on operative metrics, complications, transfusions, and ICU admissions were recorded. Diagnosis of placenta accreta spectrum (PAS) relied on imaging and histopathology, with exclusion criteria applied. Surgeons attained proficiency through supervised surgeries. Blood loss calculation incorporated total blood volume and hematocrit changes.

详细描述

The surgical procedure known as resective-constructive surgery involves the excision of the placenta and its attachment site on the myometrium. This method has been detailed in prior research by Palacios-Jaraquemada JM, upon which we have built with some modifications.

Our modifications include the systematic placement of a double JJ probe under spinal anesthesia, omitting the ligation of hypogastric arteries or uterine arteries. Cesarean sections are performed at 37 weeks of gestational age. We prioritize ligating newly formed blood vessels between the uterus and surrounding structures, carefully dissecting the bladder, performing hysterotomy, and meticulously removing the placenta and its insertion bed until reaching healthy tissues. Subsequently, uterine reconstruction is undertaken.

Placental boundaries are identified through extrauterine palpation, followed by a transverse hysterotomy. Intrauterine palpation delineates the inferior margins of the placenta, guiding the resection of the placental bed. Closure is achieved through hysterorrhaphy. Placenta percreta is not addressed in this procedure. The JJ probe is removed post-surgery, and hemostasis is ensured through the modified B-Lynch suturing technique. Postoperative bladder assessment is conducted using a physiological serum.

The prospective single-center study spanned from January 4, 2020, to August 17, 2022, encompassing the maternity and neonatology center in Tunis. Placentas diagnosed with accreta and increta were included, while cases of placenta percreta were excluded.

Data pertaining to operative time, blood loss, operative complications (such as organ or vessel injury), and postoperative complications (both early and late) were documented. Additionally, the success of the technique, units of blood transfusion administered, and admissions to the intensive care unit (ICU) were meticulously recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • All patients undergoing scheduled or emergency cesarean section for placenta accreta

排除标准

  • No signs of Placenta Accreta Spectrum upon artificial delivery

结局指标

主要结局

Hemoglobin variation

时间窗: First 24 hours]

The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure

Transfusion requirements

时间窗: First 24 hours

Number of red blood cells units transfused

Intensive care transfer rate

时间窗: first 24 hours

Intensive care transfer following surgery for placenta accreta

Estimated blood loss

时间窗: peroperatively

Blood spoliation during procedure

Procedure duration

时间窗: peroperatively

Time needed to perform surgery from incision to skin closure

次要结局

  • Clotting disorders(time from surgery up to 30 days postoperative)
  • Length of stay in ICU(time from surgery up to 30 days postoperative)
  • Bladder wound(Time from surgery up to 30 days postoperative)
  • Digestive wound(Time from surgery up to 30 days postoperative)

研究者

发起方
Tunis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haithem Aloui

university hospital assistant

Tunis University

研究点 (1)

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