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临床试验/NCT06023381
NCT06023381已完成不适用

Sliding Sign in Third-trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat Cesarean Section

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
The association between a negative sliding sign and severe adhesions

研究概览

简要总结

Predicting the presence of severe adhesions may also assist clinically in several ways: first, it allows allocation of more complicated surgeries to experienced surgeons; second, the surgeons can plan and prepare better for the surgery if they know in advance whether they are going to operate a complicated surgery; third, a difficult surgery may be scheduled to be performed in an experienced center, preparing cross match blood units, and alerting the general surgeon and urologist of the potential risk for surgical complications, saving time if intervention is required.

This information can permit preoperative planning by a multidisciplinary team of surgeons and allow the patient to be informed of the potentially high risk of complications.

详细描述

The incidence of repeat cesarean delivery is on the rise worldwide, approximately 90% of women with a prior cesarean delivery undergo a planned repeat cesarean delivery in their next pregnancy.

Post-cesarean adhesions are a major complication in subsequent surgeries, causing an increased risk for bladder and bowel injury (0.1-0.3%), hemorrhage (0.1-1.4%), infection (0.4-1.6%), and even hysterectomy (0.1-1.4%).

In addition to the risk associated with the pelviabdominal surgical procedure itself, adhesiolysis may result in injury to adjacent viscera, blood loss, and in case of emergency cesarean delivery, to the perinatal adverse outcome associated with delayed delivery of the neonate. This represents a considerable healthcare issue, as it has a significant impact both on the patient, increasing morbidity and mortality, and on healthcare costs. It is therefore important for surgeons to detect patients at high risk of having adhesions.

Women suspected to have severe intra-abdominal adhesions may benefit from appropriate preparation of blood products, better assignment of surgeons, request for preoperative surgical assistance of other medical specialties, and possibly performance of a midline skin incision to enter the peritoneal cavity. It is therefore important for surgeons to detect patients at high risk of having adhesions.

Various means have been proposed to predict adhesions prior to surgery, including analysis of patient characteristics and appearance of the scar, as well as the intraoperative peritoneal adhesion index.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • History of previous cesarean section.
  • Gestational age: Full-Term.
  • Scheduled to undergo elective cesarean section.

排除标准

  • Body mass index more than 40 on admission.
  • Abnormal placental invasion.
  • Having known collagen disease.
  • Unplanned or emergency repeated cesarean delivery.
  • History of abdominal surgery.

结局指标

主要结局

The association between a negative sliding sign and severe adhesions

时间窗: 24 hours

through transabdominal ultrasound

次要结局

  • hemoglobin drop greater than 3 g/dL(24 hours)
  • Intestinal injury(24 hours)
  • The association between a negative sliding sign and operative time(24 hours)
  • Urinary Bladder injury(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Al Shirbiny Hamed Esmail

Principal Investigator

Ain Shams Maternity Hospital

研究点 (1)

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