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临床试验/NCT06634082
NCT06634082已完成不适用

Total Extraperitoneal Approach in Orthopedic Surgery (O-TEP); Preliminary Clinical Outcomes of Symphysial Plating in Fifteen Cases: A Case Series'

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年3月1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
15
试验地点
1
主要终点
Operating Time

研究概览

简要总结

The goal of this retrospective observational study is to evaluate the preliminary clinical and functional outcomes of total extraperitoneal approach (O-TEP) symphysial plating in patients with pubic symphysis diastasis (PSD). The study involved 15 patients (90% male, mean age 40) treated between March 2022 and May 2024.

The main questions it aims to answer are:

What are the clinical outcomes (e.g., VAS scores, Iowa Pelvic Scores, Majeed scores) following O-TEP symphysial plating? What are the surgical outcomes, including operating time, blood loss, and complications, associated with this minimally invasive technique?

Participants underwent:

Total extraperitoneal endoscopic symphysial plating, with follow-up assessments including postoperative pain scores, radiographs, and functional outcome evaluations using the Iowa Pelvic and Majeed scores.

Researchers will analyze the outcomes to see if this approach offers advantages over traditional open surgery, potentially reducing complications and improving recovery in PSD patients.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with pubic symphysis diastasis (PSD).
  • Patients who underwent total extraperitoneal endoscopic symphysial plating (O-TEP) between March 2022 and May
  • Patients with a follow-up period of at least 12 months.
  • Patients who provided informed consent for the surgical procedure and the study.

排除标准

  • Patients who required conversion to open surgery during the procedure (e.g., due to pneumoperitoneum).
  • Patients with a follow-up period of less than 12 months.
  • Patients with incomplete clinical or radiological data.
  • Patients with contraindications to endoscopic surgery.
  • Patients who did not provide informed consent for the study.

结局指标

主要结局

Operating Time

时间窗: 24 hours (after surgical procedure)

Time taken to complete the surgical procedure.

Intraoperative Blood Loss

时间窗: 24 hours (after surgical procedure)

Amount of blood lost during the surgical procedure.

次要结局

  • Hospital Stay Duration(From the day of surgery until discharge (typically 2 to 4 days). Unit of Measure: Days)
  • Complications(From the day of surgery until the final follow-up (12 to 25 months). Unit of Measure: Number of patients with complications.)
  • Postoperative Pain (VAS Scores)(until the final follow-up (12 to 25 months))

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Vedat Öztürk

Specialist Doctor in Orthopedics and Traumatology

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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