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临床试验/NCT07390058
NCT07390058尚未招募不适用

ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY: DRAINAGE VOLUME PREDICTION SCORE

AKİF BULUT0 个研究点目标入组 326 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
326
主要终点
Total drainage volume

研究概览

简要总结

In a study involving neurosurgeons worldwide, it was reported that most surgeons preferred the use of drains (186, 80.5%) and subfascial drains (169, 73.2%), with 52.87% of surgeons discontinuing drains based on time and 27.7% based on drainage volume (Cabrera et al. 2025). While the Enhanced Recovery After Surgery (ERAS) protocol does not recommend routine wound drainage for short-segment lumbar fusion surgery (Evidence Level Moderate, Recommendation Strength), the timing of drainage termination is based on drainage output (if drainage is below 50 ml) or based on postoperative days (day 2) (Han et al., 2024; Smith et al., 2019). We believe that further studies are needed to determine which patient groups require drains preoperatively and how long drains should remain in place postoperatively. This study, which aims to predict the amount of drainage during the perioperative period, will attempt to predict both the selective use of drains and how long to wait before discontinuing drainage in patients with drains. Lumbar subcutaneous fat thickness, previously used as a predictor of surgical site infections, will be tested for the first time in our study to determine whether it is a predictor of drainage output.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-80 participated in the study.
  • Patients who have undergone long segment spinal surgery (2 or more segments).

排除标准

  • Patients with developing dural rupture,
  • Patients under 18 or over 80 years of age,
  • Patients undergoing revision surgery,
  • Patients undergoing short segment spinal fusion,
  • Patients using drains other than standard-volume closed suction drainage,
  • Patients with missing data,
  • Patients experiencing mechanical problems with the drain.

研究组 & 干预措施

Increased total drainage

In the study, increased total drainage is defined as a total drainage amount of 317 ml or more at the end of the drainage termination day.

Decreased total drainage

Decreased total drainage is defined as a total drainage amount of less than 317 ml at the end of the drainage termination day.

结局指标

主要结局

Total drainage volume

时间窗: 10 days

Total drainage volume until the drain is removed in patients with a thoracolumbar drain following surgery.

次要结局

未报告次要终点

研究者

发起方
AKİF BULUT
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

AKİF BULUT

Assistant Investigator

Uludag University

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