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ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY

A

AKİF BULUT

Status

Begins enrollment this month

Conditions

Spinal (Fusion) Surgery
Drainage

Study type

Observational

Funder types

Other

Identifiers

NCT07390058
2025-24/04

Details and patient eligibility

About

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.

Enrollment

326 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

326 participants in 2 patient groups

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

Trial contacts and locations

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Central trial contact

AKİF BULUT, PhD

Data sourced from clinicaltrials.gov

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