ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAKİF BULUT

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-80 participated in the study.

Patients who have undergone long segment spinal surgery (2 or more segments).

Disqualifiers

Patients with developing dural rupture,

Patients under 18 or over 80 years of age,

Patients undergoing revision surgery,

Patients undergoing short segment spinal fusion,

Trial population

The study by Li et al. (2025) titled "Risk factors leading to increased postoperative drainage in patients undergoing spinal fusion surgery" (group with excessive drainage output 60%, group with low drainage output 40%) was referenced in calculating the sample size. Using the G-power 3.1.9.7 program, a Z test (Logistic regression) was performed. Assuming a 5% type I error (α), a 95% confidence level (1-α), and 0.95 power (1-β), the total sample size for high drainage output was 325 (Odds ratio (OR): 2.25). To ensure an equal number of patients in each group, 326 patients will be included in the study.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

326 Participants
are grouped into 2 trial groups
Group A: Increased total drainage
Group B: Decreased total drainage

Trial outcomes

Primary outcomes

1

Total drainage volume

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

Time frame
10 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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AKİF BULUT

Lead sponsor

Uludag University

Sponsor institution

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