ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY

NCT07390058 | Not Yet Recruiting

• 1 other identifier: 2025-24/04
• Study Type: observational
• Target: 326
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Drainage; Spinal (Fusion) Surgery

Outcome Measures

Primary Outcomes (1)

• Total drainage volume

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

  10 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AKİF BULUT: lead

Central Study Contacts

AKİF BULUT, PhD

CONTACT

+905468722872; akifblt23@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01