ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY

January 29, 2026 updated by: AKİF BULUT

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total drainage volume
Time Frame: 10 days
Total drainage volume until the drain is removed in patients with a thoracolumbar drain following surgery.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AKİF BULUT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-24/04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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