DrainageNCT07390058
ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY
An observational study of Drainage and Spinal (Fusion) Surgery, run by AKİF BULUT.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drainage, Spinal (Fusion) Surgery
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged 18-80 participated in the study.
- Patients who have undergone long segment spinal surgery (2 or more segments).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Drainage, Spinal (Fusion) Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Total drainage volume
Total drainage volume until the drain is removed in patients with a thoracolumbar drain following surgery.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrainageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AKİF BULUT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AKİF BULUT, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390058
- Sponsor's protocol ID
- 2025-24/04
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESTIMATION OF INCREASED SURGICAL DRAINAGE OUTPUT FOLLOWING THORACOLUMBAR SURGERY: DRAINAGE VOLUME PREDICTION SCORE
- ClinicalTrials.gov ID
- NCT07390058
- Acronym / sponsor ID
- 2025-24/04
- Conditions
- Drainage, Spinal (Fusion) Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- AKİF BULUTUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 18-80 participated in the study.
- Patients who have undergone long segment spinal surgery (2 or more segments).
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total drainage volume
Time frame: 10 days
Total drainage volume until the drain is removed in patients with a thoracolumbar drain following surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Drainage and Spinal (Fusion) Surgery, run by AKİF BULUT.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AKİF BULUT, PhD (+905468722872, akifblt23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total drainage volume (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.