Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement

Post-operative Outcomes Comparing Drain vs No Drain Placement Following Anterior Cervical Discectomy and Fusion Surgery

Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. The primary aim of ACDF is to alleviate neck, shoulder, and upper extremity pain associated with degenerative cervical disc disease by removing one or more affected discs, decompressing the nerves, and restoring cervical spine anatomy through the implantation of structural allograft/autograft bone or artificial spacers, plates, and screws. Historically, ACDF has demonstrated substantial long-term benefits in pain relief and quality of life improvements for patients. In the United States alone, the annual number of ACDF procedures exceeds 150,000 and is projected to rise significantly over the next four decades. Despite its technical complexity, ACDF is considered a relatively safe procedure. Common postoperative complications include dysphagia (1.7-9.5%), hematoma (0.4-5.6%), worsening myelopathy (0.2-3.3%), recurrent laryngeal nerve palsy (0.9-3.1%), cerebrospinal fluid leakage (0.5-1.7%), and surgical site infections (0.9-1.6%). One strategy employed to mitigate postoperative complications such as hematoma, surgical site infection, and the need for reoperation is the placement of an indwelling subfascial drain within the surgical site. These drains facilitate the removal of accumulated blood or serous fluid, thereby reducing localized pressure and potentially preventing adverse outcomes. Despite its theoretical benefits, the utility of subfascial drains remains a topic of debate among surgeons. Given the limited evidence on the efficacy of subfascial drain placement following ACDF, this study proposes a randomized controlled trial to evaluate the necessity and impact of subfascial drain placement on postoperative outcomes.

This study will determine whether subfascial drain placement reduces the incidence of postoperative complications, including hematoma, infection, airway compromise and secondary surgeries, compared to no drain placement following ACDF surgery; assess the impact of subfascial drain placement on the severity and duration of postoperative dysphagia compared to no drain placement; and evaluate participant-reported outcomes and satisfaction, including postoperative pain and recovery experience, between the drain and no-drain groups.

Study Overview

• Status: Not yet recruiting
• Conditions: ACDF Surgery
• Intervention / Treatment: Device: Drain

Detailed Description

Anterior Cervical Discectomy and Fusion (ACDF) is a widely performed surgical procedure used to treat cervical spondylosis and cervical disc herniations with cervical nerve root compression and or cervical spinal cord compression when conservative treatment options have been exhausted. The primary aim of ACDF is to alleviate neck, shoulder, and upper extremity pain associated with degenerative cervical disc disease by removing one or more affected discs, decompressing the nerves, and restoring cervical spine anatomy through the implantation of structural allograft/autograft bone or artificial spacers, plates, and screws. Historically, ACDF has demonstrated substantial long-term benefits in pain relief and quality of life improvements for patients. In the United States alone, the annual number of ACDF procedures exceeds 150,000 and is projected to rise significantly over the next four decades. Despite its technical complexity, ACDF is considered a relatively safe procedure. Common postoperative complications include dysphagia (1.7-9.5%), hematoma (0.4-5.6%), worsening myelopathy (0.2-3.3%), recurrent laryngeal nerve palsy (0.9-3.1%), cerebrospinal fluid leakage (0.5-1.7%), and surgical site infections (0.9-1.6%). One strategy employed to mitigate postoperative complications such as hematoma, surgical site infection, and the need for reoperation is the placement of an indwelling subfascial drain within the surgical site. These drains facilitate the removal of accumulated blood or serous fluid, thereby reducing localized pressure and potentially preventing adverse outcomes. Despite its theoretical benefits, the utility of subfascial drains remains a topic of debate among surgeons. Given the limited evidence on the efficacy of subfascial drain placement following ACDF, this study proposes a randomized controlled trial to evaluate the necessity and impact of subfascial drain placement on postoperative outcomes.

This study will determine whether subfascial drain placement reduces the incidence of postoperative complications, including hematoma, infection, airway compromise and secondary surgeries, compared to no drain placement following ACDF surgery; assess the impact of subfascial drain placement on the severity and duration of postoperative dysphagia compared to no drain placement; and evaluate participant-reported outcomes and satisfaction, including postoperative pain and recovery experience, between the drain and no-drain groups. Up to 360 participants will be randomly assigned to one of two groups. Those signed to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours. Those in the no-drain group will have their wound closed without a drain. All other aspects of participants' care before and after surgery will be the same. No additional visits are required for this study. Basic information will be collected from participants' medical records, such as age, gender, type of surgery. For 180 days following surgery, participants' health will be monitored through clinical visit notes, phone calls with their doctor or clinic staff, and records of any hospital visits due to complications.

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Chris Cornett, MD; Phone Number: 402-559-5626; Email: chris.cornett@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
      • Contact: Chris Cornett, MD; Phone Number: 402-559-5626; Email: chris.cornett@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Eligible participants scheduled to undergo a primary or revision single or multilevel anterior cervical discectomy and fusion (ACDF).

Description

Inclusion Criteria:

• 19-75 years of age
• Having elective anterior cervical discectomy and fusion (ACDF) surgery

Exclusion Criteria:

• Unable to stop anticoagulation medication
• Cervical (neck) cancer or tumor
• Combined anterior cervical discectomy and fusion, and posterior cervical fusion
• Active infection or trauma

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No-drain group; Participants assigned to the no-drain group will have their wound closed without a drain.
Drain group; Participants assigned to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours.	Device: Drain; Participants assigned to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Complications	Complications such as hematoma, infection, airway-compromise, and other complications will be recorded and monitored immediately after surgery and at followed-up visits, 1-2 weeks, 3 months and 6 months.	Post-surgery 1-2 weeks, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia Assessment EAT-10	Dysphagia, the difficulty swallowing foods or liquids, will be assessed assessed at 1-2 weeks, 3 months and 6 months,using EAT-10 assessment tool. This tool has ten questions that are rated from 0 (no problem) to 4 (severe problem). Scores of 3 or above are considered abnormal.	Post-surgery 1-2 weeks, 3 months and 6 months
Length of Hospital Stay	The total length of the post-surgical hospital stay will be obtained from medical records.	Post-surgery typically up to 1 week
Post-operative Pain Assessment	Post-operative pain will be assessed using the self-reported numerical scale (0 - no pain, 10 - worst pain imaginable) at 1-2 weeks, 3 months and 6 months.	Post-surgery 1-2 weeks, 3 months and 6 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Chris Cornett, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ACDF Surgery
• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Drainage
• Other Study ID Numbers: 0199-25-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No