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

NCT06938607 | Not Yet Recruiting

• 1 other identifier: 0199-25-FB
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACDF Surgery

Keywords

ACDF Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dysphagia Assessment EAT-10

  Post-surgery 1-2 weeks, 3 months and 6 months

• Length of Hospital Stay

  Post-surgery typically up to 1 week

• Post-operative Pain Assessment

  Post-surgery 1-2 weeks, 3 months and 6 months

Study Arms (2)

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

Interventions

Drain DEVICE

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.

Drain group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Chris Cornett, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Cornett, MD

CONTACT

402-559-5626; chris.cornett@unmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)