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

Conditions

• ACDF Surgery

Eligibility Criteria

Sex

ALL

Age

19 Years - 75 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2025

Primary completion

Jun 30, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

360 participants (estimated)

Arms

• Arm: No-drain group
  Participants assigned to the no-drain group will have their wound closed without a drain.
• Arm: 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.

Primary Outcome Measure

Surgical Complications [ Time Frame: Post-surgery 1-2 weeks, 3 months and 6 months ]

Central Contacts

• Chris Cornett, MD
  402-559-5626
  [email protected]

Locations (1)

Find similar trials in Omaha, NE

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