Clinical trial · Interventional
Neck Drains for SLNDs
A Randomized Clinical Trial Comparing Output Volume Thresholds For Drain Removal After Selective Lateral Neck Dissections
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-blinded randomized controlled trial to compare the outcomes of early closed suction drain removal versus output volume-based drain removal after selective lateral neck dissections (SLND). The main hypothesis of the study is that the early drain removal of closed suction drains on the first postoperative day is safe compared to the current practice of output volume-based drain removal when output is less than 30ml/24hr or 15ml/12hr. This study will also evaluate the hypotheses that output volume-based drain removal of surgical drains increases inpatient length of stay and decreases the average patient satisfaction score on the measurement of quality of recovery (QoR-40).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neck Disease, Head and Neck Cancer | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| remove drain | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Less than 30ml per 24-hour
- description
- Drain removed as early as day one as long as output less than 30ml per 24-hour
- interventionNames
- Procedure: remove drain
- type
- ACTIVE_COMPARATOR
- label
- Less than 100ml per 24-hour
- description
- Drain removed as early as day one as long as output less than 100ml per 24-hour
- interventionNames
- Procedure: remove drain
Primary outcomes (1)
- measure
- Seroma formation
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing unilateral SLNDs either levels I-III, I-IV, II-III, or II-IV for oral cavity, oropharynx (if the resection does not connect to the neck), thyroid, salivary gland, parotid, and skin carcinoma. 2. A treatment plan involving levels I-III, I-IV, II-III, or II-IV, as recommended by National Comprehensive Cancer Network (NCCN) Guidelines 3. Patient must be 18 years of age or older. 4. The patient must have capacity to be able to sign a study-specific informed consent prior to study entry. Exclusion Criteria: 1. Pregnancy (for female patients). 2. Patients with history of prior radiation therapy or radioactive iodine to the head and neck. 3. Patients with neck dissection connected to upper aerodigestive tract. 4. Patients found to require sternocleidomastoid muscle or internal Jugular vein excision. 5. Patients who will require anticoagulant medications other than routine DVT prophylaxis within 8 days postoperatively 6. Patients undergoing bilateral neck dissection 7. Patients undergoing neck skin defect reconstruction 8. Patients with Chronic cough 9. Patients with bleeding disorders or who take aspirin regularly
References
Publications (1)
- DERIVEDTamplen ML, Tamplen J, Shuman E, Heaton CM, George JR, Wang SJ, Ryan WR. Comparison of Output Volume Thresholds for Drain Removal After Selective Lateral Neck Dissection: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Dec 1;143(12):1195-1199. doi: 10.1001/jamaoto.2017.1414. PMID 28837725