Neck Drains for SLNDs

Completed · Not applicable

Conditions studied: Neck Disease, Head and Neck Cancer

In brief

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).

Key facts

Study ID

NCT03113526

Run by

University of California, San Francisco

People needed

53

Starts

2015-12-01

Expected to finish

2017-01-11

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• A treatment plan involving levels I-III, I-IV, II-III, or II-IV, as recommended by National Comprehensive Cancer Network (NCCN) Guidelines
• Patient must be 18 years of age or older.
• The patient must have capacity to be able to sign a study-specific informed consent prior to study entry.

You may not qualify if…

• Pregnancy (for female patients).
• Patients with history of prior radiation therapy or radioactive iodine to the head and neck.
• Patients with neck dissection connected to upper aerodigestive tract.
• Patients found to require sternocleidomastoid muscle or internal Jugular vein excision.
• Patients who will require anticoagulant medications other than routine DVT prophylaxis within 8 days postoperatively
• Patients undergoing bilateral neck dissection
• Patients undergoing neck skin defect reconstruction
• Patients with Chronic cough
• Patients with bleeding disorders or who take aspirin regularly

Where it is running

• UCSF — San Francisco, California, United States

Full record on ClinicalTrials.gov

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