Neck Disease, Head and Neck Cancer Clinical Trial
Official title:
A Randomized Clinical Trial Comparing Output Volume Thresholds For Drain Removal After Selective Lateral Neck Dissections
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).
All adult patients (18 years old and over) undergoing unilateral SLNDs either levels I-III,
I-IV, or II-III, II-IV, or II-VA for oral cavity, oropharynx (if the resection does not
connect to the neck), thyroid, salivary gland, parotid, and skin carcinoma by one of three
Head and Neck Surgery faculty members at UCSF will be consecutively registered. A randomized
packet containing the patient's research ID number will be pulled and included into the
patient's chart. Randomization will be done at the initiation of the study by creating a
randomization list with blocking and stratification by surgeon. An envelope containing the
patients randomized group assignment will not be opened until the end of the case. The
patients will be randomized to one of two groups; drains placed routinely and removed once
output is less than 30ml over 24-hours or 15ml over 12-hours and drains placed routinely and
removed on rounds the morning of postoperative day one if output is less than 100ml total and
does not appear chylous. Exclusion criteria will be bilateral neck dissections, revision neck
dissections (prior surgery in the ipsilateral neck including excisional lymph node biopsy),
previous radiation, need for sternocleidomastoid muscle (SCM) excision, need for internal
jugular (IJ) excision, pectoralis major flap reconstruction of a ipsilateral skin defect, and
anticoagulant medications other than routine deep venous thrombosis prophylaxis with either
weight-based subcutaneous heparin or enoxaparin within 8 days postoperatively.
The procedure and postoperative care will be standardized to the degree described as follows:
One 10 French Jackson-Pratt drain will be used. All necks will be closed with 3-0 vicryl, 4-0
monocryl, and 5-0 fast absorbing sutures. All patients will receive standardized
postoperative orders including inpatient antibiotics not to exceed 24hrs (unless an infection
is suspected) and deep vein thrombosis (DVT) prophylaxis; either weight based subcutaneous
heparin or enoxaparin. The chief resident will receive an email indicating when to remove
drain. All patients will receive standardized postoperative instructions including wound care
with and without drain. A standardized physical exam will be performed on all patients every
day of inpatient stay by the chief resident and on postoperative appointment (5-8 days
post-operatively) by the attending surgeon to evaluate for clinical evidence of seroma and
hematomas.
Physical exam will specifically include:
Inspect and palpate for presence fluctuance. Inspect for color change, erythema or ecchymosis
Palpate for tenderness
All patients will be given a patient satisfaction questionnaire at their first postoperative
visit to evaluate their overall satisfaction with their hospital stay, their recovery and
healing of their wound, their comfort with home care, and level of pain. We plan to use the
validated questionnaire, the measurement of quality of recovery (QoR-40).
Outcome Assessment: The primary outcome of this study will be the presence or absence of
hematoma or seroma. Secondary outcomes will be the hospital length of stay, the need for any
additional procedures, and the quantitative outcome from the patient satisfaction
questionnaire. We will also collect data on the number of lymph nodes removed from the
pathology report, the presence of carcinoma in the lymph nodes, and the need for home health
care.
;