Neck Drains for SLNDs (SLNDs)

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).

Study Overview

• Status: Completed
• Conditions: Neck Disease, Head and Neck Cancer
• Intervention / Treatment: Procedure: remove drain

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • UCSF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Less than 30ml per 24-hour; Drain removed as early as day one as long as output less than 30ml per 24-hour	Procedure: remove drain; remove drain when output is less than 30ml or less than 100ml per 24-hour
Active Comparator: Less than 100ml per 24-hour; Drain removed as early as day one as long as output less than 100ml per 24-hour	Procedure: remove drain; remove drain when output is less than 30ml or less than 100ml per 24-hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma formation	wound seroma	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital length of stay	30 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: William Ryan, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Tamplen 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): January 3, 2017
• Study Completion (Actual): January 11, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 14209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No