Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2015-12-01
2017-01-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Less than 30ml per 24-hour
Drain removed as early as day one as long as output less than 30ml per 24-hour
remove drain
remove drain when output is less than 30ml or less than 100ml per 24-hour
Less than 100ml per 24-hour
Drain removed as early as day one as long as output less than 100ml per 24-hour
remove drain
remove drain when output is less than 30ml or less than 100ml per 24-hour
Interventions
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remove drain
remove drain when output is less than 30ml or less than 100ml per 24-hour
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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William Ryan, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF
San Francisco, California, United States
Countries
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References
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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.
Other Identifiers
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14209
Identifier Type: -
Identifier Source: org_study_id