Neck Disease, Head and Neck CancerSLNDsNCT03113526
Neck Drains for SLNDs
A study testing remove drain in people with Neck Disease, Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Disease, Head and Neck Cancer
- What is being tested?
- remove drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 11 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patients undergoing neck skin defect reconstruction
- Patients with Chronic cough
- Patients with bleeding disorders or who take aspirin regularly
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Neck Disease, Head and Neck Cancer
- Being tested
- remove drain
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remove drainProcedure or surgery
remove drain when output is less than 30ml or less than 100ml per 24-hour
| Study group | Role | What they receive |
|---|---|---|
| Less than 30ml per 24-hour | Active comparator | Drain removed as early as day one as long as output less than 30ml per 24-hour Receives: Procedure: remove drain |
| Less than 100ml per 24-hour | Active comparator | Drain removed as early as day one as long as output less than 100ml per 24-hour Receives: Procedure: remove drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma formation
wound seroma
Measured: 30 days
Secondary outcomes (1)
Hospital length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Dec 2015
- Primary completion3 Jan 2017
- Study completion11 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck Disease, Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Ryan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113526
- Sponsor's protocol ID
- 14209
- Acronym
- SLNDs
- Status last verified
- Dec 2017
- First submitted
- 10 Apr 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28837725
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Output Volume Thresholds For Drain Removal After Selective Lateral Neck Dissections
- ClinicalTrials.gov ID
- NCT03113526
- Acronym / sponsor ID
- SLNDs / 14209
- Conditions
- Neck Disease, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 11 Jan 2017 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less than 30ml per 24-hour | Active comparator | Procedure: remove drainDrain removed as early as day one as long as output less than 30ml per 24-hour |
| Less than 100ml per 24-hour | Active comparator | Procedure: remove drainDrain removed as early as day one as long as output less than 100ml per 24-hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remove drainremove drain when output is less than 30ml or less than 100ml per 24-hour | Procedure or surgery | Less than 100ml per 24-hour, Less than 30ml per 24-hour |
Primary outcome
Seroma formation
Time frame: 30 days
wound seroma
1 secondary outcome
Hospital length of stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Derived from this study: PubMed 28837725Tamplen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Ryan, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remove drain in people with Neck Disease, Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma formation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.