NCT03113526

Brief 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). 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2017

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

April 10, 2017

Last Update Submit

December 6, 2017

Conditions

Neck Disease, Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Seroma formation

    wound seroma

    30 days

Secondary Outcomes (1)

  • Hospital length of stay

    30 days

Study Arms (2)

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

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

Procedure: remove drain

Interventions

remove drainPROCEDURE

remove drain when output is less than 30ml or less than 100ml per 24-hour

Less than 100ml per 24-hourLess than 30ml per 24-hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • 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.

    PMID: 28837725DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • William Ryan, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

December 1, 2015

Primary Completion

January 3, 2017

Study Completion

January 11, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)