Timing of Postoperative Drain Removal Following Parotidectomy - a Prospective Randomized Controlled Study
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Purpose
There is no standard of care of management following parotidectomies. Most practitioners however place a drain (usually a flat Davol closed suction drain/ Hemovac in the investigators institutions) in the wound bed at the end of the procedure, which is usually removed the day following the surgery, or when the drain output reaches a subjective number (depending on surgeon preference). The investigators hypothesis is that there is no difference in hematoma/bleeding or infection rate when post parotidectomy drains are removed in the recovery area on the day of the surgery prior to discharge, compared to drains that are kept in place for at least 1 day or until drainage is less than 50 cc/24 hrs. The investigators would therefore like to undergo a randomized control clinical trial to assess the rate of significant hematoma formation and infection, the need for readmission and length of admission secondary to these complications when comparing 2 groups: one where drains are removed prior to discharge from the recovery area and the other where the patients are discharged with the drain and seen the next post operative day in the office. The drain output will then be measured and the drain taken out.
| Condition | Intervention |
|---|---|
|
Parotidectomy |
Other: Early Drain Removal Other: Late Drain Removal |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Timing of Postoperative Drain Removal Following Parotidectomy and Its Effects on Hematoma and Infection Rate and Length of Hospital Stay- a Prospective Randomized Controlled Study |
- Rate of hematoma formation [ Time Frame: Hematoma formed within 30 days after the surgery ] [ Designated as safety issue: No ]The proportions of hematoma formation in patients with early drain removal compared to later drain removal will be assessed
- Rate of infection [ Time Frame: Within 30 days following surgery ] [ Designated as safety issue: No ]The proportion of patients having a surgical wound infection in the group with early drain removal will be compared to that in later drain removal
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Flat Davol drain
both arms will have flat davol drains placed at the end of the parotidectomy surgery
|
Other: Early Drain Removal
Drain will be removed prior to patient's discharge on the day of the surgery
Other: Late Drain Removal
Patient will be seen on the day following the surgery to have the drain removed
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged ≥ 18 years old
- Competent
- Patients undertaking unilateral or bilateral parotidectomies at Vancouver General Hospital, Vancouver; St. Paul's Hospital, Vancouver; or Surrey Memorial Hospital, Surrey.
Exclusion Criteria:
- Patients on anticoagulation therapy
- Patients classified in the preanesthetic evaluation as ASA ≥ 3, where a patient would require post operative overnight admission secondary to his comorbidities
- Immunosuppression such as concurrent radiation or chemotherapy or receiving high dose corticosteroids
- Concommitant infections requiring antibiotics
- Patients who are having additional head and neck procedures at the time of the parotidectomy, other than skin excision (eg. Modified neck dissection, mandibulectomy, external auditory canal resection)
Contacts and Locations| Contact: Veronique Wan Fook Cheung, MDCM | 604-992-7752 | veroniquewan@gmail.com |
| Contact: Donald W Anderson, MD | 604-941-9191 | dwa@shaw.ca |
| Canada, British Columbia | |
| Eagle Ridge Hospital | Not yet recruiting |
| Port Moody, British Columbia, Canada | |
| Principal Investigator: Donald W Anderson, MD | |
| Surrey Memorial Hospital | Not yet recruiting |
| Surrey, British Columbia, Canada | |
| Principal Investigator: Donald W Anderson, MD | |
| Vancouver General Hospital | Not yet recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Veronique Wan Fook Cheung, MDCM veroniquewan@gmail.com | |
| Contact: Donald W Anderson, MD 604-941-9191 dwa@shaw.ca | |
| Principal Investigator: Donald W Anderson, MD | |
| St. Paul's Hospital | Not yet recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Veronique Wan Fook Cheung, MDCM veroniquewan@gmail.com | |
| Contact: Donald W Anderson, MD 604-941-9191 dwa@shaw.ca | |
| Principal Investigator: Donald W Anderson, MD | |
| Principal Investigator: | Donald W Anderson, MD | University of British Columbia |
More Information
No publications provided
| Responsible Party: | Dr. Donald W. Anderson, University of Brtish Columbia - Vancouver Coastal Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01399021 History of Changes |
| Other Study ID Numbers: | H11-01434 |
| Study First Received: | July 19, 2011 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Parotidectomy Drain removal Timing Hematoma Surgical wound infection |
ClinicalTrials.gov processed this record on June 18, 2013