Timing of Postoperative Drain Removal Following Parotidectomy - a Prospective Randomized Controlled Study
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|ClinicalTrials.gov Identifier: NCT01399021|
Recruitment Status : Unknown
Verified July 2011 by University of British Columbia.
Recruitment status was: Not yet recruiting
First Posted : July 21, 2011
Last Update Posted : July 21, 2011
|First Submitted Date ICMJE||July 19, 2011|
|First Posted Date ICMJE||July 21, 2011|
|Last Update Posted Date||July 21, 2011|
|Study Start Date ICMJE||July 2011|
|Estimated Primary Completion Date||June 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Rate of hematoma formation [ Time Frame: Hematoma formed within 30 days after the surgery ]
The proportions of hematoma formation in patients with early drain removal compared to later drain removal will be assessed
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Rate of infection [ Time Frame: Within 30 days following surgery ]
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
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Timing of Postoperative Drain Removal Following Parotidectomy - a Prospective Randomized Controlled Study|
|Official Title ICMJE||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|
|Brief Summary||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.|
Parotidectomies involve the removal of all or a portion of the parotid gland off the facial nerve in the case of superficial parotidectomies, and total removal of the gland in the case of total parotidectomies. The most common indications for this procedure are for benign neoplasms such as pleomorphic adenomas, oncocytomas and Warthin tumors, or for malignant involvement of the gland such as metastatic cutaneous squamous cell carcinomas. Hematoma formation or bleeding following parotidectomy is a less emphasized early complication of this procedure, usually secondary to unrecognized incomplete hemostasis prior to incision closure. Hematoma formation rate post parotidectomy has been reported to vary between 3.8% (Upton et al.) and 6.1% (Laccourreye et al.). In case of bleeding or rapidly expanding hematomas, the patient is usually brought back to the operating room for surgical drainage of the hematoma and surgical control of any identified bleeding vessels (Myers et al). Small hematomas can usually be managed expectantly. Wound infection following parotidectomy usually also ranges around 3.8% (Upton et al.) to 5.4% (Henney et al).
Hypothesis: 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.
Justification for study:
Review of the literature has shown paucity of publication about this particular complication and post operative preventative management. The current postoperative management following parotidectomies is not evidence based, and is institution or surgeon dependent, ranging from primary closure without a drain, to placement of a drain that is removed either on post-operative day 1-14 (in hospital or in the community), and from no overnight stay to patient hospitalization until the drain is removed. Patel et al. 2006 have published a review of postoperative drainage following their parotidectomies, including primary closure without drain, with drain, with absorbable hemostatic agents and with fibrin sealants. As mentioned by these authors, suction drains do not prevent hematomas, but do help to remove drainage and close dead space. In his paper, the average drain output on post operative day 1 was 27.1 ml, but these authors do not address the optimal time for drain removal. The timing of removal of neck drains following head and neck surgery was addressed by Harris T. et al, who found that drains could be safely removed when the volume falls to 50 ml or less over a 24 hour period, with only 9% of their patients developing seromas. Moreover, a retrospective review of the timing of neck hematoma formation post carotid endarterectomy showed that 95% of their patients experiencing neck hematomas or neurological deficits occurred within 8 hours following surgery, indicating that same evening discharge was possible following this type of surgery (Sheehan M.K et al).
In their prospective four armed randomized controlled trial investigating the use of subcutaneous catheter drain and antibiotic irrigation of abdominal incision closures, Farnell et al. have found no statistical difference in infection rate in wounds with lesser degree of contamination (Type II and III) between groups without drains and with drains for 4 days. Clean procedures (Type I wound) such as in parotidectomies should thus have similar infection rates with very temporary drains compared to no drains. The optimal time for catheter removal was however not addressed in this study.
The primary investigator has noted during his 30 years of practice as a Head and Neck surgeon that significant hematoma formation or bleeding that would require surgical management following parotidectomy is usually a very early complication that is often recognized within the few hours following surgery due to the superficiality of the wound, when the patient is in the postoperative area. It is our belief that removal of the drain in the post operative area, just prior to the patient's discharge allows for the decreased risk for unrecognized bleeding while and decreasing risks of nosocomial infections and patient colonization with resistant bacterial strains, unnecessary prolonged discomfort to the patient in the form of the drain, as well as unnecessary use of hospital resources such as the need for overnight stay in the hospital. The average cost for one postsurgical hospital day for an out of province resident at Vancouver General Hospital costs about C$3000 per day. We also believe that wound infection rate would be equivalent if not less.
Clinical equipoise exists as there is still controversy about the timing of the drain removal. Since no previous study has addressed the need or optimal timing of surgical drain removal following parotidectomies, we would also like to undertake a randomized controlled trial to address the hematoma and infection rate in post parotidectomy patients, depending on whether a drain is removed in the recovery area, or the next post operative day. This would follow a retrospective review study (H11-01433).
In our prospective randomized controlled trial, we would like to assess the rate of 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.
Provisions during the consenting process:
No provision is possible during the consenting process as the consent will be discussed with the patient on the phone.
Sample size & Statistical Analysis:
400 patients will be recruited to achieve a power of 0.8, taking into account that an intention to treat analysis will be undertaken, where it is assumed that average rate of hematoma formation post parotidectomy in the late drain removal group is 10% and 2.5% in early drain removal group.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
|Study Arms||Flat Davol drain
both arms will have flat davol drains placed at the end of the parotidectomy surgery
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||July 2013|
|Estimated Primary Completion Date||June 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT01399021|
|Other Study ID Numbers ICMJE||H11-01434|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Dr. Donald W. Anderson, University of Brtish Columbia - Vancouver Coastal Health Research Institute|
|Study Sponsor ICMJE||University of British Columbia|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of British Columbia|
|Verification Date||July 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP