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
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Rate of hematoma formation
研究概览
简要总结
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.
详细描述
Background:
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Rate of hematoma formation
时间窗: 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
次要结局
- Rate of infection(Within 30 days following surgery)
