Professional Documents
Culture Documents
Otolaryngology
Head and Neck Surgery
2015, Vol. 153(1) 3440
American Academy of
OtolaryngologyHead and Neck
Surgery Foundation 2015
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DOI: 10.1177/0194599815582156
http://otojournal.org
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Keywords
complication registration, quality assurance, postoperative
complications, tonsillectomy, tonsillotomy
Abstract
Objective. To find a suitable method to prospectively register
all tonsil surgeryrelated complications.
Ruohoalho et al
35
Results
During the 6-month study period, 794 patients underwent
tonsillectomy or tonsillotomy at the Department of ORLHNS, HUH. Of those excluded, 8 had tonsillectomy performed as part of the workup or treatment of head and
neck malignancy, 4 received simultaneous palatal surgery, 2 received retonsillectomy, and 64 underwent an
acute tonsillectomy. The remaining 143 did not give their
consent to participate. The final study group consisted of
573 patients (Figure 1), of whom 315 (55.0%) were
women. The median age was 19 years (range, 2-70). Four
hundred fifty-four (79.2%) patients underwent tonsillectomy, and 119 (20.8%) had tonsillotomy performed.
Patient characteristic and perioperative factors are presented in Table 2.
A total of 85 complications were registered in 79
patients. In the prospective data recording, we captured
64.7% of complications (69.6% of the patients with complications), and the rest were found in the revision of patient
charts. The most common complications were recorded
most comprehensively in prospective data collection; for
example, the prospectively registered proportion of minor
postoperative hemorrhages was 85.4% (Table 3).
The overall complication rate was 13.8%. Seventeen
patients (3.0%) had a major complication that necessitated
hospital admission. There was no mortality in the present
patient series. No medical complications were registered in
the database or noted when reviewing the patient records.
The total number of patients with postoperative hemorrhage was 55 (9.6%); 13 patients had 2 separate bleeding
episodes. All of the bleedings were secondary: 48 (87.2%)
were minor and 7 (12.7%) were major. However, none of
the patients needed blood transfusion. The median time
interval between the operation and the first bleeding episode
was 7 days (range, 2-13).
36
Definition
30
30
30
30
30
30
d of the
d of the
d of the
d of the
d of the
d of the
Table 3 presents the incidence of complications and proportions of prospectively registered events. Other complications not specified in Table 3 included 2 soft palate
perforations, 2 globus sensations, 1 functional disorder of
the palate, 1 worsening of tinnitus, 1 sensation of tongue
stiffness, and 1 case of prolonged pharyngeal pain, which
was relieved after 7 months. One 5-year-old girl was admitted to the hospital due to urticaria and fever 2 days after
tonsillectomy and one 6-year-old boy due to unclear muscular fatigue on the first postoperative day.
Discussion
The objective of registering surgical complications is to
improve the quality and safety of surgery. Our intention was
to find a feasible method to prospectively register surgical
complications with a view to specific features of ORL surgery. In this pilot project, we took tonsillectomies and tonsillotomies under scrutiny, since they are among the most
commonly performed surgical procedures at our institution.
This was a prospective cohort study of 573 patients undergoing tonsil surgery at our department during a 6-month
study period. We evaluated the comprehensiveness of data
collection and occurrence of postoperative complications in
terms of finding appropriate registration mode for continuous clinical use. We recorded 64.7% of complications prospectively, and the remaining 35.3% were observed when
operation
operation
operation
operation
operation
operation
Ruohoalho et al
37
reporting system for adverse surgical events,4,7 also covering head and neck procedures. In the United States, the
National Surgical Quality Improvement Program (NSQIP)
collects data in a standardized manner on 30-day postoperative outcomes for a randomized sample of patients
undergoing surgical procedures.25 In 2008, 47 ORL-HNS
programs submitted data.8 In a recent publication analyzing NSQIP data, the most common postoperative complications after tonsillectomy were pneumonia, urinary tract
infection, and superficial site infections,26 reflecting the
inability of general surgical complication registries to
catch ORL site-specific complications.
Our aim was to create a registry covering special features
of ORL surgery as well as possible. We included a large
number of variables to be collected into our pilot registry,
but many of them appeared to be rather useless in this relatively young and healthy patient population. Factors
reported to have an impact on complication occurrence in
tonsil surgery seem to be conventional (eg, age, sex,
BMI),11-13 and relevant background information is directly
available in the patient information system used in our operating rooms. We did exploit existing patient data, but they
38
573
19 (2-70)
250 (43.6)
323 (56.4)
258 (45.0)
315 (55.0)
21.0 (12.1-41.6)
527
42
3
1
(92.0)
(7.3)
(0.5)
(0.2)
527
38
4
3
1
(92.0)
(6.6)
(0.7)
(0.5)
(0.2)
457 (79.8)
107 (18.7)
9 (1.6)
454 (79.2)
119 (20.8)
216
79
48
216
5
9
(37.7)
(13.8)
(6.4)
(37.7)
(0.9)
(1.6)
323
147
103
157
(56.4)
(25.7)
(18.0)
(27.4)
397 (69.3)
176 (30.7)
0:20 (0:06-1:03)
558 (97.4)
15 (2.6)
Secondary hemorrhage
Minor
Major
Infection minor
Infection major
Dehydration
Pain major
Taste disturbance
Other complication
Any complication
n
55
48
7
6
1
4
4
5
10
79
%
9.6
8.4
1.2
1.0
0.2
0.7
0.7
0.9
1.7
13.8
Prospectively
Registered Events
n
45
41
4
4
1
0
1
2
2
55
%
81.8
85.4
57.1
33.3
100.0
0
25.0
40.0
20.0
69.6
Ruohoalho et al
39
Conclusion
We have demonstrated the initial feasibility of a prospective
complication registry for otolaryngology procedures, and
the results can be applied accordingly. We also present 5
practical recommendations when initiating a functional
complication registry. Particular attention should be paid to
registration of both serious and rare events. Regular analysis
of the results is required in order to respond to possible
changes in the incidence or nature of complications.
Acknowledgment
Matti Westman, MD, took part in designing the work and acquisition of data.
Authors Note
This trial was registered at clinicaltrials.gov. NCT 02049372.
Author Contributions
Johanna Ruohoalho, acquisition, analysis and interpretation of
data, main responsibility for writing the manuscript; Antti A.
Makitie, designing the work, analysis and interpretation of data,
Disclosures
Competing interests: None.
Sponsorships: None.
Funding source: The Helsinki University Hospital Research Fund
(no role in study).
References
1. Adler A, Lieberman D, Aminalai A, et al. Data quality of the
German screening colonoscopy registry. Endoscopy. 2013;45:
813-818.
2. Lawson EH, Louie R, Zingmond DS, et al. A comparison of
clinical registry versus administrative claims data for reporting
of 30-day surgical complications. Ann Surg. 2012;256:973-981.
3. Rebasa P, Mora L, Luna A, Montmany S, Vallverdu H,
Navarro S. Continuous monitoring of adverse events: influence
on the quality of care and the incidence of errors in general
surgery. World J Surg. 2009;33:191-198.
4. Marang-van de Mheen PJ, Stadlander MC, Kievit J. Adverse
outcomes in surgical patients: implementation of a nationwide
reporting system. Qual Saf Health Care. 2006;15:320-324.
5. Hessen Soderman AC, Ericsson E, Hemlin C, et al. Reduced
risk of primary postoperative hemorrhage after tonsil surgery
in Sweden: results from the national tonsil surgery register in
sweden covering more than 10 years and 54,696 operations.
Laryngoscope. 2011;121:2322-2326.
6. Lowe D, van der Meulen J, Cromwell D, et al. Key messages
from the national prospective tonsillectomy audit. Laryngoscope.
2007;117:717-724.
7. Veen EJ, Janssen-Heijnen ML, Leenen LP, Roukema JA. The
registration of complications in surgery: a learning curve.
World J Surg. 2005;29:402-409.
8. Stachler RJ, Yaremchuk K, Ritz J. Preliminary NSQIP results:
a tool for quality improvement. Otolaryngol Head Neck Surg.
2010;143:26-30, 30.e1-3.
9. Rautiainen H, Rasilainen J. Episodes of care: procedures and interventions 2010. National Institute for Health and Welfare. http://
www.thl.fi/tilastoliite/tilastoraportit/2011/Tr41_11.pdf.
Accessed
February 4, 2015.
10. Liu JH, Anderson KE, Willging JP, et al. Posttonsillectomy
hemorrhage: what is it and what should be recorded? Arch
Otolaryngol Head Neck Surg. 2001;127:1271-1275.
11. Tomkinson A, Harrison W, Owens D, Harris S, McClure V,
Temple M. Risk factors for postoperative hemorrhage following tonsillectomy. Laryngoscope. 2011;121:279-288.
12. Tolska HK, Takala A, Pitkaniemi J, Jero J. Post-tonsillectomy
haemorrhage more common than previously describedan
institutional chart review. Acta Otolaryngol. 2013;133:181-186.
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