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Available online at www.sciencedirect.com

British Journal of Oral and Maxillofacial Surgery xxx (2011) xxxxxx

Complications after free ap surgery: do we need a standardized classication of surgical complications?

Christos Perisanidis a, , Beata Herberger a , Nikolaos Papadogeorgakis b , Rudolf Seemann a , Christina Eder-Czembirek a , Dietmar Tamandl c , Georg Heinze d , Panayiotis A. Kyzas e , Anastasios Kanatas f , David Mitchell f , Klaus-Dietrich Wolff g , Rolf Ewers a
a

Department of Cranio-, Maxillofacial and Oral Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria Department of Oral and Maxillofacial Surgery, University of Athens, Greece c Department of Surgery, Medical University of Vienna, Austria d Center for Medical Statistics, Informatics and Intelligent Systems, Section for Clinical Biometrics, Medical University of Vienna, Austria e Department of Oral and Maxillofacial Surgery, North Manchester General Hospital, United Kingdom f Department of Oral and Maxillofacial Surgery, Mid-Yorkshire Hospitals, United Kingdom g Department of Oral and Maxillofacial Surgery, Technical University of Munich, Germany
b

Accepted 25 January 2011

Abstract Our main objective was to apply a standard classication to surgical complications after free ap surgery for reconstructions of the head and neck. We used the modied ClavienDindo classication in a cohort of 79 patients who were having reconstructions with jejunal free aps simultaneously with resections of oral and oropharyngeal cancer. The most common minor complication was the need for a blood transfusion, and the most common major complication of a respiratory nature. The medical complications, and those at the recipient site and the donor site were 53/79 (67%), 44/79 (56%), and 9/79 (11%), respectively. The ClavienDindo classication is suitable and can easily be used to evaluate postoperative complications after free tissue transfer. 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Keywords: Postoperative complications; Microsurgical reconstruction; Oral and oropharyngeal cancer; ClavienDindo classication system; Jejunum ap

Introduction The assessment of surgical quality is an essential tool in the improvement of patients care,1 and the most commonly used surrogate marker of quality in surgery is the incidence of postoperative complications. Reporting these requires precision, consistency, and reproducibility, factors that can be guaranteed only through standard systems of classication.2 Since free ap surgery has become the standard method of reconstruction of complex defects in the head and neck,3 the outcomes of these procedures have been investigated.
Corresponding author. Tel.: +43 1 40400 4252; fax: +43 1 40400 4253. E-mail address: christos.perisanidis@meduniwien.ac.at (C. Perisanidis).

Unfortunately because of a lack of agreement in the denition of complications and their severity, available reports are inconsistent.49 Reporting of non-standard outcomes undermines any useful evaluation or comparison of complications, and makes valid identication of risk factors for specic complications impossible. The main objective of this study was to use a standard classication to record and grade surgical complications after free ap surgery for reconstruction of the head and neck. We used the modied ClavienDindo classication of surgical complications, based on the treatment required to correct a complication, in a group of patients who were having reconstructions with jejunal free aps at the same time as resection of oral and oropharyngeal cancers.10 This particular grading scale was previously validated in a large group

0266-4356/$ see front matter 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

doi:10.1016/j.bjoms.2011.01.013

Please cite this article in press as: Perisanidis C, et al. Complications after free ap surgery: do we need a standardized classication of surgical complications? Br J Oral Maxillofac Surg (2011), doi:10.1016/j.bjoms.2011.01.013

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C. Perisanidis et al. / British Journal of Oral and Maxillofacial Surgery xxx (2011) xxxxxx Table 1 ClavienDindo classication of surgical complications. Grade I Denition Any deviation from the normal postoperative course that does not require pharmacological treatment or surgical, endoscopic, or radiological interventions. Therapeutic regimens permitted are: drugs such as antiemetics, antipyretics, analgesics, diuretics, and electrolyte solutions, and physiotherapy. This grade also includes wound infections opened at the bedside. Requires pharmacological treatment with drugs other than those permitted for grade I complications; blood transfusions and total parenteral nutrition are also included. Requires surgical, endoscopic, or radiological intervention. Intervention not under general anaesthesia. Intervention under general anaesthesia. Life-threatening complications (including those of the CNS)a that require management in the high dependency or intensive care unit. Single-organ dysfunction (including dialysis). Multiple organ failure. Death. If the patient has a complication at the time of discharge, the sufx d (for disability) is added to the respective grade of complication. This label indicates the need for follow-up to evaluate the complication fully.

of patients having general surgical procedures, and is widely accepted for the reporting of complications in many elds of surgery.11 We also identied the risk factors associated with postoperative complications. Finally, we attempted to assess the impact of postoperative complications on survival.

Patients and methods Patients studied The records of 160 consecutive patients with a rst diagnosis of oral and oropharyngeal squamous cell carcinoma who were treated by neoadjuvant chemoradiotherapy followed by locoregional resection at the Department of Craniomaxillofacial and Oral Surgery, Medical University of Vienna, between January 2001 and December 2008 were reviewed retrospectively. The group comprised patients with clinical TNM stage IIIV tumours,12 who were treated with curative intent. Of 160 subjects, 79 patients had synchronous free jejunal ap reconstruction and resection of the tumour and were eligible for our study. Treatment All patients referred to our department with oral and oropharyngeal cancer are offered treatment decided by a multidisciplinary team. We have used 5-uorouracil and mitomycin C in standard neoadjuvant chemoradiotherapy since 1990, as previously described.13,14 Resection of the tumour combined with reconstruction with a jejunal free ap was scheduled 46 weeks after completion of chemoradiotherapy. Radical resection and concurrent neck dissection were done according to pretreatment staging. The jejunal ap was harvested through an open laparotomy by the general surgical team at the same time as the tumour was resected by the maxillofacial surgeons. Because the jejunal ap has poor ischaemic tolerance it was revascularised within 3 h of harvest.15 Postoperatively patients were transferred to the ICU where they were given prophylactic anticoagulants and antibiotics. The ap was monitored by clinical observation of its colour, peristalsis, and production of mucus, and by Doppler ultrasonography, at regular intervals. Long term follow-up continued for 5 years or until the patients death. Collection of data Data from all patients were collected from the hospitals database. Coexisting medical conditions were assessed using the validated Charlson comorbidity index, which scores the patient according to a weighted index of 19 medical conditions.16 The results were assessed in two groups as absence of comorbidity (score = 0) compared with the presence of comorbidity (score 1).
II

III IIIa IIIb IV

IVa IVb V Sufx d

a Brain haemorrhage, ischaemic stroke, subarachnoid bleeding, but excluding transient ischaemic attacks. CNS, central nervous system.

Classication of complications A complication was dened as any deviation from the normal postoperative course that was not inherent in the procedure and did not comprise a failure to cure.17 We investigated complications that developed postoperatively until the patients were discharged from hospital. All postoperative complications were graded according to the modied ClavienDindo classication of complications that focuses on the treatment used to cure complications (Table 1).10,11 Postoperative mortality was dened as death within 30 days of operation, or during the hospital stay. All complications were collected together and further subdivided into 3 categories: medical, and those at the recipient site and the donor site. Medical complications were classied by the organ system affected. Those at the recipient site were related to resection of the tumour and microvascular reconstruction, and those at the donor site were related to the harvest of the jejunal ap. Although some patients had more than one complication, for further analysis we counted only the highest-graded complication in each category. For the analysis of severity of the complications we created 3 groups: no complications, minor (grades I ad II), and major (grades IIIa, IIIb, IVa, IVb, and V). Infection of the wound was dened according to the Centers for Disease Control and Prevention criteria,18 and wound dehiscence as spontaneous partial or complete disruption after primary closure. Prescription of antibiotics was con-

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C. Perisanidis et al. / British Journal of Oral and Maxillofacial Surgery xxx (2011) xxxxxx 3 Table 2 Characteristics of the 79 patients studied. Data are number (%) except where otherwise stated. Characteristic Age Median (years) Range Sex Male Female Clinical TNM stage Stage II Stage III Stage IV Site of primary tumour Retromolar area Floor of the mouth Tonsillar fossa Tongue Base of the tongue Buccal mucosa History of alcohol consumption Current Former or never History of smoking Current Former or never Charlsons index 0 1 Neck dissection Ipsilateral Bilateral Tracheostomy Intraoperative Postoperative Duration of operation Median (min) IQR Duration of stay in hospital Median (days) IQR Duration of stay in intensive care Median (days) IQR
a

sidered as treatment of a complication only when associated with conrmed microbiological infection. Re-exploration was dened as an intervention designed to treat vascular compromise or haematoma. Postoperative tracheostomy was considered in the classication system only if it was done to correct grade IIIb medical complications. Nasogastric tubes were used routinely. Swelling of the upper aerodigestive tract, swallowing, and feeding difculties were dened as consequences of the disease, or its treatment, or both. Statistical analysis For univariate analysis Kendalls correlation coefcient taub was computed to correlate risk factors with the severity of postoperative complications. Multivariate ordinal logistic regression, using the severity of complications as the dependent variable and including risk factors found signicant by univariate analysis, was used to identify independent predictors of complications. The KaplanMeier method was used to analyse overall survival, and the univariate Cox regression analysis to evaluate the impact of postoperative complications on survival. Grade V complications were excluded from survival analysis. Probabilities of less than 0.05 were accepted as signicant. Statistical analysis was aided by the Statistical Package for the Social Sciences (version 17.0.1, SPSS Inc., Chicago, USA).

No. 58 2579 59 (75) 20 (25) 8 (10) 2 (3) 69 (87) 27 (34) 20 (25) 15 (19) 11 (14) 4 (5) 2 (3) 39 (49) 40 (51) 66 (84) 13 (17) 42 (53) 37 (47) 58 (73) 21 (27) 15 (19) 21 (27)a 595 520670 31 2145 7 615

Results Characteristics of the patients are summarised in Table 2. Each complication extracted from the hospitals database was converted into a complication grade (Table 3). A total of 159 complications developed in 67 of the 79 patients, resulting in a total complication rate of 85%. Of the 79 patients, minor complications developed in 16 (20%) and major complications in 51 (65%). Medical complications Medical complications developed in 53 of the 79 patients (67%). Of these, minor complications were recorded in 24 patients (30%) and major in 29 (37%) (Table 4). The most common major complication was respiratory insufciency, and the most common minor one the need for a blood transfusion. Three patients died during their hospital stay from multiple organ failure, two associated with sepsis. Postoperative tracheostomy was required in 15 patients to treat respiratory complications. Complications at the recipient site Complications developed at the recipient site in 44 of the 79 patients (56%). Of these minor complications developed in 9 patients (11%) and major in 35 (44%) (Table 4). The

6 patients needed tracheostomy because of swelling of the upper aerodigestive tract.

most common minor complications at the recipient site were infection and dehiscence of the wound, with dehiscence also being the most common major complication. The survival rate of jejunal free aps was 72/79 (91%). There were 17 re-explorations (in 12 cases for vascuTable 3 Postoperative complications classied by severity. Category Total no. Grade I Medical Recipient site Donor site Total 53 44 9 67 6 4 2 6 II 18 5 1 10 IIIa 10 6 3 12 IIIb 12 29 3 32 IVa 1 IVb 3 V 3

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Table 4 Distribution of postoperative complications. Postoperative complications Total no. Grade I Medical Total Respiratory Need for transfusion Neurological Multiple organ failure Cardiovascular Gastrointestinal Renal At recipient site Total Wound dehiscence Vascular compromise Haematoma Wound infection Fistula At donor site Total Burst abdomen Wound infection Abdominal bleeding 95 34 31 11 6 6 4 3 55 24 12 8 7 4 9 4 3 2 16 6 5 3 2 4 3 1 2 2 II 51 6 31 6 3 2 3 6 1 2 3 1 1 IIIa 7 7 6 5 1 3 2 1 IIIb 14 14 39 15 12 5 3 4 3 2 1 IVa 1 1 IVb 3 3 V 3 3

lar compromise (15%) and in a further 5 cases because of haematoma (6%)), resulting in a re-exploration rate of 22%. Re-exploration to evacuate a haematoma was successful in all 5 cases. Of the 12 compromised aps, 2 were completely salvaged (17%), 3 were partly salvaged (25%), and 7 were lost (58%). The causes of vascular compromise were venous thrombosis (n = 7), arterial infarct (n = 2), synchronous venous and arterial thrombosis (n = 2), and arterial kinking (n = 1). The causes of the lost aps were venous thrombosis (n = 3), arterial thrombosis (n = 2), and synchronous venous and arterial thromboses (n = 2). Analysis of risk factors showed that Charlsons comorbitity index was signicantly associated with re-exploration (p < 0.001), vascular compromise (p < 0.001), and complete loss of a ap (p = 0.003). Complications at the donor site Complications at the donor site developed in 9/79 patients (11%). Of the 9, minor complications developed in 3 (4%) and major in 6 (8%) (Table 4). The most common minor complication was infection of the wound and the most common major one dehiscence of the abdominal wall. Risk factors related to postoperative complications Univariate analysis showed that the site of the tumour (p < 0.001), alcohol consumption (p = 0,007), neck dissection (p = 0.02), and duration of operation (p = 0.003) were significantly associated with the development of complications. A

multivariate analysis failed to identify independent predictors of complications (Table 5). We analysed risk factors for medical complications and those at the recipient and donor sites using univariate models, and showed that only the duration of operation (p = 0.006) correlated signicantly with the development of medical complications. Duration of operation (p = 0.01) and type of neck dissection (p = 0.03) were signicantly associated with respiratory complications. Impact of postoperative complications on outcome The median duration of hospital stay of patients without complications was 19 days (IQR 1330) and with complications 34 days (2248). There was a highly signicant correlation between the severity of complications and the duration of stay in hospital and in the ICU (p < 0.001, Kendalls tau-b = +0.426, and p < 0.001, Kendalls tau-b = +0.474, respectively). There were also signicant correlations between medical complications and the duration of stay in hospital and the ICU (p = 0.004 and p < 0.001, respectively), and between complications at the recipient site and the duration of stay in hospital and the ICU (p < 0.001 and p = 0.003, respectively). There was no correlation between complications at the donor site and the duration of stay in hospital or the ICU (p = 0.95 and p = 0.52, respectively). Median follow-up was 55 months (IQR 3789) and median survival 52 months (IQR 1496). There was no signicant impact of total, medical, recipient site, or donor site complications on survival (p = 0.85, p = 0.13, p = 0.114, and p = 0.46, respectively; Table 6).

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Table 5 Correlation between risk factors and postoperative complications. Data are expressed as number, unless otherwise stated. Risk factors Total complications No Age: median (years) Sex Male Female Clinical TNM stage IIIII IV Site of tumour Oral cavity Oropharynx History of alcohol consumption Current Former or never History of smoking Current Former or never Charlsons index 0 1 Neck dissection Ipsilateral Bilateral Median duration of operation (min)
#

Kendalls tau-b Major 58 39 12 5 46 34 17 31 20 43 8 25 26 33 18 635 0.039 0.023 +0.105 +0.293 +0.279 +0.023 +0.100 +0.236 +0.250

P value

Multivariate# P value

Minor 58.5 10 6 3 13 14 2 4 12 13 3 10 6 15 1 572.50

60 10 2 2 10 12 0 4 8 10 2 7 5 10 2 532.50

0.681 0.827 0.335 <0.001 0.007 0.833 0.350 0.015 0.003

0.051 0.149 0.131 0.135

Multivariate ordinal logistic regression.

Discussion We adopted the ClavienDindo classication system to record and grade postoperative complications in a group of patients having reconstruction with a jejunal free ap at the same time as their oral and oropharyngeal cancer was resected. To our knowledge this is the rst study in which a standard classication was used to describe and rank postoperative complications after free tissue transfer for reconstruction of the head and neck.Until now there have been no established recommendations for reporting morbidity and mortality after such microvascular reconstructions. Published studies have shown considerable heterogeneity and extreme inconsistency as a result of subjective interpretation and non-standard reporting of complications. Some studies have presented invalid reporting of complications that has stemmed from serious shortcomings such as the absence
Table 6 Impact of postoperative complications on measures of outcome. Measures of outcome Total complication No Median duration of hospital stay (days) Median stay in intensive care (days) Median overall survival (months)
#

P value Major 35 12 54 <0.001* <0.001* 0.845#

Minor 21.5 6.5 55

19 4 52

Kendalls tau-b test. Cox regression; analysis excluded patients with grade V complications.

or lack of consensus about denitions of complications; the absence of, or varying denitions of, the postoperative period investigated; or the lack of accurate grading of complications.49 We have tried to minimise reporting errors and subjective interpretation of data about complications by dening both them and the period of morbidity investigated, and by using a standard grading system to rank them. The proposed morbidity scale provided an efcient and accurate format for assessing their incidence and severity. We found an overall complication rate of 85%, 65% of which were major. These high rates reect the exact nature of the ranking system, and show that it minimises any tendency to down-grade complications. Despite the high rates, mortality was low at 3.8%, in close agreement with previous studies.4,19 Postoperative pulmonary complications developed in 43% of patients and were the most common. Respiratory failure was found in about 9% of patients, in accordance with the ndings of Johnson et al.20 Of our patients, 39% were given postoperative blood transfusions, a decision taken on the basis of each individual patients condition. In publications about complications after free ap operations, blood transfusions are generally not assessed, which partly explains the differences between the high complication rates in our study and the lower ones in other studies.68 The most common complication at the recipient site was wound dehiscence, which developed in about 30% of patients. The success rate of reconstruction was 91%. Because of the low ischaemic tolerance of the jejunal

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C. Perisanidis et al. / British Journal of Oral and Maxillofacial Surgery xxx (2011) xxxxxx 7. Suh JD, Sercarz JA, Abemayor E, et al. Analysis of outcome and complications in 400 cases of microvascular head and neck reconstruction. Arch Otolaryngol Head Neck Surg 2004;130:9626. 8. Zafereo ME, Weber RS, Lewin JS, Roberts DB, Hanasono MM. Complications and functional outcomes following complex oropharyngeal reconstruction. Head Neck 2010;32:100311. 9. Jones NF, Jarrahy R, Song JI, Kaufman MR, Markowitz B. Postoperative medical complicationsnot microsurgical complicationsnegatively inuence the morbidity, mortality, and true costs after microsurgical reconstruction for head and neck cancer. Plast Reconstr Surg 2007;119:205360. 10. Dindo D, Demartines N, Clavien PA. Classication of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:20513. 11. Clavien PA, Barkun J, de Oliveira ML, et al. The ClavienDindo classication of surgical complications: ve-year experience. Ann Surg 2009;250:18796. 12. Licitra L, Grandi C, Guzzo M, et al. Primary chemotherapy in resectable oral cavity squamous cell cancer: a randomized controlled trial. J Clin Oncol 2003;21:32733. 13. Klug C, Berzaczy D, Voracek M, et al. Experience with microvascular free aps in preoperatively irradiated tissue of the oral cavity and oropharynx in 303 patients. Oral Oncol 2005;41:73846. 14. Klug C, Berzaczy D, Voracek M, Millesi W. Preoperative chemoradiotherapy in the management of oral cancer: a review. J Craniomaxillofac Surg 2008;36:7588. 15. Hikida S, Takeuchi M, Hata H, et al. Free jejunal graft autotransplantation should be revascularized within 3 hours. Transplant Proc 1998;30:34468. 16. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987;40:37383. 17. Dindo D, Clavien PA. What is a surgical complication? World J Surg 2008;32:93941. 18. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control 1999;27: 97132. 19. Haughey BH, Wilson E, Kluwe L, et al. Free ap reconstruction of the head and neck: analysis of 241 cases. Otolaryngol Head Neck Surg 2001;125:107. 20. Johnson RG, Arozullah AM, Neumayer L, Henderson WG, Hosokawa P, Khuri SF. Multivariable predictors of postoperative respiratory failure after general and vascular surgery: results from the patient safety in surgery study. J Am Coll Surg 2007;204:118898. 21. Feng GM, Yang WG, Huan-Tang Chen S, et al. Periodic alterations of jejunal mucosa morphology following free microvascular transfer for pharyngoesophageal reconstruction. J Plast Reconstr Aesthet Surg 2006;59:13127. 22. Wolff KD, Holzle F, Wysluch A, Mucke T, Kesting M. Incidence and time of intraoperative vascular complications in head and neck microsurgery. Microsurgery 2008;28:1436. 23. Girod A, Brancati A, Mosseri V, Kriegel I, Jouffroy T, Rodriguez J. Study of the length of hospital stay for free ap reconstruction of oral and pharyngeal cancer in the context of the new French casemix-based funding. Oral Oncol 2010;46:1904. 24. de Melo GM, Ribeiro KC, Kowalski LP, Deheinzelin D. Risk factors for postoperative complications in oral cancer and their prognostic implications. Arch Otolaryngol Head Neck Surg 2001;127: 82833. 25. de Cassia Braga Ribeiro K, Kowalski LP, Latorre Mdo R. Perioperative complications, comorbidities, and survival in oral or oropharyngeal cancer. Arch Otolaryngol Head Neck Surg 2003;129: 21928.

ap,15,21 strategies for shortening the ischaemic time of the ap, such as establishing reperfusion as the rst step in reconstruction,22 should be considered. This study also showed that patients comorbidities, as expressed by Charlsons comorbidity index, may have an impact on vascular compromise and can result in complete loss of a ap. The incidence of postoperative complications at the donor site was low at 11%, which led us to the conclusion that the abdominal surgery necessary for the harvest of a jejunal ap is safe. We accept that in this study we used only the jejunal ap, and that many other centres and studies use aps that do not require laparotomy. We showed that site of the tumour, alcohol consumption, type of neck dissection, and duration of operation were associated with the development of complications. The duration of stay in hospital and ICU were signicantly associated with medical complications and those at the recipient site, but not with those at the donor site. Duration of hospital stay has been used in several studies as a surrogate for severity of complications.8,9,23 However, duration of stay in hospital is strongly inuenced by the medical policy of each individual department, and therefore cannot be considered a reliable criterion for comparing outcomes either nationally or internationally. Although some authors24,25 have reported that postoperative complications after oral and oropharyngeal cancer surgery have a deleterious impact on long-term outcome, we have shown that postoperative complications cannot be declared to be independent predictors of survival. In conclusion, the ClavienDindo classication can easily be used to evaluate postoperative complications after free ap surgery. The use of this standard index will guide decisions on stratication of treatment, and ensure more consistency and a better quality of reporting in head and neck journals. We recommend the stratication of postoperative complications according to a standard classication.

References
1. Chassin MR, Loeb JM, Schmaltz SP, Wachter RM. Accountability measuresusing measurement to promote quality improvement. N Engl J Med 2010;363:6838. 2. Martin II RC, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg 2002;235:80313. 3. Nakatsuka T, Harii K, Asato H, Takushima A, Ebihara S, Kimata Y, et al. Analytic review of 2372 free ap transfers for head and neck reconstruction following cancer resection. J Reconstr Microsurg 2003;19:3638. 4. Eckardt A, Fokas K. Microsurgical reconstruction in the head and neck region: an 18-year experience with 500 consecutive cases. J Craniomaxillofac Surg 2003;31:197201. 5. Myers LL, Sumer BD, Defatta RJ, Minhajuddin A. Free tissue transfer reconstruction of the head and neck at a Veterans Affairs hospital. Head Neck 2008;30:100711. 6. Singh B, Cordeiro PG, Santamaria E, Shaha AR, Pster DG, Shah JP. Factors associated with complications in microvascular reconstruction of head and neck defects. Plast Reconstr Surg 1999;103:40311.

Please cite this article in press as: Perisanidis C, et al. Complications after free ap surgery: do we need a standardized classication of surgical complications? Br J Oral Maxillofac Surg (2011), doi:10.1016/j.bjoms.2011.01.013