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A retrospective comparison of the morbidity and cost of different reconstructive strategies in oral and oropharyngeal carcinoma

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Evaluate and compare the morbidity and costs of different reconstructive strategies in oral and oropharyngeal carcinoma. Retrospective cross-sectional. One hundred twenty-seven consecutive patients treated surgically for oral and oropharyngeal
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  The Laryngoscope Lippincott Williams zyxwvutsrqpo   Wilkins Inc. Philadelphia zyxwvutsr   zyxwvuts 999 The American Laryngological Rhinological and Otological Society Inc. zyxwvutsrq A Retrospective Comparison of the Morbidity and Cost of Different Reconstructive Strategies in Oral and Oropharyngeal Carcinoma Ludwig E. Smeele, MD, DMD, PhD; onathan C. Irish, MD, MSc, FRCSC; Patrick J Gullane, MB, FRCSC; Peter Neligan, MD, FRCSC; Dale H. Brown, MB, FRCSC; Lome E. Rotstein, MD, FRCSC zy Purpose: Evaluate and compare the morbidity and costs of different reconstructive strategies in zyxw ral and oropharyngeal carcinoma. zyxwv tudy Design: Retro- spective cross-sectional zyxwvuts atients and Methods One hundred twenty-seven consecutive patients treated surgically for oral and oropharyngeal carcinoma be- tween 1990 and 1996 were evaluated. Sixty-three pa- tients had segmental mandibulectomies with 30 plate- -soft tissue reconstructions and 33 bone-soft tissue flaps. Sixtyfour patients had soft-tissue-only recon- StrUCtiOnS. The following outcome parameters were analyzed: operative time, intraoperative blood loss, postoperative admission length, ICU and coronary care unit admission length, surgical interventions for complications, re-admissions, and prolonged (> mo) gastrostomy tube feeding, and all costs within the disease-free interval. Means and standard deviations were calculated for continuous parameters. Mer- ences among the three groups were analyd using one-way analysis of variance. For discontinuous pa- rameters, the chi-square test was applied. Results Longer operative time (1.8 h) and more blood loss (150 mL for bone-soft tissue flaps were the only statisti- cally significant findings p < 051 between the three groups. Concluswn There is no ationale for allowing presumed factors of morbidity or cost select for type of reconstruction in patients with oral and oropha- ryngeal carcinoma. Key Words: Squamous cell carci- noma, head and neck cancer, surgical flaps, microvas- cular surgery, morbidity analysis. Luryngoscope 109:800-804,1999 Presented at the Meeting of the American Society for Head and Neck Surgery Scottsdale Arizona May 12, 1997. From the Department of OtolaryngologyfHead and Neck Surgery (L.E.s., J.c.I., P.J.G., .H.B.), Division ofplastic Surgery (P.N.), and Division of General Surgery (L.E.R.), Head and Neck Program The Toronto Hospital Department of Surgical Oncology Princess Margaret Hospital University of Toronto Toronto Ontario Canada. Send Correspondence to Jonathan C. Irish MD, MSc, FRCSC 200 Elizabeth Street 7EN-228 Toronto ON M5G 2C4 Canada. INTRODUCTION Reconstruction of surgical defects with microsurgical free flaps after ablation for head and neck cancer is well established. Free flaps have been reported to produce low rates of wound healing complications and to produce sat- isfactory cosmetic and functional results.l.2 However, free flap reconstructions can cause morbidity at the donor site and often require more extensive surgery involving mul- tiple sites. For these reasons, some investigators have questioned whether the use of free flaps is acceptable in patients with a limited life expectancy such as the elderly or in patients with extensive disease.34 The effectiveness and efficacy of reconstruction of mandibular defects utilizing a plate with a soR tissue flap are established.6~7 owever, there appears to be no published study that utilizes morbid- ity and expense as outcome measures when comparing bone- containing flaps with SOR tissue flaps with or without seg- mental mandibular plate reconstruction. The purpose of the present study is to evaluate the morbidity and cost of surgical resection of squamous cell cancer and reconstruction with different types of free flaps. MATERIALS AND METHODS Patients Consecutive patients who underwent reconstruction with vascularized flaps from 1992 to 1996 with a diagnosis of primary or recurrent squamous cell carcinoma of the oral cavity and oropharynx were considered eligible for this study. One hundred twenty-seven patients were extracted from the head and neck surgery database at The Toronto Hospital. Sixty-three patients had segmental mandibulectomies, with 30 patients undergoing platesoft tissue reconstructions and 33 patients undergoing re- construction with bone-soft tissue flaps. Sixty-four patients had soft-tissue-only reconstructions Table I). Age and sex demo- graphics are presented in Table 11. The higher tumor stages were found, as may be expected, in the group with segmental resec- tions Tables I11 and zyxw v . iven the fact that in our center radio- therapy is the modality of choice for oropharyngeal lesions, the Laryngoscope 109: May 1999 800 Srneele et al.: Morbidity and Cost ofFree Flaps  TABLE I. Distribution zyxwvutsrqpo   Radial Forearm (RFF), Fibula (FIB), Iliac Crest (ILI), and Other Flaps in 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 Soft Tissue Only Flaps. zyxwvut FF FIB zyxwvutsrqpon LI Other Total Plate-soft tissue 26 zyxwvutsrqp   - 1 lateral thigh 30 1 lateral arm 2 rectus abdominus Bone-softtissue 5 24 3 1 RFF FIB 33 64 ofttissueonly 64 - - TABLE II. Distribution of Age and Sex (M/ in 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 Soft Tissue Only Flaps. MI F Mean Age (range) Q Plate-soft tissue 15 I15 64.8 (51-96) Bone-soft tissue 181 15 60.1 (32-85) Soft tissue only 461 18 53.3 (32-82) oral cavity was the predominant site of primary tumors (Tables zyxwvu   and VI). zyxwvutsrqpo utcome Variables Mortality was defined as a postoperative noncancer death within the first admission. Postoperative surgical and medical complications are listed in Tables VII and VIII. Rather than describing morbidity and mortality, we wanted to estimate the impact these factors have on the postoperative course in general and specifically on the disease-free interval. We defined the fol- lowing additional parameters: operative time, intraoperative blood loss, postoperative admission length, ICU and coronary care unit admission length, surgical interventions for complica- tions, re-admissions, and prolonged > 6 mo) gastrostomy tube feeding. zyxwvutsrq he concept of days of life lost was applied for the total amount of time each patient spent in the hospital, including the first admission and all reconstruction-related events within the disease-free interval. Initial admission costs were derived by adding the salaries of the operating room nursing staff, the cost of any utilized nonreusable supplies, the postanesthetic care unit (PACU) nurs- ing salaries, the surgical intensive care unit nursing salaries and supplies, and the ward nursing salaries and supplies. The oper- ating room nursing cost was calculated per patient based on an average hourly operating room nursing rate multiplied by the operating room case length in hours and multiplied by the num- ber of participating nurses per case. PACU nursing and surgical intensive care nursing costs were calculated similarly based on a nursing care ratio of one nurse to one patient. Ward nursing costs were calculated per patient based on an average nursing salary TABLE IV. Distribution of N-Stages in 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 Soft Tissue Only Flaps. NO N Recurrent Platesoft tissue 10 10 10 Bone-soft tissue 12 11 10 Soft tissue only 23 24 17 multiplied by the number of ward days per patient and divided by the average patient-to-nurse ratio on the ward. Nonreusable supplies used in the operating room (including plates) and ICU and during ward care were added at supply cost. Surgeons’ and anesthesiologists’ fees were calculated by billing each case according to the standardized Ontario Health Insurance Plan for all surgeons and anesthesiologists. Because hospitals are nonprofit institutions in Ontario and because all medical fees are standardized by the government and paid for by the government insurance plan, all costs quoted are the basic cost of care for the patient. Costs of complications or secondary costs were similarly calculated by adding operating room, ICU, coronary care unit, and specialists’ fees. Readmissions were only considered within the patient’s disease-free interval and only for reconstruction- related diagnoses. These costs were calculated similarly to initial costs. Statistics We assumed that the three types of reconstruction were independent variables. Means and standard deviations were cal- culated of continuous outcome parameters described above. Dif- ferences among the three groups were analyzed using the one- way analysis of variance. For discontinuous outcome parameters, the chi-square test was applied. RESULTS Morbidity Morbidity parameters are listed in Tables M and X. Among all variables tested, only the operative time for the primary intervention and for complications and the blood loss at the first operation were statistically significant TABLE V. Distribution of Radiotherapy Status in 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 Soft Tissue Only Flaps. Preoperative Postoperative None Plate-soft tissue 9 9 12 Bone-soft tissue 11 10 12 Soft tissue only 14 21 29 TABLE 111Distribution o T-Stages in 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 Soft Tissue Only Flaps. TABLE VI. Distribution of Tumor Sites in 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 Soft Tissue Only Flaps. T2 T3 T4 Recurrent Platesoft tissue 2 5 13 10 Bone-soft tissue 2 21 10 Soft tissue only 10 30 7 17 Oral Cavity Oropharynx Platesoft tissue 29 1 Bone-soft tissue 32 1 Soft tissue only 51 13 Laryngoscope 109: May 1999 Smeele et al.: Morbidity and Cost of Free Flaps 801  TABLE V11. Surgical Complications in zyxwvutsr 3 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 zyxwvutsr oft Tissue Only Flaps. zyxwv late-Soft Bone-Soft Soft Tissue Tissue Tissue Only 5 4 3 2 4 3 Complete flap loss Successful reanastomosis Neck hematoma Donor site hematoma Forearm fracture eck dehiscence with flap repair 2 TABLE VIII. Medical Complications in 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue Flaps, and 64 Soft Tissue Only Flaps. Plate-Soft Bone4oft Soft Tissue Tissue Tissue Only TABLE XAbsolute Numbers ofPatients With Morbidity Parameters (Discontinuous Variables) for 33 Bone-Soft Tissue Flaps, 30 Plate-Soft Tissue FlaDs. and zy 4 Soft Tissue Onlv Flaos. Plate-Soft Bone-Soft Soft Tissue zy   Value Tissue Tissue Only (chi-square) Secondary ICU/CCU 1 4 5 NS Secondary procedure 2 11 15 .036 Readmission 6 7 6 NS G-tube feeding 7 8 ,049 admission NS = not significant. should be noted that the relatively high cost of complica- tions in the soft-tissue-only flap group was mainly caused by one patient who was kept 110 days in the coronary care unit. 2 eart failure 2 Pneumonia 2 1 4 Atelectasis 1 Liver failure 1 Delirium 2 3 5 Myocardial infarction 1* 2   Postoperative death. differences. Bone-soft tissue flaps generated the longest operative time, followed by plate-soft tissue and soft- tissue-only flaps. The proportion of patients having a sec- ondary procedure zyxwvutsr r having prolonged gastrostomy tube feeding was also significantly higher for bone-soft tissue flaps. costs Costs were divided into three categories: the total sum within the first admission (initial), costs generated by complications within the first admission (secondary), and costs generated by readmissions (Fig. 1). There was a slight trend toward higher costs of bone-soft tissue flaps, but the differences were statistically not significant. It DISCUSSION It is important to note that this was not a prospective study and patients were not randomly selected to undergo one of the three types of reconstructions. Furthermore, it was assumed that the three types were independent vari- ables. his is not entirely true, as patients with a soft tissue defect would not need a reconstruction using a plate or vascularized bone for obvious reasons. Keeping this in mind, some significant issues can still be raised. There was one postoperative death in each of the three groups, accounting for a 3% mortality rate for each group, which is comparable to the mortality rates reported elsewhere.1 The mortalities were secondary to two myo- cardial infarctions and one liver failure in a patient with longstanding alcohol abuse. Some of the morbidity parameters defined were sig- nificantly worse for bone-soft tissue flaps. Harvesting vas- cularized bone and shaping an anatomically acceptable mandible may be expected to take more time and this was confirmed by longer operating room hours (1.8 h on aver- age) and more blood loss (150 mL on average) and there- fore may contribute to some increased postoperative mor- bidity in this patient group. TABLE IX. Morbidity Parameters (Continuous Variables) [Mean (Standard Deviation)] n 33 Bone-Soft Tissue Flaps, 30 Plat&oft Tissue Flaps, and 64 Soft Tissue Only Flaps. Plate-Soft BonAoft Soft Tissue P Value (one-way Tissue Tissue Only ANOVA) Primary OR time h) 12.4 (2.17) 14.2 (1.5) 11.9 (1.9) <.ooo 1 Blood loss mL) 1280 (928) 1430 (992) 1020 (581) ,043 Postop floor days 26.7 (23.1) 26.9 (17.9) 22.9 (20.8) NS Postop ICU days 0.3 (0.8) 0.3 (0.7) 0.3 (0.8) NS Secondary OR time h) 0.2 (0.7) 3.2 (7.4) 1.1 (2.8) .014 Secondary ICU/CCU days 0.7 (4.1) 0.7 2.2) 3.0 (1 6.3) NS Readmission floor days 1.7 (4.5) 3.0 (10.4) 0.9 (4.7) NSDays oflife lost 32.5 (25.6) 35.3 (27.5) 28.6 (25.0) NS NS = not significant; OR = operating room: ICU = intensive care unit; CCU = critical care unit. Laryngoscope 109: May 1999 802 Smeele et al.: Morbidity and Cost of Free Flaps  4 1 late-soft tissue z Fig. 1. Costs were divided into three categories: total sum within the first admission (initial), costs generated zyxwvuts y complications within the first admission (secondary), and costs generated by readmis- sions. Error bars indicate zyxwvuts 5 confidence intervals; ini zyxwvutsrqp   initial; com = complications; re-a = read- s a 0 . v zyxwvutsrqp   IT T zyxwv 0000 20000 10000 n missions; ali = total cost. ini There were five flap losses in the bone-soft tissue group. This accounted for a significantly higher proportion of patients undergoing a secondary procedure and with longer secondary operating room hours. It should be noted, however, that ischemic bone flaps were always replaced by other bone flaps, and after an earlier unsuc- cessful attempt at reanastomosis. In the soft-tissue-only group, there were three successful reanastomoses. The overall rate of total flap failure was 9 in 127 (7%). At 15%, the rate of loss was higher in the bone-soft tissue flap group 6/33: two iliac crests and three fibulas). The rate of free fibula flap loss was 12 (3/25). hese figures are slightly higher than those of Kroll et al.,S who reported a 10% ncidence of free fibula loss in mandibular reconstruc- tion, and Shpitzer et al.,g who reported an 8.5% failure rate. We recognize that our free fibula and iliac crest flap loss rate in this cohort of patients is slightly higher than expected. In fact, the Shpitzer study is from our center and reports our experience over a longer period of time. How- ever, even in this cohort of patients in which the free bone flap loss is high, the results suggest that economically the free flap bone and soft tissue strategy is at least equal to and perhaps better than the plate-soft tissue strategy of reconstruction. Donor site morbidity was not significantly different between the three groups. Indeed, the overall rate of donor site morbidity was low, with hematoma and partial skin graft loss being the most common occurrences. There was one forearm fracture in a patient who had a radial forearm osseocutaneous lap reconstruction. The donor site morbidity was similar to several other retrospective studies.l.ZJ0 Quality of life is, apart from survival, probably the most important outcome of any cancer treatment. The design of this study did not permit us to evaluate this issue. We could only calculate two indirect indicators: gastrostomy tube feeding and days of life lost. Patients with bone-soft tissue flaps had more longstanding gas- trostomy tube dependency than others. Days of life lost did not differ significantly among the groups. Boyd et al.7 compared days of life lost for osteocutaneous radial fore- arm flaps versus fasciocutaneous radial forearm flaps with reconstruction plates. The Boyd study was carried out in the same center as this present report, although in an earlier period (1987-1991). The authors describe fewer days of life lost for flaps containing vascularized bone versus those reconstructed with a plate and soft tissue reconstruction. This difference may be explained by the adoption of the THORP (titanium hollow osteointegrated -rT corn re-a all bone-soft tissue soft tissue reconstruction plate) plate system, which gives rise to fewer plate and screw failures. Another factor may be that in the present study mostly fibula flaps were used, and we experienced several flap failures in this group (Tables I and VII). Cost did not differ significantly among the three groups. his was to be expected, as neither did the mor- bidity parameters. Talesnik et 81.11 describe total costs for various types of free flap reconstructions starting at US$60,000. Kroll et al.8 calculated mean resource costs of US$28,460 for soft tissue free flaps. It is most likely that differences in the organization of the respective health care systems are responsible for these differences. CONCLUSION We recognize that retrospective comparison of a het- erogeneous clinical group should be taken with a degree of caution. However, it is likely that this comparison will never be possible in a randomized prospective trial. One significant argument in favor of plate-soft tissue recon- struction over bone-soft tissue reconstruction for patients undergoing segmental mandibular reconstruction has been the perceived decrease in operative time and pre- sumed lower cost per case. Based on this analysis, how- ever, although operative time and blood loss was higher in the free bone flap group, other outcome variables includ- ing admission length, ICU and coronary care unit admis- sion length, surgical interventions for complications, re- admissions, and prolonged gastrostomy tube feeding were no different among the groups. Furthermore, all costs within the disease-free interval were the same in the three groups. It is our opinion, therefore, that it is the patient factors such as disease stage, life expectancy, and quality of life that should be considered in the decision about the type of reconstruction after oral or oropharyngeal cancer ablation. BIBLIOGRAPHY 1. Urken ML, Weinberg H, Buchbinder D, et al. Microvascular free flaps in head and neck reconstruction. Report of 200 cases and review of complications. Arch Otolaryngol Head Neck Surg 1994;120:633-640. 2. Macnamara M, Pope S Sadler A, Grant H, Brough M. Micro- vascular free flaps in head and neck surgery. J Laryngol 3. Bridger AG, O Brien CJ, Lee KK. Advanced patient age should not preclude the use of free-flap reconstruction for head and neck cancer. Am Surg 1994;168:425-428. 4. Shestak KC, ones NF, Wu W, Johnson JT Myers EN. Effect OtOZ 1994;108:962-968. Laryngoscope 109: May 1999 Smeele et al.: Morbidity and Cost of Free Flaps 803  of advanced age and medical disease on the outcome of microvascular reconstruction for head and neck defects. zyxwvuts ead Neck zyxwvutsrqp 992;14:14-18. 5. Boyd JB, Morris S, Rosen IB, Gullane PJ, Rotstein LE, Free- man zyxwvutsr L. he through-and-through oromandibular defect: rationale for aggressive reconstruction. Plast Reconstr Surg 1994;93:44-53. 6 Blackwell KE, Buchbinder D, Urken ML. Lateral mandibular reconstruction using soft-tissue free flaps and plates. Arch Otolaryngol Head Neck Surg 1996;122:672-678. 7. Boyd JB, Mulholland RS, Davidson J, et al. The free flap and plate in oromandibular reconstruction: long-term re- view and indications. zyxwvutsrqp last Reconstr Surg 1995;95: 1018-1028. zyxwvutsrqp Laryngoscope zyxwvuts 09: zyxwvuts ay 1999 804 8. Kroll SS, Evans GRD, Goldberg D, et al. A comparison of resource costs for head and neck reconstruction with free and pectoralis major flaps. Plast Reconstr Surg 1997;99: 9. Shpitzer T, Neligan P, Gullane P, et al. Oromandibular re- construction with the fibular free flap. Arch Otolaryngol Head Neck Surg 1997;123:939-944. 10. Colen R, Shaw WW, McCarthy JG. Review of the morbidity of 300 free-flap donor sites. Plast Reconstr Surg 1986;77: 11. Talesnik A, Markowitz B, Calcaterra T, Ahn C, Shaw W. Cost and outcome of osteocutaneous free-tissue transfer versus pedicled soft-tissue reconstruction for composite mandibu- lar defects. Plast Reconstr Surg 1996;97:1167-1178. 1282-1287. 948-953. Smeele et al.: Morbidity and Cost of Free Flaps
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