4 PATIENTS AND METHODS
4.3 Definitions (studies I–IV)
The comorbidity burden was defined based on the Charlson comorbidity index (CCI), while complications relied on the Clavien–Dindo classification (CD). CCI (Charlson, Pompei et al. 1987) was calculated for each patient based on the diagnosis listed in the electronic medical records. We calculated a median index for all studies (studies I–IV).We used the CD classification (Dindo, Demartines et al. 2004) to categorise postoperative complications (Table 8). This classification relies on complication grades (I, II, IIIa, IIIb, Iva, IVb and V), determined by the severity and the type of therapy needed to correct the complication. Major complications are classified as CD grade IIIa or higher. The CD classification standardises the estimation of surgical complications reported in various surgical studies.
Table 8. Clavien–Dindo classification of surgical complications (Dindo, Demartines et al. 2004).
Grade Definition
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions
Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications
blood transfusions and total parenteral nutrition are also included Grade III Requiring surgical, endoscopic or radiological intervention Grade IIIa Intervention not under general anesthesia
Grade IIIb Intervention under general anesthesia
Grade IV Life-threatening complication (including central nervous system complications)*
requiring IC/ICU management
Grade IVa Single-organ dysfunction (including dialysis) Grade IVb Multiorgan dysfunction
Grade V Death of a patient
Suffix ‘d’ If the patient suffers from a complication at the time of discharge the suffix ‘d’
(for ‘disability’) is added to the respective grade of the complication. His label indicates the need for follow-up to fully evaluate the complication.
*brain hemorrhage, ischemic stroke, subarrachnoidal bleeding, but excluding transient ischemic attacks. CNS, central nervous system; IC, intermediate care; ICU, intensive care unit.
4.4 Surgical procedure (study II)
The diaphragm provides a natural barrier to achieving wide surgical resection margins if a malignant tumour is located on the thoracoabdominal wall just above or below the diaphragm (Figure 21). After a radical en-bloc resection of the thoracoabdominal wall and diaphragm, reconstruction is necessary.
In reconstruction, it is important to consider maintaining a functional diaphragm dome (Figure 22). Diaphragm reconstruction with mesh was required if the diaphragm resection extended beyond 3 to 4 cm since without mesh reconstruction the diaphragm cannot be pulled back to its normal location without too much tension.
Typically combined, a defect reconstruction begins with suturing the chest or abdominal wall stabilation mesh to the chest wall cranially. If diaphragm reconstruction is necessary, the other mesh is sutured to the defect of the
wall stabilation mesh is sutured to the muscular layers of the abdominal wall.
Finally, the chest or abdominal wall soft-tissue defect are closed with a flap or directly.
Thoracoabdominal
PI D Pe
Abdominal cavity
A. Chest wall tumour b. Abdominal wall tumour
Pleural cavity
Figure 21. Thoracoabdominal wall tumour and resection technique.
R, rib; Pl, pleura; D, diaphragm; Pe, peritoneum; T, tumour.
(Reproduced with permission from the Journal of Plastic Surgery and Hand Surgery (Kuwahara, Salo et al. 2018).)
Tumour resection Reconstruction with two meshes Tumour
Figure 22. Thoracoabdominal wall resection and functional diaphragm dome reconstruction.
(Reproduced with permission from the Journal of Plastic Surgery and Hand Surgery (Kuwahara, Salo et al. 2018).)
4.5 Oncological treatments (study III)
Patients were treated with neoadjuvant or adjuvant therapy if the surgical resection was marginal or/and the histology of the sarcoma was aggressive. Radiotherapy doses (conventionally fractionated) ranged from 42–66/1.5–2GY. Chemotherapy consisted of a doxorubicin (50 mg/m2) and ifosfamide (5 g/m2) combination (q21).
Patients received four to six cycles. Granulocyte stimulating factor (G-CSF) was administered if the risk of infection was considered high or if a low white blood cell count caused a delay to treatment.
4.6 Health-related quality-of-life measurement instruments and forms (study IV)
4.6.1 The 15D questionnaire
Generic HRQoL was measured using 15D (Sintonen 2001), a comprehensive instrument that covers 15 dimensions: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental functioning, discomfort or symptoms, depression, distress, vitality, and sexual activities. Respondents rate each dimension on a scale from 1 (no problems) to 5 (severe problems). 15D produces both an HRQoL profile based on dimension-level values and a single index score representing overall HRQoL. Both are generated by incorporating the
and minimal clinically important difference of the 15D score at 0.90 and 0.015, respectively (Stavem 1999, Alanne, Roine et al. 2015). Furthermore, 15D compares favourably to other similar generic HRQoL instruments in their most important psychometric properties (Stavem 1999, Richardson, Iezzi et al. 2016, Sintonen 2001, Hawthorne, Richardson et al. 2001, Moock, Kohlmann 2008).
4.6.2 EORTC QLQ-C30 questionnaire
The EORTC Core Quality of Life questionnaire C30 (QLQ-C30) is a standardised and self-administered instrument designed for use in the estimation of HRQoL amongst oncological patients. QLQ–C30 incorporates nine multi-item scales including five functional scales, three symptom scales, a global health and quality-of-life scale and six single-item symptom measurements. This scale of items results in a score ranging from 0 to 100, where a higher score for the functional, global health and quality of life of respondents indicates better health.
In the symptom scales, a higher score indicates a greater number of symptoms (Aaronson, Ahmedzai et al. 1993). Single-symptom items are scored in the following manner: 0 refers to no symptoms, ≤33.33 indicates mild symptoms,
≤66.66 indicates moderate symptoms and ≤100 indicates severe symptoms. Multi-item symptoms are scored in the following manner: 0 indicates no symptoms, 0.01 to 66.65 indicates mild symptoms, 66.66 to 99.99 indicates moderate symptoms and 100 indicates severe symptoms.
4.6.3 Sociodemographic and clinical questionnaire
We also collected information on participants’ age and sex, weight, height, comorbidities, medication, smoking history and habits, family circumstances and occupational status.