A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention).

BACKGROUND: Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors' successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. METHODS: A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18-63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. RESULTS: Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study's reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81-1.03); no difference were found with regard to secondary effect measures. CONCLUSIONS: With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. TRIAL REGISTRATION: The study has been registered in the Dutch Trial Register ( NL6758/NTR7627 ).

Morbidity and extent of surgical resection of carcinoid tumors after endobronchial treatment.

OBJECTIVES: This study assessed whether endobronchial therapy (EBT) for bronchial carcinoid, if not curative, reduces the extent of the surgical resection and whether EBT is associated with increased surgical morbidity. MATERIAL AND METHODS: Analysis was performed in a cohort of patients with bronchial carcinoid who have undergone surgical resection. A group that underwent EBT before the surgery (S + EBT) was compared with a group where no EBT was performed (S-EBT). Postoperative complications were also compared between both groups. RESULTS: A total of 254 patients treated for a bronchial carcinoid tumor between 2003 and 2019 were screened for inclusion. A total of 65 surgically treated patients were included, of whom 41 (63%) underwent EBT prior to surgery. In 5 out of 41 patients (12%) from the S + EBT group, less parenchyma was resected versus 2 out of 24 (8%) from the S-EBT group (OR 1.528, 95% CI 0.273-8.562, p = 1.000). Two patients from the S + EBT group (5%) underwent lobectomy instead of sleeve lobectomy versus 0 from the S-EBT group (OR 1.051, 95% CI 0.981-1.127, p = 0.527). Comparing complications between the S + EBT and S-EBT group did not result in increased postoperative surgical morbidity (15% S + EBT, 24% S-EBT). CONCLUSION: EBT, if not curative, does not reduce the extent of the subsequent surgical resection. Therefore, if curative EBT is not anticipated, patients should directly be referred for surgery. If curative EBT seems feasible, it should be attempted not only because surgical resection can be prevented, but also because failure of EBT is not associated with excess surgical morbidity.

The Dilemma After an Unforeseen Positive Sentinel Node in Primary Breast Cancer: Is Completion Axillary Dissection Necessary?

BACKGROUND: In the majority of cases, the sentinel node is the only positive node in the axilla and completion ALND (cALND) is a futile procedure. However, refraining from cALND will lead to less accurate staging and, possibly, undertreatment. To help resolve this dilemma, we examined the clinical value of cALND in staging and determining adjuvant treatment. METHODS: In a retrospective cohort, all consecutive patients over a five-year period with primary breast cancer who received ALND were identified and grouped based on timing of ALND. Total nodal yield and positive lymph nodes were defined and factors with possible impact identified. In the case of cALND, N-status upstaging and possible impact on adjuvant treatment were studied in detail. RESULTS: A total of 280 patients were selected of whom 204 underwent primary ALND (pALND) and 76 cALND. pALND resulted in a significantly higher total nodal yield and more positive nodes when compared to cALND (p = 0.003, and p < 0.001, respectively). Neoadjuvant chemotherapy (NAC) had no effect on total nodal yield (p = 0.413), but resulted in fewer positive nodes (p < 0.001). Due to the results of cALND, only 11 patients (14%) had upstaging of N-status. All these patients were advised more extensive adjuvant radiotherapy. CONCLUSION: In the majority of patients, cALND does not lead to upstaging. cALND should be performed only after a careful discussion with the patient about the pros and cons of this procedure, and most probably only in the presence of multiple risk factors for axillary disease in the absence of systemic therapy.

Endobronchial and surgical treatment of pulmonary carcinoid tumors: A systematic literature review.

The treatment of pulmonary carcinoid has changed over the last decades. Although surgical resection is still the gold standard, minimally invasive endobronchial procedures have emerged as a parenchyma sparing alternative for tumors located in the central airways. This review was performed to identify the optimal treatment strategy for pulmonary carcinoid, with a particular focus on the feasibility and outcome of parenchyma sparing techniques versus surgical resection. A systematic review of the literature was carried out using MEDLINE, Embase and the Cochrane databases, based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement. Two separate searches of publications in endobronchial and surgical treatment in patients with pulmonary carcinoid, were performed. Outcomes were overall survival, disease free survival, recurrence rate, complications, quality of life, and healthcare costs. Combining the two main searches for endobronchial therapy and surgical therapy yielded 3111 records. Finally, 43 studies concerning surgical treatment and 9 studies related to endobronchial treatment for pulmonary carcinoid were included. Assessment of included studies showed that lymph node involvement, histological grade, tumor location and tumor diameter were identified as poor prognostic factors and seem to be important for patients with pulmonary carcinoid. For patients with a more favorable prognosis, tumor location and tumor diameter are important factors that can help decide on the optimal treatment strategy. Centrally located small intraluminal pulmonary carcinoids, without signs of metastasis can be treated with minimally invasive alternatives such as endobronchial treatment or parenchyma sparing surgical resection. Patients with parenchyma sparing resections should be followed with long term follow up to exclude recurrence of disease. In a multidisciplinary setting, it should be determined whether individual patients are eligible for parenchyma sparing procedures or anatomical resection. Overall evidence is of low quality and future studies should focus on prospective trials in the treatment of pulmonary carcinoid.

Two-Year Follow-Up of a Multi-centre Randomized Controlled Trial to Study Effectiveness of a Hospital-Based Work Support Intervention for Cancer Patients.

Purpose Purpose is to: (1) study effectiveness of the hospital-based work support intervention for cancer patients at two years of follow-up compared to usual care and (2) identify which early factors predict time to return-to-work (RTW). Methods In this multi-center randomised controlled trial (RCT), 106 (self-)employed cancer patients were randomized to an intervention group or control group and provided 2 years of follow-up data. The intervention group received patient education and work-related support at the hospital. Primary outcome was RTW (rate and time) and quality of life (SF-36), and secondary outcomes were, work ability (WAI), and work functioning (WLQ). Univariate Cox regression analyses were performed to study which early factors predict time to full RTW. Results Participants were diagnosed with breast (61%), gynaecological cancer (35%), or other type of cancer (4%). RTW rates were 84% and 90% for intervention versus control group. They were high compared to national register-based studies. No differences between groups were found on any of the outcomes. Receiving chemotherapy (HR = 2.43, 95% CI 1.59-3.73 p < 0.001), low level of education (HR = 1.65, 95% CI 1.076-2.52 p = 0.02) and low work ability (HR = 1.09 [95% CI 1.04-1.17] p = 0.02) were associated with longer time to full RTW. Conclusions We found high RTW rates compared to national register-based studies and we found no differences between groups. Future studies should therefore focus on reaching the group at risk, which consist of patients who receive chemotherapy, have a low level of education and have a low work ability at diagnosis. TRIAL REGISTRATION: Netherlands Trial Registry (NTR) (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1658): NTR1658.

Magnetic resonance imaging in patients with unilateral bloody nipple discharge; useful when conventional diagnostics are negative?

BACKGROUND: Unilateral bloody nipple discharge (UBND) is mostly caused by benign conditions such as papilloma or ductal ectasia. However, in 7-33 % of all nipple discharge, it is caused by breast cancer. Conventional diagnostic imaging like mammography (MMG) and ultrasonography (US) is performed to exclude malignancy. Preliminary investigations of breast magnetic resonance imaging (MRI) assume that it has additional value. With an increasing availability of MRI, it is of clinical importance to evaluate this. We evaluated the additional diagnostic value of MRI in patients with UBND in the absence of a palpable mass, with normal conventional imaging. METHODS: All women with UBND in the period November 2007-July 2012 were included. In addition to the standard work-up (patient's history, physical examination, MMG, and US), MRI was performed. Data from these examinations and treatment were collected retrospectively. RESULTS: A total of 111 women (mean age 52 years; range 23-80) were included. In nine (8 %) patients, malignancy was suspected on MRI while conventional imaging was normal. In eight (89 %) of these patients, histology was obtained, two by core biopsy and six by terminal duct excision. Benign conditions were found in six patients (86 %) and a (pre-) malignant lesion in two patients. In both cases, it concerned a ductal carcinoma in situ, which was treated with breast-conserving therapy. Moreover, in two cases of (pre)malignancy, the MRI was interpreted as negative. CONCLUSION: In patients with UBND who show no signs of a malignancy on conventional diagnostic examinations, the added value of a breast MRI is limited, since a malignancy can be demonstrated in <2 %.

Cardiac metastasis of malignant melanoma: a case report.

The heart is regularly involved in metastatic neoplasms with cardiac metastases being found in up to 20 % of autopsies. We present a case about a 42-year-old Caucasian female with a fatal metastatic melanoma to the heart. The five- year survival rate for stage IV melanoma (melanoma with metastases to other organs) is 15 to 20 %. If patients with malignant melanoma present with new onset of cardiac symptoms, clinicians should always be aware of the possibility of cardiac metastases and perform further investigations.

Comparison of extended hemicolectomy versus transverse colectomy in patients with cancer of the transverse colon.

BACKGROUND: Cancer of the transverse colon is rare and postoperative mortality tends to be high. Standard surgical treatment involves either extended hemicolectomy or transverse colectomy, depending on the location of the tumour. The aim of the present study was to compare postoperative mortality and five-year survival between these types of surgery. METHODS: For this observational study, data on patients with a tumour of the transverse colon, treated by open resection in the Dordrecht Hospital from 1989 through 2003, were derived from the database of the regional cancer registry. Information on type of resection, tumour stage, complications, postoperative mortality (30-day) and survival was abstracted from the medical files. Patients with multi-organ surgery, (sub)total colectomy or stage IV disease were excluded from the analysis, leaving a total series of 103 patients. RESULTS: Transverse colectomy comprised one third of operations, predominantly involving partial resections. Postoperative mortality was 6% (2/34) after transverse colectomy and 7% (5/69) after extended hemicolectomy. Five-year survival was slightly higher for the hemicolectomy group (61% versus 50%), but this difference did not reach statistical significance (p = 0.34). CONCLUSION: Our results confirm the high postoperative risk after surgery for cancer of the transverse colon and show that this risk does not depend on the type of surgery. Considering the satisfactory results after partial transverse colectomy, segmental resections may be considered as an option for the treatment of localised tumours of the transverse colon.

A hospital-based work support intervention to enhance the return to work of cancer patients: a process evaluation.

PURPOSE: To perform a process evaluation of a hospital-based work support intervention for cancer patients aimed at enhancing return to work and quality of life. The intervention involves the delivery of patient education and support at the hospital and involves the improvement of the communication between the treating physician and the occupational physician. In addition, the research team asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. METHODS: Eligible were cancer patients treated with curative intent and who have paid work. Data were collected from patients assigned to the intervention group (N = 65) and from nurses who delivered the patient education and support at the hospital (N = 4) by means of questionnaires, nurses' reports, and checklists. Data were quantitatively and qualitatively analysed. RESULTS: A total of 47 % of all eligible patients participated. Nurses delivered the patient education and support in 85 % of the cases according to the protocol. In 100 % of the cases at least one letter was sent to the occupational physician. In 10 % of the cases the meeting with the patient, the occupational physician and the supervisor took place. Patients found the intervention in general very useful and nurses found the intervention feasible to deliver. CONCLUSIONS: We found that a hospital- based work support intervention was easily accepted in usual psycho-oncological care but that it proved difficult to involve the occupational physician. Patients were highly satisfied and nurses found the intervention feasible.

Outcome of surgery for colovesical and colovaginal fistulas of diverticular origin in 40 patients.

INTRODUCTION: According to literature, colonic resection with a primary anastomosis and no defunctioning ileostomy is a safe treatment for colovesical or colovaginal fistula of diverticular origin. This study investigates the outcome of surgery for this patient group in a regional hospital. METHODS: Patients were obtained from a prospective database in the period 2004-2011. Several variables were investigated for their relation with surgical outcome. RESULTS: A colovesical (n = 35) or colovaginal (n = 5) fistula was diagnosed in 18 men and 22 women. The mean age was 69 years (range, 45-90). A rectosigmoid resection with primary anastomosis was performed in 32 patients. Fourteen patients received a defunctioning ileostomy. Eight patients were treated with a Hartmann procedure. Overall 30-day treatment-related morbidity and mortality was 48 and 8 %, respectively. Major morbidity, because of anastomotic leakage, was mainly observed in the primary anastomosis group without a defunctioning ileostomy. Morbidity and mortality were associated with high body mass index, diabetes, use of corticosteroids, and American Society of Anesthesiologists classification, though not significantly. CONCLUSIONS: One should be liberal in the use of a defunctioning ileostomy in case of a primary anastomosis after colonic resection for a diverticular fistula, in order to prevent high morbidity rates due to anastomotic leakage.

Comparison of 30-day, 90-day and in-hospital postoperative mortality for eight different cancer types.

BACKGROUND: Various definitions are used to calculate postoperative mortality. As variation hampers comparability between reports, a study was performed to evaluate the impact of using different definitions for several types of cancer surgery. METHODS: Population-based data for the period 1997-2008 were retrieved from the Rotterdam Cancer Registry for resectional surgery of oesophageal, gastric, colonic, rectal, breast, lung, renal and bladder cancer. Postoperative deaths were tabulated as 30-day, in-hospital or 90-day mortality. Postdischarge deaths were defined as those occurring after discharge from hospital but within 30 days. RESULTS: This study included 40,474 patients. Thirty-day mortality rates were highest after gastric (8·8 per cent) and colonic (6·0 per cent) surgery, and lowest after breast (0·2 per cent) and renal (2·0 per cent) procedures. For most tumour types, the difference between 30-day and in-hospital rates was less than 1 per cent. For bladder and oesophageal cancer, however, the in-hospital mortality rate was considerably higher at 5·1 per cent (+1·3 per cent) and 7·3 per cent (+2·8 per cent) respectively. For gastric, colonic and lung cancer, 1·0 per cent of patients died after discharge. For gastric, lung and bladder cancer, more than 3 per cent of patients died between discharge and 90 days. CONCLUSION: The 30-day definition is recommended as an international standard because it includes the great majority of surgery-related deaths and is not subject to discharge procedures. The 90-day definition, however, captures mortality from multiple causes; although this may be of less interest to surgeons, the data may be valuable when providing information to patients before surgery.

Hip fracture surgery and performance indicators: an analysis of 941 patients operated in a large teaching hospital.

BACKGROUND: In the Netherlands, two performance indicators for the treatment of hip fracture patients have been recently implemented. Both indicators state that surgery within 24 h after admission improves the outcome with regard to 1-year mortality and the amount of re-operations within 1 year. To determine the value of these performance indicators, we conducted a retrospective analysis of 941 hip fracture patients. METHODS: In the period from January 2003 to December 2006, a total of 941 consecutive hip fracture patients were included in this study. We determined the amount of re-operations and the mortality at 1 year after surgery. From June 2005 to December 2006, we could determine whether patients were operated on within 24 h after admission. In this group of 379 patients, we determined if there were differences in the 1-year mortality and the number of re-operations at 1 year with regard to the time window in which these patients were operated on (<24 h or >24 h). RESULTS: Our overall mortality rate at 1 year is 21% (202 patients) and the amount of re-operations within 1 year is 8% (77 procedures). In our subgroup analysis, we found no significant difference in mortality or re-operations if patients were operated on within 24 h or not (number needed to treat of 59 and -31, respectively). CONCLUSION: We conclude that hip fracture surgery within 24 h does not provide significantly better results in terms of 1-year mortality and the amount of re-operations within 1 year.

Preoperative MRI and surgical management in patients with nonpalpable breast cancer: the MONET - randomised controlled trial.

BACKGROUND: We evaluated whether performing contrast-enhanced breast MRI in addition to mammography and/or ultrasound in patients with nonpalpable suspicious breast lesions improves breast cancer management. METHODS: The MONET - study (MR mammography of nonpalpable breast tumours) is a randomised controlled trial in patients with a nonpalpable BIRADS 3-5 lesion. Patients were randomly assigned to receive routine medical care, including mammography, ultrasound and lesion sampling by large core needle biopsy or additional MRI preceding biopsy. Patients with cancer were referred for surgery. Primary end-point was the rate of additional surgical procedures (re-excisions and conversion to mastectomy) in patients with a nonpalpable breast cancer. FINDINGS: Four hundred and eighteen patients were randomised, 207 patients were allocated to MRI, and 211 patients to the control group. In the MRI group 74 patients had 83 malignant lesions, compared to 75 patients with 80 malignant lesions in the control group. The primary breast conserving surgery (BCS) rate was similar in both groups; 68% in the MRI group versus 66% in the control group. The number of re-excisions performed because of positive resection margins after primary BCS was increased in the MRI group; 18/53 (34%) patients in the MRI group versus 6/50 (12%) in the control group (p=0.008). The number of conversions to mastectomy did not differ significantly between groups. Overall, the rate of an additional surgical intervention (BCS and mastectomy combined) after initial breast conserving surgery was 24/53 (45%) in the MRI group versus 14/50 (28%) in the control group (p=0.069). INTERPRETATION: Addition of MRI to routine clinical care in patients with nonpalpable breast cancer was paradoxically associated with an increased re-excision rate. Breast MRI should not be used routinely for preoperative work-up of patients with nonpalpable breast cancer.

[Splenectomy in a large general hospital: often caused by iatrogenic injury, often causing multiple complications; poor adherence to post-operative guidelines for vaccination and prophylaxis]. / Splenectomie in een groot algemeen ziekenhuis: vaak iatrogeen letsel als oorzaak, veel complicaties tot gevolg; naleving postoperatieve richtlijnen voor vaccinatie en profylaxe gebrekkig.

OBJECTIVE: To assess the indications, complications and mortality associated with splenectomy in a large general hospital, and to evaluate adherence to guidelines for postoperative vaccination and prophylactic antibiotics. DESIGN: Retrospective, descriptive. METHOD: Data were collected on 106 patients who underwent splenectomy between 1999 and 2004. Indications for surgery, complications, duration of hospitalisation, and vaccination status were investigated retrospectively. Patients were contacted by telephone for a structured interview regarding vaccination and antibiotic prophylaxis. RESULTS: Of the 95 patients with sufficient data for analysis, 41 underwent elective surgery and 54 underwent non-elective surgery, including 37 who required splenectomy due to iatrogenic injury. Posteroperative complications arose in 45 patients, including 23 who developed serious complications. 10 patients died due to complications, including 7 who died within one month after the procedure. Vaccination coverage for the entire group was 58%. CONCLUSION: In this large general hospital, splenectomy was often performed due to iatrogenic injury and was associated with a relatively high complication rate. Adherence to guidelines on vaccination and prophylactic antibiotics could be improved.

Mesh fixation using staples in Lichtenstein's inguinal hernioplasty: fewer complications and fewer recurrences.

BACKGROUND: Fixation of the mesh in Lichtenstein's inguinal hernioplasty is traditionally performed with polypropylene sutures. A modification of this technique uses staples for securing of the mesh. METHOD: A retrospective comparative study of 149 elective repairs of a primary inguinal hernia was performed: a control group of 67 patients undergoing mesh fixation using sutures and a study group of 82 patients undergoing staple fixation. Operating time, recurrence, postoperative pain, complications and costs were studied. RESULTS: Seven recurrences (11%) occurred in the polypropylene group as compared to one recurrence (1%) in the staple group (P < 0.01). There was a trend of fewer complications in the staple group. Operative time and long-term postoperative pain did not differ significantly between the two groups. The costs per surgery for mesh fixation and skin closure were euro 11.13 for the suture group and euro 24.35 for the staple group. CONCLUSION: Staple fixation of the mesh in Lichtenstein's inguinal hernioplasty can be considered equal to traditional fixation with sutures with regard to operating time and postoperative pain. However, staple fixation seems to show fewer recurrences and fewer complications.

Urachus fistula: a rare first presentation of diverticulitis.

Urachus fistulas are rare, especially in adulthood. In grown-ups urachus fistulas are usually a reflection of Crohn's disease. We present a patient in whom an urachus fistula was the first presentation of diverticulitis of the sigmoid colon. The need for proper preoperative diagnostic imaging is discussed.

Prevention of futile sentinel node procedures in breast cancer: ultrasonography of the axilla and fine-needle aspiration cytology are obligatory.

AIMS: To determine the value of ultrasonography (US) and fine-needle aspiration (FNA) of the axilla in preventing futile sentinel node procedures (SNP) in breast cancer. METHODS: Between July 2004 and June 2005, 209 female patients were evaluated and treated in our clinic for histologically proven breast carcinoma. We analysed the results of axillary staging by US and FNA retrospectively. Furthermore, we correlated the histopathologic outcome of operative procedures with the preoperative findings during examination of the axilla. RESULTS: Of the 209 patients, 195 underwent US of the axilla. In 67 patients, US was followed by FNA because of suspect lymph nodes in the axilla. Ninety-three of these 195 patients had axillary metastases. In 52 of these 93 patients, the metastases were detected prior to surgery, so that these 52 patients could be scheduled immediately for axillary lymph node dissection (ALND) and a futile SNP could be prevented. US/FNA yielded false-negative results in 41 cases, 13 of which had only a micrometastasis. CONCLUSIONS: By preoperative US and FNA of the axilla in patients with breast cancer, half of the axillary metastases can be detected prior to surgery. In more than a quarter of breast cancer patients, a futile SNP can be prevented. Therefore, preoperative US of the axilla plus FNA are obligatory in patients with breast carcinoma.