Physiotherapy With Telerehabilitation in Patients With Complicated Postoperative Recovery After Esophageal Cancer Surgery: Feasibility Study.

BACKGROUND: Improvement of functional status with physiotherapy is an important goal for patients with postoperative complications and an increased length of hospital stay (LoS) after esophagectomy. Supervised physiotherapy with telerehabilitation instead of conventional face-to-face care could be an alternative to treat these patients in their home environment after hospital discharge (T0), but its feasibility has not yet been investigated in detail. OBJECTIVE: The aim of this study was to investigate the feasibility of a 12-week supervised postoperative physiotherapy intervention with telerehabilitation for patients with esophageal cancer who underwent esophagectomy and had postoperative complications or who had an increased LoS. The secondary objective was to investigate the preliminary effectiveness of telerehabilitation on functional recovery compared with usual care. METHODS: A prospective feasibility study with a matched historical comparison group was performed. Feasibility outcomes included willingness and adherence to participate, refusal rate, treatment duration, occurrence of adverse events, and patient satisfaction. Secondary outcome measures were measurements of musculoskeletal and cardiovascular functions and activities according to the domains of the International Classification of Functioning, Disability and Health. RESULTS: A total of 22 patients with esophageal cancer who underwent esophagectomy and had postoperative complications or an increased LoS were included. The mean age at surgery was 64.55 (SD 6.72) years, and 77% (17/22) of patients were male. Moreover, 15 patients completed the intervention. Patient adherence was 99.8% in the first 6 weeks and dropped to 75.6% in the following 6 weeks, with a mean difference of -24.3% (95% CI 1.3 to 47.2; P=.04). At 3 months post operation, no differences in functional status were found between the intervention group and the matched historical comparison group. CONCLUSIONS: This study showed that a postoperative physiotherapeutic intervention with telerehabilitation is feasible for patients with postoperative complications or an increased LoS after esophageal cancer surgery up to 6 weeks after T0.

Development of a tailored work-related support intervention for gastrointestinal cancer patients.

Aim is the development of a work-related support intervention, tailored to the severity of work-related problems of patients diagnosed with gastrointestinal (GI) cancer treated with curative intent. Two methods were used: (1) Work-related problems were identified from the literature and submitted to an expert panel during a modified Delphi study. Experts allocated work-related problems into degrees of severity: mild, severe or complex. In addition, experts indicated which health care professional should provide the tailored support: (2) These outcomes were combined with existing interventions to design the tailored intervention. Semi-structured interviews with experts were conducted to assess whether the intervention was comprehensive, and feasible for daily practice. A decision diagram measuring severity of work-related problems was developed based on the modified Delphi study with 44 experts, encompassing social, disease and occupational problems. Based on the degree of severity, support was provided by: an oncological nurse (mild), oncological occupational physician (severe) or multidisciplinary team (complex). The intervention encompassed three individual meetings in the clinical setting and was considered comprehensive and feasible by 12 experts. The intervention is innovative in combining oncological and occupational care in the clinic and being tailored to the needs of GI cancer patients with specific work-related problems.

Is there a Benefit of Multidisciplinary Cancer Team Meetings for Patients with Gastrointestinal Malignancies?

BACKGROUND: Multidisciplinary cancer team meetings are intended to optimize the diagnosis of a patient with a malignancy. The aim of this study was to assess the number of correct diagnoses formulated by the multidisciplinary team (MDT) and whether MDT decisions were implemented. METHODS: In a prospective study, data of consecutive patients discussed at gastrointestinal oncology MDT meetings were studied, and MDT diagnoses were validated with pathology or follow-up. Factors of influence on the correct diagnosis were identified by use of a Poisson regression model. Electronic patient records were used to assess whether MDT decisions were implemented, and reasons to deviate from these decisions were hand-searched within these records. RESULTS: In 74 MDT meetings, 551 patients were discussed a total of 691 times. The MDTs formulated a correct diagnosis for 515/551 patients (93.4 %), and for 120/551 (21.8 %) patients the MDT changed the referral diagnosis. Of the MDT diagnoses, 451/515 (87.6 %) were validated with pathology. Patients presented to the MDT by their treating physician were 20 % more likely to receive a correct diagnosis [relative risk (RR) 1.2, 95 % confidence interval (CI) 1.1-1.5], while the number of patients discussed or the duration of the meeting had no influence on this (RR 1.0, 95 % CI 0.99-1.0; RR 1.0, 95 % CI 0.9-1.1; resp.). MDT decisions were implemented in 94.4 % of cases. Deviations of MDT decisions occurred when a patient's wishes or physical condition were not taken into account. CONCLUSIONS: MDTs rectify 20 % of the referral diagnoses. The presence of the treating physician is the most important factor to ensure a correct diagnosis and adherence to the treatment plan.

Design of a multicentre randomized controlled trial to evaluate the effectiveness of a tailored clinical support intervention to enhance return to work for gastrointestinal cancer patients.

BACKGROUND: Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. METHODS/DESIGN: We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. DISCUSSION: The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and occupational care in a clinical setting, early in the cancer treatment process. TRIAL REGISTRATION: METC protocol number NL51444.018.14/Netherlands Trial Register number NTR5022 . Registered 6 March 2015.

Immunohistochemical analysis of steroid hormone receptors in hidradenitis suppurativa.

BACKGROUND: Hidradenitis suppurativa (HS) is an inflammatory follicular skin disease. In women and men, the condition starts after puberty, has a peak in the third decade, and is rare after the menopause in women. This age distribution suggests a hormonal influence in the pathogenesis of the disease. We therefore hypothesized that apocrine glands in HS patients have a different expression of androgen receptor (AR) and estrogen receptor (ER) compared with healthy skin. METHODS: Axillary, inguinal, and perianal skin biopsies from female and male patients with HS were immunohistochemically stained for AR and ER activities. Expression of both receptors in apocrine glands of HS patients was compared with expression in apocrine glands in normal axillary or inguinal skin of a control group of women. RESULTS: Twenty-two patients with HS were included (16 women), with 10 women in the control group. In the HS group, apocrine glands were present in 11 out of 22 skin biopsies and in the control group in 4 out of 10 biopsies. Expression of ER in the apocrine gland was weak and observed in 2 out of 4 patients in the control group and in none of the HS patients. Expression of the AR was strong and observed in all apocrine glands in both groups. CONCLUSIONS: We could not demonstrate a significant difference in the expression of ER and AR in apocrine glands in skin biopsies of patients with HS, compared with healthy skin biopsies. The exact relation between sex hormones and occurrence of HS therefore remains unclear.

Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.

BACKGROUND: If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects. METHODS: Patients with T1-2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised, multicentre, open-label, phase 3 non-inferiority EORTC 10981-22023 AMAROS trial. Patients were randomly assigned (1:1) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node, stratified by institution. The primary endpoint was non-inferiority of 5-year axillary recurrence, considered to be not more than 4% for the axillary radiotherapy group compared with an expected 2% in the axillary lymph node dissection group. Analyses were by intention to treat and per protocol. The AMAROS trial is registered with ClinicalTrials.gov, number NCT00014612. FINDINGS: Between Feb 19, 2001, and April 29, 2010, 4823 patients were enrolled at 34 centres from nine European countries, of whom 4806 were eligible for randomisation. 2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy. Of the 1425 patients with a positive sentinel node, 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy; these patients constituted the intention-to-treat population. Median follow-up was 6·1 years (IQR 4·1-8·0) for the patients with positive sentinel lymph nodes. In the axillary lymph node dissection group, 220 (33%) of 672 patients who underwent axillary lymph node dissection had additional positive nodes. Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group. 5-year axillary recurrence was 0·43% (95% CI 0·00-0·92) after axillary lymph node dissection versus 1·19% (0·31-2·08) after axillary radiotherapy. The planned non-inferiority test was underpowered because of the low number of events. The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0·00-5·27, with a non-inferiority margin of 2. Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year, 3 years, and 5 years. INTERPRETATION: Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1-2 primary breast cancer and no palpable lymphadenopathy. Axillary radiotherapy results in significantly less morbidity. FUNDING: EORTC Charitable Trust.

Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial.

BACKGROUND: Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern. We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesophagectomy. METHODS: We did a multicentre, open-label, randomised controlled trial at five study centres in three countries between June 1, 2009, and March 31, 2011. Patients aged 18-75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were randomly assigned via a computer-generated randomisation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy. Randomisation was stratified by centre. Patients, and investigators undertaking interventions, assessing outcomes, and analysing data, were not masked to group assignment. The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. FINDINGS: We randomly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group. 16 (29%) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five (9%) in the minimally invasive group (relative risk [RR] 0·30, 95% CI 0·12-0·76; p=0·005). 19 (34%) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven (12%) in the minimally invasive group (0·35, 0·16-0·78; p=0·005). For in-hospital mortality, one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage. INTERPRETATION: These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer. FUNDING: Digestive Surgery Foundation of the Unit of Digestive Surgery of the VU University Medical Centre.

Survival after recurrent esophageal carcinoma has not improved over the past 18 years.

BACKGROUND: Numerous patients will develop recurrent disease after esophagectomy for esophageal carcinoma (EC). In literature, survival after recurrent EC is poor with 6-8 months. In these studies, diagnostic imaging during follow-up (FU) is routinely performed. In the Netherlands, routine imaging is not part of FU and only performed on indication. The aim of this study was to determine survival after diagnosis of recurrent disease in patients after esophagectomy without routine imaging during FU. METHODS: All EC patients who underwent esophagectomy between 1993 and 2010 were included and followed for clinical evidence of recurrent EC. Location, symptoms, diagnosis, and treatment of recurrent disease were registered. Pattern of recurrence was compared between patients who underwent neoadjuvant therapy and patients who underwent surgery alone. Survival after detection of recurrence was determined in all patients and related to the year of surgery. RESULTS: A total of 493 of 1,088 patients (45 %) who underwent esophagectomy between 1993 and 2010 developed recurrent disease. Median interval between esophagectomy and recurrence was 10.5 months. Within the first 2 years after surgery, 33 % of patients developed recurrent EC. The majority of patients (51 %) were diagnosed with distant metastases. Locoregional recurrence occurred significantly less often among patients who underwent neoadjuvant therapy (6 vs 16 %, p = .017). Median survival after diagnosis of recurrent disease was 3 months. No relation was observed between the year of surgery and survival after recurrent disease (p = .931). CONCLUSIONS: Survival after recurrent EC in patients who undergo FU without routine imaging after esophagectomy is approximately 3 months and has not improved over the past 18 years.

Initial experiences of an enhanced recovery protocol in esophageal surgery.

BACKGROUND: A recent development in gastrointestinal surgery is the implementation of enhanced recovery after surgery (ERAS) programs. Evidence regarding the benefit of these programs in patients undergoing esophageal surgery is scarce. We investigated the feasibility and possible benefit of a perioperative ERAS program in patients undergoing esophagectomy for malignant disease. METHODS: The ERAS program was initiated in 2009. Patients who underwent esophagectomy and were treated according to the ERAS program were included. Items of ERAS included preoperative nutrition, early extubation, early removal of nasogastric tube, and early mobilization. Primary outcome parameters were hospital stay and the incidence of postoperative complications. Outcome parameters in the ERAS cohort were compared to a cohort of patients who underwent surgical resection in the year prior to the implementation of the ERAS protocol. A feasibility analysis was performed among a sample of ERAS patients to determine the number of achieved items per patient. RESULTS: Between 2008 and August 2010, 181 patients in our department underwent esophagectomy. Of these, 103 patients were included in the ERAS program (ERAS+ group) and were compared to 78 patients who had undergone an esophagectomy in 2008 (ERAS- group). Overall hospital stay was 14 days versus 15 days (ERAS+ and ERAS-, respectively; p = 0.013). There were no significant differences in the incidence of postoperative complications in either group. The percentage of achieved items varied between 42 and 93 % per item. CONCLUSIONS: The implementation of an ERAS program in esophageal surgery was feasible and resulted in a small but significant reduction in overall hospital stay, whereas overall morbidity was not affected.

Radiotherapy or Surgery of the Axilla After a Positive Sentinel Node in Breast Cancer: 10-Year Results of the Randomized Controlled EORTC 10981-22023 AMAROS Trial.

PURPOSE: The European Organisation for Research and Treatment of Cancer 10981-22023 AMAROS trial evaluated axillary lymph node dissection (ALND) versus axillary radiotherapy (ART) in patients with cT1-2, node-negative breast cancer and a positive sentinel node (SN) biopsy. At 5 years, both modalities showed excellent and comparable axillary control, with significantly less morbidity after ART. We now report the preplanned 10-year analysis of the axillary recurrence rate (ARR), overall survival (OS), and disease-free survival (DFS), and an updated 5-year analysis of morbidity and quality of life. METHODS: In this open-label multicenter phase III noninferiority trial, 4,806 patients underwent SN biopsy; 1,425 were node-positive and randomly assigned to either ALND (n = 744) or ART (n = 681). RESULTS: Per intention-to-treat analysis, 10-year ARR cumulative incidence was 0.93% (95% CI, 0.18 to 1.68; seven events) after ALND and 1.82% (95% CI, 0.74 to 2.94; 11 events) after ART (hazard ratio [HR], 1.71; 95% CI, 0.67 to 4.39). There were no differences in OS (HR, 1.17; 95% CI, 0.89 to 1.52) or DFS (HR, 1.19; 95% CI, 0.97 to 1.46). ALND was associated with a higher lymphedema rate in updated 5-year analyses (24.5% v 11.9%; P < .001). Quality-of-life scales did not differ by treatment through 5 years. Exploratory analysis showed a 10-year cumulative incidence of second primary cancers of 12.1% (95% CI, 9.6 to 14.9) after ART and 8.3% (95% CI, 6.3 to 10.7) after ALND. CONCLUSION: This 10-year analysis confirms a low ARR after both ART and ALND with no difference in OS, DFS, and locoregional control. Considering less arm morbidity, ART is preferred over ALND for patients with SN-positive cT1-2 breast cancer.

Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial.

BACKGROUND: The randomized EORTC 10981-22023 AMAROS trial investigates whether breast cancer patients with a tumor-positive sentinel node biopsy (SNB) are best treated with an axillary lymph node dissection (ALND) or axillary radiotherapy (ART). The aim of the current substudy was to evaluate the identification rate and the nodal involvement. METHODS: The first 2,000 patients participating in the AMAROS trial were evaluated. Associations between the identification rate and technical, patient-, and tumor-related factors were evaluated. The outcome of the SNB procedure and potential further nodal involvement was assessed. RESULTS: In 65 patients, the sentinel node could not be identified. As a result, the sentinel node identification rate was 97% (1,888 of 1,953). Variables affecting the success rate were age, pathological tumor size, histology, year of accrual, and method of detection. The SNB results of 65% of the patients (n = 1,220) were negative and the patients underwent no further axillary treatment. The SNB results were positive in 34% of the patients (n = 647), including macrometastases (n = 409, 63%), micrometastases (n = 161, 25%), and isolated tumor cells (n = 77, 12%). Further nodal involvement in patients with macrometastases, micrometastases, and isolated tumor cells undergoing an ALND was 41, 18, and 18%, respectively. CONCLUSIONS: With a 97% detection rate in this prospective international multicenter study, the SNB procedure is highly effective, especially when the combined method is used. Further nodal involvement in patients with micrometastases and isolated tumor cells in the sentinel node was similar-both were 18%.

[What do the results of the DENSE-trial tell?] / Wat zeggen de uitkomsten van de DENSE-studie?

The DENSE trial has demonstrated that offering an MRI scan to women with very dense glandular breast tissue and normal results on screening mammography reduces the number of interval cancers by 50%. In the women who agreed to undergo an MRI (59%), this reduction was 80% (from 5 per 1000 to 1 per 1000 participants). DENSE will continue in order to answer the only question that is relevant to patients: does additional MRI lead to less invasive treatment and, above all, to a decrease in mortality? Even in the event where additional MRI screening would lead to a decrease in mortality, we still need to have an open discussion on whether investing in additional MRI screening for women with very dense glandular tissue is the most effective way to improve the health of the Dutch female population. Thanks to the great effort of the DENSE research team, such a discussion can be pursued thoroughly, based on facts.

Is a tailored work-related support intervention feasible in everyday clinical practice? The experience of healthcare professionals and patients with cancer.

BACKGROUND: Work is valued as an important feature in life, however patients diagnosed with cancer can experience work-related problems. We developed a work-related support intervention to support those in need. OBJECTIVE: The objective of this study was to evaluate the feasibility of the performed tailored GIRONA (Gastro Intestinal cancer patients Receiving Occupational support Near and After diagnosis) intervention and to describe the experiences of those receiving the work-related support and of those providing it. METHODS: An online questionnaire was used to survey the feasibility of the intervention of the support recipients (patients diagnosed with gastrointestinal cancer) and the support providers (healthcare professionals including: oncology nurses and oncological occupational physicians). Five themes were covered: acceptability, demand, implementation, practicality and integration of Bowen's feasibility model. RESULTS: Twenty-three patients, 14 oncology nurses and 4 oncological occupational physicians, shared their experiences about the tailored work-related support intervention. This intervention was generally perceived as positive and feasible by the participants. Some patients received work-related support despite not experiencing severe problems; others mentioned that they received no such support even though they did need it. Despite positive experiences, there are some barriers to tackle, such as length of consultation, timing of the initiation of work-related support and embedding the oncological occupational physician within the clinical setting. CONCLUSION: According to the healthcare professionals involved, GIRONA is feasible, however some practical barriers were mentioned. The intervention was perceived as positive by both patients and healthcare professionals, but the tailored component could be further improved to better support those in need of work-related support.

The pre- and postoperative course of functional status in patients undergoing esophageal cancer surgery.

INTRODUCTION: To optimally target physiotherapy treatment, knowledge of the pre- and postoperative course of functional status in patients undergoing esophagectomy is required. The aim of this prospective longitudinal study was to investigate the course of functional status in patients with esophageal cancer before and after esophagectomy. MATERIALS AND METHODS: Functional status outcome measures of patients with esophageal cancer who underwent surgery between March 2012 and June 2016 were prospectively measured at 3 months and at 1 day before surgery and at 1 week and at 3 months after surgery. Analysis of repeated measurements with the mixed model approach was used to study changes over time. RESULTS: Hundred fifty-five patients were measured at 3 months and at 1 day before surgery, of which 109 (70.3%) at 1 week and 60 (38.7%) at 3 months after surgery. Mean (SD) age at surgery was 63.5 years (9.3), and 122 patients (78.7%) were male. The incidence of postoperative complications was 83 (53.5%). Three months postoperatively, functional status measures returned to baseline levels, except from handgrip strength (beta [95% CI] -6.2 [-11.3 to -1.1]; P = 0.02) and fatigue (4.7 [0.7to 8.7]; P = 0.02). No differences were observed in the course of functional status between patients with and without postoperative complications. CONCLUSION: Functional status of patients undergoing esophagectomy returned to baseline values three months after surgery, despite the high incidence of postoperative complications. This requires rethinking the concept of prehabilitation, where clearly not all patients benefit from high functional status to prevent postoperative complications.

Process evaluation of a tailored work-related support intervention for patients diagnosed with gastrointestinal cancer.

PURPOSE: To perform a process evaluation of a tailored work-related support intervention for patients diagnosed with gastrointestinal cancer. METHODS: The intervention comprised three tailored psychosocial work-related support meetings. To outline the process evaluation of this intervention, we used six key components: recruitment, context, reach, dose delivered, dose received and fidelity. Data were collected using questionnaires, checklists and research logbooks and were analysed both quantitatively and qualitatively. RESULTS: In total, 16 hospitals, 33 nurses and 7 oncological occupational physicians (OOPs) participated. Analysis of the six key components revealed that the inclusion rate of eligible patients was 47%. Thirty-eight intervention patients were included: 35 actually had a first meeting, 32 had a second and 17 had a third. For 31 patients (89%), the first meeting was face to face, as per protocol. However, in only 32% of the cases referred to support type A (oncological nurse) and 13% of the cases referred to support type B (OOP), the first meeting was before the start of the treatment, as per protocol. The average duration of the support type A meetings was around the pre-established 30 min; for the OOPs, the average was 50 min. Protocol was easy to follow according to the healthcare professionals. Overall, the patients considered the intervention useful. CONCLUSIONS: This study has shown that the strategy of tailored work-related support is appreciated by both patients and healthcare professionals and applicable in clinical practice. IMPLICATIONS FOR CANCER SURVIVORS: The intervention was appreciated by patients; however, whether the timing of the work-related support was adequate (i.e. before treatment was started) requires further research. TRIAL REGISTRATION: NTR5022.

The Successful Return-To-Work Questionnaire for Cancer Survivors (I-RTW_CS): Development, Validity and Reproducibility.

BACKGROUND: Cancer survivors' perspectives on a successful return to work (RTW) may not be captured in the common measure of RTW, namely time until RTW. OBJECTIVE: The purpose of this study was therefore to develop an RTW outcome measure that reflects employed cancer survivors' perspectives, with items that could be influenced by an employer, i.e. the Successful Return-To-Work questionnaire for Cancer Survivors (I-RTW_CS), and to assess its construct validity and reproducibility. METHODS: First, three focus groups with cancer survivors (n = 14) were organized to generate issues that may constitute successful RTW. Second, a two-round Delphi study among 108 cancer survivors was conducted to select the most important issues. Construct validity of the I-RTW_CS was assessed using correlations with a single-item measure of successful RTW and the Quality of Working Life Questionnaire for Cancer Survivors (QWLQ-CS; n = 57). Reproducibility (test-retest reliability) was assessed using the intraclass correlation coefficient (ICC; n = 50). RESULTS: Forty-eight issues were generated, of which seven were included: 'enjoyment in work'; 'work without affecting health'; 'confidence of employer without assumptions about work ability'; 'open communication with employer'; 'feeling welcome at work'; 'good work-life balance'; and 'joint satisfaction with the situation (employer and cancer survivor)'. Correlations with single-item successful RTW and QWLQ-CS were 0.58 and 0.85, respectively. The reproducibility showed an ICC of 0.72. CONCLUSIONS: The I-RTW_CS provides an RTW outcome measure that includes cancer survivors' perspectives and weights its items on an individual basis, allowing a more meaningful evaluation of cancer survivors' RTW. This study provides preliminary evidence for its construct validity and reproducibility.

Decreased peritoneal tissue plasminogen activator during prolonged laparoscopic surgery.

BACKGROUND: Peritoneal fibrinolysis is crucial in the peritoneal healing processes and subsequent adhesion formation. During conventional surgery, the peritoneal fibrinolytic system is rapidly disturbed. Short-term laparoscopy does not seem to affect peritoneal fibrinolysis. The aim of the present study was to assess the effect of prolonged laparoscopic surgery on peritoneal fibrinolysis. METHODS: Twelve consecutive patients undergoing laparoscopic gastric bypass surgery for morbid obesity were included in the study. During the procedure, biopsies of the parietal peritoneum were taken at the start of the procedure and each 45 min afterward. Tissue samples were homogenized and tissue-type plasminogen activator (tPA) antigen, tPA activity, urokinase-type PA antigen, and plasminogen activating inhibitors type 1 antigen were measured using commercial assay techniques. RESULTS: Both tPA antigen and its activity progressively decreased during the procedure, reaching significant levels after 90 min of surgery. The levels of uPA antigen and plasminogen activating inhibitors antigen did not significantly change throughout the procedure. CONCLUSIONS: As for conventional surgery, prolonged laparoscopic surgery causes a decreased fibrinolytic activity in the peritoneum due to decreased tPA levels.

Surgical treatment of hidradenitis suppurativa with gentamicin sulfate: a prospective randomized study.

BACKGROUND AND METHOD: This article describes and discusses a prospective randomized study with gentamicin sulfate in the surgical treatment of hidradenitis suppurativa. The purpose of the study was to investigate whether enclosure of antibiotics after primary excision and closure reduces the number of postoperative infections. Therefore, the hidradenitis lesions were excised and closed with or without enclosure of a gentamicin-collagen sponge (GC). RESULTS: A total of 200 patients were included in the study. Seventy-six patients underwent surgical excision with primary closure (PC), and 124 PCs over a GC. After 1 week there were significantly fewer complications (infection, dehiscence, etc.) in the GC group, 35% versus 52%; after 3 months the complications in both groups were comparable, 12% versus 19% (Table 2). The mean period of wound healing was 21 days in the first group and 24 days in the second group. The recurrence rate after 3 months was comparable in both groups, 40% versus 42%. CONCLUSION: This study shows that enclosure of gentamicin after primary excision of hidradenitis suppurativa reduces the number of complications 1 week postoperatively. Furthermore, in 65% of the patients treated with gentamicin, the wound was completely healed within 2 months. There is no effect on the long term recurrence rate, as expected.

Peritoneal transforming growth factor beta-1 expression during laparoscopic surgery: a clinical trial.

BACKGROUND: Transforming growth factor-beta 1 (TGF-beta1) is a growth factor involved in various biologic processes, including peritoneal wound healing and dissemination of malignancies. Laparoscopic surgery is evolving rapidly, and indications are increasing. The peritoneal TGF-beta1 expression during laparoscopic surgery is unknown. METHODS: For this study, 50 patients scheduled for laparoscopic cholecystectomy were randomized into five groups, then surgically treated with various pressures, light intensities, and dissection devices. Peritoneal biopsies were taken at the beginning and end of surgery. Tissue concentrations of total and active TGF-beta1 were measured using enzyme-linked immunosorbent assay (ELISA) techniques. RESULTS: There was no significant difference in either total or active TGF-beta1 concentration between peritoneal biopsies taken at the start of surgery and samples taken at the end of the procedure. Patients who underwent surgery with the ultrasonic scalpel had significant lower levels of both active (p < 0.005) and total (p < 0.01) TGF-beta1 at the end of surgery than patients treated with electrocautery. Patients who had surgery with a high light intensity had significantly lower levels of total TGF-beta1 levels (p < 0.005) with an unchanged active part than patients who had surgery with low light intensity. CONCLUSION: The choice of dissection device and the light intensity used in laparoscopic surgery affect peritoneal TGF-beta1 concentrations, indicating that peritoneal biology can be affected by laparoscopic surgery. Because TGF-beta1 is involved in various biologic processes in the peritoneal cavity, this observation may have important clinical consequences.

Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial).

BACKGROUND: Surgery in patients with obstructive jaundice caused by a periampullary (pancreas, papilla, distal bile duct) tumor is associated with a higher risk of postoperative complications than in non-jaundiced patients. Preoperative biliary drainage was introduced in an attempt to improve the general condition and thus reduce postoperative morbidity and mortality. Early studies showed a reduction in morbidity. However, more recently the focus has shifted towards the negative effects of drainage, such as an increase of infectious complications. Whether biliary drainage should always be performed in jaundiced patients remains controversial. The randomized controlled multicenter DROP-trial (DRainage vs. Operation) was conceived to compare the outcome of a 'preoperative biliary drainage strategy' (standard strategy) with that of an 'early-surgery' strategy, with respect to the incidence of severe complications (primary-outcome measure), hospital stay, number of invasive diagnostic tests, costs, and quality of life. METHODS/DESIGN: Patients with obstructive jaundice due to a periampullary tumor, eligible for exploration after staging with CT scan, and scheduled to undergo a "curative" resection, will be randomized to either "early surgical treatment" (within one week) or "preoperative biliary drainage" (for 4 weeks) and subsequent surgical treatment (standard treatment). Primary outcome measure is the percentage of severe complications up to 90 days after surgery. The sample size calculation is based on the equivalence design for the primary outcome measure. If equivalence is found, the comparison of the secondary outcomes will be essential in selecting the preferred strategy. Based on a 40% complication rate for early surgical treatment and 48% for preoperative drainage, equivalence is taken to be demonstrated if the percentage of severe complications with early surgical treatment is not more than 10% higher compared to standard treatment: preoperative biliary drainage. Accounting for a 10% dropout, 105 patients are needed in each arm resulting in a study population of 210 (alpha = 0.95, beta = 0.8). DISCUSSION: The DROP-trial is a randomized controlled multicenter trial that will provide evidence whether or not preoperative biliary drainage is to be performed in patients with obstructive jaundice due to a periampullary tumor.