TUmor-volume to breast-volume RAtio for improving COSmetic results in breast cancer patients (TURACOS); a randomized controlled trial.

BACKGROUND: Cosmetic result following breast conserving surgery (BCS) for cancer influences quality of life and psychosocial functioning in breast cancer patients. A preoperative prediction of expected cosmetic result following BCS is not (yet) standard clinical practice and therefore the choice for either mastectomy or BCS is still subjective. Recently, we showed that tumour volume to breast volume ratio as well as tumour location in the breast are independent predictors of superior cosmetic result following BCS. Implementation of a prediction model including both factors, has not been studied in a prospective manner. This study aims to improve cosmetic outcome by implementation of a prediction model in the treatment decision making for breast cancer patients opting for BCS. METHODS/DESIGN: Multicentre, single-blinded, randomized controlled trial comparing standard preoperative work-up to a preoperative work-up with addition of the prediction model. Tumour volume to breast volume ratio and tumour location in the breast will be used to predict cosmetic outcome in invasive breast cancer patients opting for BCS. Three dimensional (3D)-ultrasonography will be used to measure the tumour volume to breast volume ratio needed for the prediction model. Sample size was estimated based on a 14% improvement in incidence of superior cosmetic result one year after BCS (71% in the control group versus 85% in the intervention group). Primarily cosmetic outcome will be evaluated by a 6-member independent panel. Secondary endpoints include; (1) patient reported outcome measured by BREAST-Q, EORTC-QLQ-C30/BR23 and EQ-5D-5 L (2) cosmetic outcome as assessed through the BCCT.core software, (3) radiation-induced reaction (4) surgical treatment performed, (5) pathological result and (6) cost-effectiveness. Follow-up data will be collected for 3 years after surgery or finishing radiotherapy. DISCUSSION: This randomized controlled trial examines the value of a preoperative prediction model for the treatment-decision making. It aims for a superior cosmetic result in breast cancer patients opting for BCS. We expect improvement of patients' quality of life and psychosocial functioning in a cost-effective way. TRIAL REGISTRATION: Prospectively registered, February 17th 2015, at 'Nederlands Trialregister - NTR4997 '.

Reliability and validity of the Dutch-translated Body Image Scale.

PURPOSE: Lacking a comprehensible and widely applicable Dutch test to assess body image changes in cancer patients, we validated Hopwood's Body Image Scale (BIS) for the Dutch language. METHODS: The BIS consists of 10 items scored 0-3. Total scores range from 0 (minimum body image-related distress) to 30 (maximum distress). After forward and backward translation of the BIS, we evaluated its psychometric characteristics in breast cancer patients. We assessed feasibility by missing answer rates and positive response prevalence (score ≥ 1) per item (criterion ≥ 30 %), test-retest reliability with a 2-week interval, internal consistence using Cronbach's α and discriminant ability by comparing body image after breast-conserving therapy (BCT) versus mastectomy. RESULTS: Psychometric evaluation of 108 BCT and 101 mastectomy patients showed high feasibility (0.2 % missing answers), high positive response prevalence of ≥ 30 % in 9/10 items and high internal consistency (α > 0.90). Test-retest reliability and correlation were high with 5.78 (test) versus 5.75 (retest; P = 0.86) and Spearman's ρ = 0.92 (P < 0.01). Discriminant ability was good with BIS scores of 4.56 after BCT versus 7.19 after mastectomy (P < 0.01). All results were comparable to the results of the original BIS. CONCLUSION: The Dutch-translated BIS showed excellent psychometric results very similar to the original BIS. Its concise and simple design further supports wide application in clinical practice.

Adhesion prevention during laparotomy: long-term follow-up of a randomized clinical trial.

OBJECTIVE: The objective of the study was to determine the long-term effect of the use of a hyaluronic acid-carboxymethylcellulose membrane (Seprafilm) on the incidence of adhesions and subsequent small-bowel obstruction and chronic abdominal complaints after colorectal surgery (Hartmann's procedure). BACKGROUND: Adhesions occur frequently after abdominal surgery and are the most common cause of bowel obstruction, chronic abdominal pain, and infertility. The risk for adhesion-related readmission in the first 10 years after colorectal surgery is as high as 30%. To reduce the formation of adhesions, a mechanical barrier composed of hyaluronic acid and carboxymethylcellulose was developed, to prevent adherence of tissues after abdominal surgery. Long-term results concerning the incidence of small-bowel obstruction and chronic abdominal pain are lacking. METHODS: Between April 1996 and September 1998, 71 patients requiring Hartmann's procedure for sigmoid diverticulitis or obstructed rectosigmoid were randomized to either intraperitoneal placement of Seprafilm under the midline and in the pelvis or as a control. Direct visual evaluation of the incidence and severity of adhesions was performed laparoscopically in 42 patients at second-stage surgery for restoration of the continuity of the colon. The results of this study were published in 2002. In 2006, the patients' general practitioners were interviewed by means of a questionnaire concerning their patients' health. The patients who were still alive were interviewed and asked to fill out 2 questionnaires concerning pain and quality of life (VAS-pain score, EQ-5D, and SF-36). In 2009, the medical records of the patients were evaluated for adhesion-related hospital re-admissions. RESULTS: Of the 42 evaluated patients, 35 (16 in the Seprafilm group, 19 in the control group) could be enrolled in the long-term follow-up. Median follow-up was 126 months (range 41-148) for the Seprafilm group and 128 months (range 49-149) months for the control group. Incidence of chronic (3 months or longer existing) abdominal complaints was significantly lower in the Seprafilm group compared with controls (35.3% vs. 77.8%, respectively; P = 0.018). Incidence of small-bowel obstruction showed no significant difference in favor of the Seprafilm group; no small-bowel obstructions occurred in the Seprafilm group, whereas in the control group 2 cases of small-bowel obstruction were found to have occurred. Evaluation of the quality of life questionnaires did not reveal significant differences between the 2 groups. CONCLUSIONS: In Hartmann's procedure, Seprafilm placement does not provide protection against small-bowel obstruction. Incidence of chronic abdominal complaints is significantly lower after use of Seprafilm.

Advanced glycation end products as a biomarker for incisional hernia.

BACKGROUND: Incisional hernia is one of the most frequent complications after abdominal surgery, with incidences up to 30%. A reliable biomarker for the prediction of this complication is lacking. Advanced glycosylation end products (AGEs), also known as non-enzymatic collagen crosslinks, are correlated with aging, smoking, hyperglycemia, hyperlipidemia and oxidative stress. In this study the accumulation of AGEs and the relation between AGEs and incisional hernia were investigated. MATERIALS AND METHODS: In an exploratory case-control study, 23 patients with incisional hernia after midline incision were compared with 17 patients without clinical or radiological signs of incisional hernia after midline incision, AGEs were measured using a Skin Auto Fluorescence (SAF)-reader. RESULTS: Twenty-three patients with a clinically significant incisional hernia and 17 control patients were included. The study groups had significant differences in mean BMI. There was a significant difference between mean AGEs in patients with and without incisional hernia after midline incision (3.00 ± 0.15 vs. 2.56 ± 0.11, T test p = 0.03). CONCLUSION: AGE accumulation measured in the skin indirectly with autofluorescence might be associated with incisional hernia. Prospective larger trials should confirm this finding.

[Preventive contralateral mastectomy despite absence of gene mutation; management and treatment of women with no medical indication]. / Geen aangetoonde genmutatie, maar toch preventieve contralaterale mastectomie.

Recently, there has been an increase in the rate of contralateral prophylactic mastectomies (CPM) as a therapy for breast cancer. The CPM is performed to achieve a reduction in the risk of developing asecond breast cancer. However, evidence is lacking for beneficial survival outcomes after a CPM in patients without a gene mutation, and complications of surgery are inevitable. Currently there are no evidence-based clinical practice guidelines available for clinicians to decide upon the right treatment for patients without a gene mutation. Our hospitals have therefore implemented their own clinical pathway to achieve a comprehensive treatment for this group of patients. In this article we will provide an overview of the existing literature and illustrate our clinical pathway by presenting three patients treated in our hospitals in the last two years.

Prosthetic mesh repair should be used for any defect in the abdominal wall.

The case for mesh versus non-mesh repair of defects in the abdominal wall is argued, with the conclusion that the evidence-base is sufficiently strong to recommend that that all defects in the abdominal wall, whether inguinal, incisional or umbilical hernias, and of whatever size, should be repaired with the use of prosthetic mesh.

Abdominal adhesions: intestinal obstruction, pain, and infertility.

Adhesions cause bowel obstruction, chronic abdominal pain, and infertility. In this review, the incidence, clinical signs, diagnostic procedures, and treatment of these sequels of abdominal surgery are discussed. Laparoscopic treatment of bowel obstruction, chronic pain, and infertility is feasible in selected patients and has been reported to cause fewer newly formed adhesions. Randomized controlled trials to compare open and laparoscopic surgery for adhesions should be executed with long-term follow-up to assess the success rates of adhesiolysis and compare the morbidity and mortality.

Radiofrequency ablation for early-stage breast cancer: treatment outcomes and practical considerations.

BACKGROUND: Radiofrequency ablation (RFA) for early-stage breast cancer has the potential advantage of being a less invasive treatment associated with improved cosmetic outcome. The aim of this review was to summarise the reported treatment outcomes of ultrasound-guided RFA for early-stage breast cancer and to highlight practical considerations with regard to this treatment. METHODS: A search of the English-language literature concerning RFA for breast cancer treatment was performed. RESULTS: RFA is a technique that can be safely applied in patients with early-stage breast cancer, which is restricted to cT1-T2N0 ductal carcinoma with radiologically defined borders without any signs of multifocality or multicentricity. However, before RFA can be adopted as local therapy for early-stage breast cancer, more research is needed to assess the post-treatment pathological complete response and margin status, the long-term oncologic outcome in comparison to current standard breast conserving therapy and the potential cosmetic superiority of percutaneous RFA. CONCLUSION: RFA appeared to be a feasible technique for the treatment of early-stage breast cancer, but considerable practical considerations form an obstacle to introduce RFA as a standard of care.

Treatment outcome in breast cancer patients with ipsilateral supraclavicular lymph node metastasis at time of diagnosis: a review of the literature.

INTRODUCTION: In the revised 6th edition of the AJCC-TNM staging system for breast cancer, metastasis in ipsilateral supraclavicular lymph node(s) is considered as a locoregional disease and classified as N3c rather than M1 distant disease. The aim of this review was to search the recent literature in order to investigate whether the reported treatment outcome of patients with ipsilateral supraclavicular metastases in breast cancer patients justifies this revision. METHODS: A review of the recent English-language literature (January 2001-June 2012) concerning breast cancer with supraclavicular involvement was performed. RESULTS: A total number of six studies were included in the current review. All reported comparable data with regard to treatment outcome after multimodality treatment, despite considerable heterogeneity in study populations. Patients with ipsilateral supraclavicular lymph node involvement showed outcomes more similar to locally advanced breast cancer patients rather than patients with distant tumor spread. CONCLUSION: It seems that the 2002 revision of the AJCC-TNM staging system for breast cancer has appropriately reclassified patients with supraclavicular disease to a new category (N3c).

Benzopyrene serum concentration after endovenous laser ablation of the great saphenous vein.

BACKGROUND: During endovenous laser ablation (EVLA) of the great saphenous vein, patients often involuntarily mention an uncomfortable "burnt" smell and taste. When applying intense heat to proteins and carbohydrates, it is inevitable that polycyclic aromatic hydrocarbons (PAHs) are formed. This group of PAH includes the human carcinogen benzo[a]pyrene (B[a]P). This study determined the serum concentration of B[a]P just before and after EVLA. METHODS: A total of 20 patients were included. The B[a]P serum concentration was determined just before and directly after EVLA. RESULTS: In 18 patients, B[a]P was determined before and after EVLA. In 2 patients, EVLA was not possible. In this study, no elevated serum concentration of B[a]P was found before and after EVLA. CONCLUSION: It remains to be established which heat products cause the burnt smell and taste sensation in patients during EVLA. Further research is needed to determine whether EVLA can be considered as a safe procedure.

Proposal for a multidisciplinary approach to the patient with morbid obesity: the St. Franciscus Hospital morbid obesity program.

Morbid obesity is a serious disease as it is accompanied by substantial co-morbidity and mortality. The prevalence is increasing to an alarming extent, in Europe as well as in the United States. In the past few decades, bariatric surgery has developed and gained importance. It currently represents the only long-lasting therapy for this group of patients, resulting in an efficient reduction in body weight and obesity-related medical conditions, mostly cardiovascular in nature. The importance of a standardized protocol, the use of selection criteria, and a multidisciplinary approach have been stressed but not yet described in detail. Therefore, in this article, the multidisciplinary approach and the treatment protocol that have been applied in our hospital for more than 20 years are set out in a detailed manner. The application of a strict protocol may help to select and follow-up motivated patients and to organize multidisciplinary research activities.

Long-term follow-up of a randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia.

BACKGROUND: Prospective studies and meta-analyses have indicated that non-mesh repair is inferior to mesh repair based on recurrence rates in inguinal hernia. The only reliable way to evaluate recurrence rates after hernia surgery is by long-term follow-up. METHODS: Between September 1993 and January 1996, a multicentre clinical trial was performed, in which 300 patients with unilateral primary inguinal hernia were randomized to non-mesh or mesh repair. Long-term follow-up was carried out from June 2005 to January 2006. RESULTS: Median follow-up was 128 months for non-mesh and 129 months for mesh repair. The 10-year cumulative hernia recurrence rates were 17 and 1 per cent respectively (P = 0.005). Half of the recurrences developed after 3 years' follow-up. There was no significant correlation between hernia recurrence and age, level of expertise of the surgeon, contralateral hernia, obesity, history of pulmonary disease, constipation or prostate disease. CONCLUSION: After 10 years mesh repair is still superior to non-mesh hernia repair. Recurrence rates may be underestimated as recurrences continue to develop for up to 10 years after surgery.

Intraperitoneal polypropylene mesh repair of incisional hernia is not associated with enterocutaneous fistula.

BACKGROUND: Incisional hernia repair with prosthetic material is followed by fewer recurrences than primary repair. Polypropylene is the most commonly used prosthetic material but may cause entero- cutaneous fistulas. The aim of this study was to determine whether enterocutaneous fistulas developed after incisional hernia repair with polypropylene mesh and to evaluate clinical outcome after incisional hernia repair. METHODS: A retrospective analysis of the outcome of incisional hernia repair with polypropylene mesh between 1982 and 1998 was conducted. Follow-up data were obtained from medical records and questionnaires. RESULTS: Polypropylene incisional hernia repair was performed in 136 patients. Median follow-up was 34 months. No enterocutaneous fistulas developed. Wound infection occurred in 6 per cent. Wound sinus formation occurred in two patients. No mesh was removed because of infection and no persisting infection of the mesh occurred. CONCLUSION: Enterocutaneous fistula formation appears to be very rare after incisional hernia repair with polypropylene mesh, regardless of intraperitoneal placement, omental coverage or closing of the peritoneum.

Peritoneal adhesions to prosthetic materials: choice of mesh for incisional hernia repair.

BACKGROUND: In many cases, incisional hernia repair requires the use of prosthetic materials. The aim of this experimental study in a rat model was to assess the role of polyglactin 910 mesh and fluoropassivated polyester mesh in preventing the formation of adhesions. METHODS: In the first experiment, the formation of peritoneal adhesions was assessed after insertion of polypropylene, polypropylene combined with polyglactin 910, or no mesh. In the second experiment, adhesion formations were compared after insertion of fluoropassivated polyester, polypropylene, and no mesh. RESULTS: The first experiment showed no significant difference in adhesion formations between the polypropylene mesh and the combined mesh; however, when no mesh was used, there were significantly fewer adhesions in both experiments (p < 0.01). The second experiment showed a significantly lower degree of adhesions and a lower Adhesion Index after insertion of fluoropassivated polyester mesh than when polypropylene mesh was used (p = 0.04). CONCLUSIONS: Adding polyglactin 910 mesh to polypropylene mesh to prevent the formation of adhesions is not an effective measure. Fluoropassivated polyester meshes appear to provide a better alternative to the use of polypropylene meshes for incisional hernia repair in humans in terms of the formation of adhesions.

Mesh repair of incisional hernia: comparison of laparoscopic and open repair.

OBJECTIVE: To compare our results of open and laparoscopic mesh repair of incisional hernias. DESIGN: Retrospective cohort study. SETTING: Teaching hospitals, The Netherlands. SUBJECTS: All patients who had had a laparoscopic (n = 25) or an open (n = 76) mesh repair of incisional hernia between January 1996 and January 2000. INTERVENTIONS: Physical examination at the time of the study. MAIN OUTCOME MEASURES: Morbidity and recurrence. RESULTS: The groups were comparable. 11 patients (14%) developed postoperative infections after open repair and 1 (4%) after laparoscopic repair (p = 0.29). Median hospital stay was 5 days (range 1-19) in the open group and 4 (range 1-11) in the laparoscopic group (p = 0.28). The 2-year cumulative incidence of recurrence was 18% after open repair (median follow-up of 17 months (range 1-46) and 15% after laparoscopic repair (median follow-up of 15 months, range 1-44). Recurrences in the laparoscopic group were all among the first 7 cases in which the mesh was fixed with staples alone. CONCLUSION: There were fewer infections and hospital stay was shorter in the laparoscopic group, but not significantly so. Recurrence rates were comparable.

Size of lesion is not a criterion for resection during management of giant liver haemangioma.

BACKGROUND: The unknown natural history and risk of complications of large haemangiomas may pose therapeutic dilemmas. The authors describe their experience with the management of giant haemangiomas. METHODS: Patients with a giant haemangioma were identified by a survey of the hospital database. Forty-nine patients with a haemangioma of at least 4 cm in diameter presented between January 1990 and December 2000. Medical records were analysed retrospectively. RESULTS: Eleven patients had surgical treatment and 38 were managed conservatively. The median diameter of the tumours was 8.0 cm in surgically treated patients and 6.0 cm in the group managed by observation. Surgery-related morbidity occurred in three patients, and abdominal complaints persisted in three of ten patients with a symptomatic lesion. During a median follow-up of 52 months, 12 non-operated patients had mild abdominal complaints, considered to be unrelated to the lesion. In these patients symptoms either diminished or became minimal during follow-up. Complications did not occur. CONCLUSION: Observation of giant haemangiomas can be performed safely. The authors advocate resection of cavernous liver haemangiomas only in patients with persistent severe symptoms.

Randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia.

BACKGROUND: The optimum method for inguinal hernia repair has not yet been determined. The recurrence rate for non-mesh methods varies between 0.2 and 33 per cent. The value of tension-free repair with prosthetic mesh remains to be confirmed. The aim of this study was to compare mesh and non-mesh suture repair of primary inguinal hernias with respect to clinical outcome, quality of life and cost in a multicentre randomized trial in general hospitals. METHODS: Between September 1993 and January 1996, all patients scheduled for repair of a unilateral primary inguinal hernia were randomized to non-mesh or mesh repair. The patients were followed up at 1 week and at 1, 6, 12, 18, 24 and 36 months. Clinical outcome, quality of life and costs were registered. RESULTS: Three hundred patients were randomized of whom 11 were excluded. Three-year recurrence rates differed significantly: 7 per cent for non-mesh repair (n = 143) and 1 per cent for mesh repair (n = 146) (P = 0.009). There were no differences in clinical variables, quality of life and costs. CONCLUSION: Mesh repair of primary inguinal hernia repair is superior to non-mesh repair with regard to hernia recurrence and is cost-effective. Postoperative complications, pain and quality of life did not differ between groups.