Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial).

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.

Longitudinal trajectories and psychological predictors of weight loss and quality of life until 3 years after metabolic and bariatric surgery.

OBJECTIVE: This study aimed to describe longitudinal trajectories of Total Weight Loss (%TWL), and mental and physical health related quality of life (HRQOL), as well as to identify preoperative psychological predictors of these trajectories. METHODS: A prospective observational study including Dutch patients treated with metabolic and bariatric surgery (n = 420, age 44.8 ± 10.3 years, 78.6% females) was performed. Trajectories of %TWL and HRQOL from screening to 1-, 2-, and 3-years post-surgery were described using growth mixture modelling. Multivariable and lasso regression models were used to identify predictors. RESULTS: Three trajectories described %TWL, varying in the degree of first-year weight loss. No pre-surgical psychological factors were associated with %TWL trajectories. We identified four physical and five mental HRQOL trajectories. Approximately 25-30% of patients exhibited patterns of initial improvements followed by decline, or persistently low levels of HRQOL. Higher depressive symptoms were associated with these unfavourable physical HRQOL trajectories (OR 1.20, 95%CI 1.04-1.39), adjusted for confounders. Unfavourable mental HRQOL trajectories were predicted by depressive and anxiety symptoms, neuroticism, insecure attachment, and maladaptive coping. In contrast, self-esteem, extraversion, and conscientiousness were associated with favourable mental HRQOL trajectories. DISCUSSION: Psychological factors did not predict weight loss, but they significantly impacted patient's HRQOL after metabolic and bariatric surgery. A subgroup with unsuccessful HRQOL after surgery was identified, who would benefit from tailored preoperative counselling to optimize surgery outcomes. Metabolic and bariatric surgery may not be universally beneficial for all patients, challenging the conventional approach to surgical interventions for severe obesity and advocating for a more nuanced, individualized assessment of potential candidates.

Learning Curves of Ivor Lewis Totally Minimally Invasive Esophagectomy by Hospital and Surgeon Characteristics: A Retrospective Multinational Cohort Study.

OBJECTIVE: To describe the pooled learning curves of Ivor Lewis totally minimally invasive esophagectomy (TMIE) in hospitals stratified by predefined hospital- and surgeon-related factors. BACKGROUND: Ivor Lewis (TMIE is known to have a long learning curve which is associated with considerable learning associated morbidity. It is unknown whether hospital and surgeon characteristics are associated with more efficient learning. METHODS: A retrospective analysis of prospectively collected data of consecutive Ivor Lewis TMIE patients in 14 European hospitals was performed. Outcome parameters used as proxy for efficient learning were learning curve length, learning associated morbidity, and the plateau level regarding anastomotic leakage and textbook outcome. Pooled incidences were plotted for the factor-based subgroups using generalized additive models and 2-phase models. Casemix predicted outcomes were plotted and compared with observed outcomes. The investigated factors included annual volume, TMIE experience, clinic visits, courses and fellowships followed, and proctor supervision. RESULTS: This study included 2121 patients. The length of the learning curve was shorter for centers with an annual volume >50 compared to centers with an annual volume <50. Analysis with an annual volume cut-off of 30 cases showed similar but less pronounced results. No outcomes suggesting more efficient learning were found for longer experience as consultant, visiting an expert clinic, completing a minimally invasive esophagectomy fellowship or implementation under proctor supervision. CONCLUSIONS: More efficient learning was observed in centers with higher annual volume. Visiting an expert clinic, completing a fellowship, or implementation under a proctor's supervision were not associated with more efficient learning.

Laparoscopic transdiaphragmatic pericardial fenestration in palliative care: how I do it.

BACKGROUND: The optimal therapeutic strategy for drainage of malignant pericardial effusion is not yet determined. Several techniques are described, with different benefits and disadvantages. The literature suggests that surgical drainage of pericardial effusions has less effusion recurrence; however, randomized controlled trials are not available. Due to the nature of the disease, quality of life should always be considered while making treatment decisions. METHODS: A retrospective analysis of all consecutive patients from November 2016 until June 2019 of our institution in the Netherlands was performed. All patients underwent laparoscopic pericardial fenestration after echocardiography and request for operative treatment by the cardiologist. The same operation technique was performed in every case. RESULTS: Four out of five of our patients needed pericardial fenestration because of oncological diseases. No hemodynamically instability was noted during this fast technique, achieving direct relief of symptoms. No treatment-related morbidity or mortality, nor the need for re-intervention was encountered. We compared the outcome of our five patients with the existing evidence in the literature. CONCLUSIONS: In this article, we highlight the laparoscopic transdiaphragmatic pericardial fenestration as a treatment of preference in a non-acute palliative setting. This laparoscopic approach is safe, and can be a valuable alternative among the other well-known approaches.

Motivation and Weight Loss Expectations in Bariatric Surgery Candidates: Association with 1- and 2-Year Results After Bariatric Surgery.

PURPOSE: There are discrepancies between patients' expected weight loss and what is considered achievable after bariatric surgery. This study describes the association between patients' expectations and actual weight loss, 1 and 2 years postoperatively. MATERIALS AND METHODS: A prospective observational study was performed. The association between expectations and actual weight loss (% total weight loss) was explored using linear regression analyses, adjusting for baseline demographics, surgery types, and self-esteem (Rosenberg self-esteem scale) and repeated separately per gender. Gender differences in motivations were explored using Chi-square tests. RESULTS: Of 440 patients at baseline, results on 368 (84%) at 1 year and 341 (78%) patients at 2 years were available. Significant and opposite associations were found when analyzing genders separately. There was a significant negative association between expectations and %TWL in men at 1 year (ß - 0.23, p = 0.04) and 2 years postoperatively (ß - 0.26, p = 0.03), indicating smaller weight loss for greater expectations. In women, a significant positive association (ß 0.24, p < 0.01) was found 2 years postoperatively, indicating greater weight loss for greater expectations. Both genders were mainly motivated by health concerns, but women were also motivated by reduced self-confidence to lose weight. CONCLUSIONS: Higher expectations were negatively associated with weight loss in men, but positively in women. This may be due to men being motivated by physical complaints, which improve with lower weight-loss. Women are also driven by reduced self-confidence, which may influence weight loss maintenance behaviors. Higher weight loss goals should not be considered as a contra-indication for surgery, but may be utilized to achieve patients' goals.

Population-Based Study on Risk Factors for Tumor-Positive Resection Margins in Patients with Gastric Cancer.

BACKGROUND: Radical gastrectomy is the cornerstone of the treatment of locally advanced gastric cancer. This study was designed to evaluate factors associated with a tumor-positive resection margin after gastrectomy and to evaluate the influence of hospital volume. METHODS: In this Dutch cohort study, patients with junctional or gastric cancer who underwent curative gastrectomy between 2011 and 2017 were included. The primary outcome was incomplete tumor removal after the operation defined as the microscopic presence of tumor cells at the resection margin. The association of patient and disease characteristics with incomplete tumor removal was tested with multivariable regression analysis. The association of annual hospital volume with incomplete tumor removal was tested and adjusted for the patient- and disease characteristics. RESULTS: In total, 2799 patients were included. Incomplete tumor removal was seen in 265 (9.5%) patients. Factors associated with incomplete tumor removal were: tumor located in the entire stomach (odds ratio (OR) [95% confidence interval (CI): 3.38 [1.91-5.96] reference: gastroesophageal junction), cT3, cT4, cTx (1.75 [1.20-2.56], 2.63 [1.47-4.70], 1.60 [1.03-2.48], reference: cT0-2), pN+ (2.73 [1.96-3.80], reference: pN-), and diffuse and unknown histological subtype (3.15 [2.14-4.46] and 2.05 [1.34-3.13], reference: intestinal). Unknown differentiation grade was associated with complete tumor removal (0.50 [0.30-0.83], reference: poor/undifferentiated). Compared with a hospital volume of < 20 resections/year, 20-39, and > 39 resections were associated with lower probability for incomplete tumor removal (OR 0.56 [0.42-0.76] and 0.34 [0.18-0.64]). CONCLUSIONS: Tumor location, cT, pN, histological subtype, and tumor differentiation are associated with incomplete tumor removal. The association of incomplete tumor removal with an annual hospital volume of < 20 resections may underline the need for further centralization of gastric cancer care in the Netherlands.

Long-term Outcomes After Surgery Involving the Pelvic Floor in Rectal Cancer: Physical Activity, Quality of Life, and Health Status.

PURPOSE: This study has aimed to evaluate the effects of surgery on physical activity (PA), quality of life (QoL), and disease-specific health status, by analyzing the differences between sphincter-preserving surgery (low anterior resection (LAR)) and abdominoperineal resection (APR) among rectal cancer survivors. METHODS: Individuals who were diagnosed with rectal cancer and who underwent an APR or a LAR between 2000 and 2009 were included. The different questionnaires on QoL, disease-specific health status, and physical activity began their surveys in 2010. Differences in QoL, health status, and physical activity were analyzed between the APR group and the LAR group. RESULTS: The study included 905 rectal cancer survivors (LAR, 632; APR, 273). Besides a higher rate of radiotherapy treatment in the APR group (94% vs. 75%, p < 0.001), there were no differences in clinical characteristics or in comorbid conditions between the LAR group and APR group. No significant differences were found in PA level between the patients who had undergone an APR vs. a LAR. Regarding QoL, APR patients did report a worse physical (p = 0.009) and role functioning (p = 0.03), as well as a worse body image (p = 0.001), compared to patients who had undergone a LAR. However, they reported fewer constipation (p = 0.02) and gastrointestinal problems (p = 0.009). Finally, compared to patients who had undergone a LAR with a permanent ostomy, APR patients reported a better body image (p = 0.048) and less stoma-related problems (p = 0.001). CONCLUSIONS: This study showed no differences in PA level among the patients who had undergone an APR versus a LAR. With respect to their QoL, their physical and role functioning seemed to be worse in the APR patients. However, these differences in outcomes resolved when comparing the APR group with patients after a LAR with a permanent ostomy.

Use of Epidural Analgesia in Sigmoidectomy: Is There Any Advantage in the Era of Minimally Invasive Surgery?

BACKGROUND: There is no consensus as to the effects of epidural analgesia on postoperative outcomes after laparoscopy in the context of the Enhanced Recovery Programs. The aim of this study was to evaluate the effects of epidural analgesia on postoperative outcomes after elective laparoscopic sigmoidectomy. METHODS: The use of epidural analgesia was discontinued in elective laparoscopic sigmoidectomy and substituted by the perioperative administration of systemic lidocaine. Data from patients undergoing elective laparoscopic sigmoidectomy between January 2014 and September 2016 was prospectively analysed. Patients with epidural analgesia were compared with patients without, in analgesics administrated postoperatively, length of stay, day of first defecation and mobilisation, and complication and reoperation rates. RESULTS: A total of 160 patients (male 85; female 75), median age 68 (30-92 years), were included. The groups consisted of 80 patients each. Mean length of stay (5.6 vs. 7.2 days, p = 0.03) and day of first mobilisation (mean 1.2 vs. 1.6 days, p = 0.004) were significantly shorter in the group without epidural analgesia. Reoperation rate (7.5 vs. 2.5%) was not statistically different. Complication rate was significantly lower (12.5 vs. 30%, p = 0.007) in the group without epidural. Day of first defecation was shorter in the epidural group (1.4 vs. 1.7 days, p = 0.04). Mean amount of analgesics administrated was not statistically different between groups, except for metamizole, that was administrated more in the group without epidural. CONCLUSIONS: Epidural analgesia did not offer benefits on postoperative analgesia or outcomes after elective laparoscopic sigmoidectomy, causing longer length of stay, later mobilisation and higher complication rate.

Comparative Quality of Life in Patients Following Transanal Minimally Invasive Surgery and Healthy Control Subjects.

BACKGROUND: Transanal minimally invasive surgery (TAMIS) is considered the successor of transanal endoscopic microsurgery (TEMS). It makes use of more readily available laparoscopic instruments and single-port access platforms with similar perioperative, clinical and oncological outcomes. Little is known about quality of life (QoL) outcomes after the use of TAMIS. The aim of this study was to assess QoL after TAMIS in our patients and compare this with QoL in the healthy Dutch population. METHODS: All patients undergoing TAMIS for selected rectal neoplasms between October 2011 and March 2014 were included in this analysis. Patients were studied for a minimal period of 24 months. QoL outcomes were measured using the Short-Form 36 Health Survey (SF-36) questionnaire; faecal continence was measured using the Faecal Incontinence Severity Index questionnaire. Patient reported outcomes were compared to case-matched healthy Dutch control subjects. We hypothesise that undergoing TAMIS will subsequently result in a decreased quality of life in patients compared to healthy individuals. RESULTS: Thirty-seven patients (m:f = 17:20, median 67 years) were included in the current analysis. In four patients (10.8%), postoperative complications occurred. The median follow-up was 36 (range 21-47) months. Postoperative QoL scores are similar comparable to those reported by Dutch healthy controls. Patients reported a statistically significant better QoL score in the 'bodily pain' domain when compared to the controls (81.8 vs. 74.1 points) (p = 0.01). Significant worse QoL scores for the 'social functioning' domain were reported by patients after TAMIS (84.4 vs. 100 points) (p = 0.03). CONCLUSION: TAMIS seems to be a safe technique with postoperative QoL scores similar to that of healthy case matched controls in 3-year follow-up. There seems to be no association between faecal incontinence and reported QoL. Negative effects of TAMIS on social functioning of patients should not be underestimated and should be discussed during preoperative counselling.

Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.

BACKGROUND: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE. METHODS/DESIGN: The ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness. DISCUSSION: We hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness. TRIAL REGISTRATION: Netherlands Trial Register: NTR4333 . Registered on 23 December 2013.

Redo Laparoscopic Gastric Bypass: One-Step or Two-Step Procedure?

BACKGROUND: The adjustable gastric band (AGB) is a bariatric procedure that used to be widely performed. However, AGB failure-signifying band-related complications or unsatisfactory weight loss, resulting in revision surgery (redo operations)-frequently occurs. Often this entails a conversion to a laparoscopic Roux-en-Y gastric bypass (LRYGB). This can be performed as a one-step or two-step (separate band removal) procedure. METHODS: Data were collected from patients operated from 2012 to 2014 in a single bariatric centre. We compared 107 redo LRYGB after AGB failure with 1020 primary LRYGB. An analysis was performed of the one-step vs. two-step redo procedures. All redo procedures were performed by experienced bariatric surgeons. RESULTS: No difference in major complication rate was seen (2.8 vs. 2.3 %, p = 0.73) between redo and primary LRYGB, and overall complication severity for redos was low (mainly Clavien-Dindo 1 or 2). Weight loss results were comparable for primary and redo procedures. The one-step and two-step redos were comparable regarding complication rates and readmissions. The operating time for the one-step redo LRYGB was 136 vs. 107.5 min for the two-step (median, p < 0.001), excluding the operating time of separate AGB removal (mean 61 min, range 36-110). CONCLUSIONS: Removal of a failed AGB and LRYGB in a one-step procedure is safe when performed by experienced bariatric surgeons. However, when erosion or perforation of the AGB occurs, we advise caution and would perform the redo LRYGB as a two-step procedure. Equal weights can be achieved at 1 year post redo LRYGB as after primary LRYGB procedures.

Early Postoperative Progression to Solid Foods Is Safe After Roux-en-Y Gastric Bypass.

BACKGROUND: Even though admission time is reduced with the implementation of various enhanced recovery protocols, many clinics still instruct patients after weight loss surgery to maintain a fluid or minced-food diet for at least 2 weeks postoperatively. We reasoned that with adequate preoperative instructions, including adequate chewing of all foods, early progression to solid foods would not increase the risk of (gastro)enterostomy leakage. METHODS: In December 2010, a new dietary protocol was implemented for all patients undergoing a Roux-en-Y gastric bypass, allowing progression to solid foods from 12 h postprocedure onwards. All patients received thorough preoperative eating instructions and eating awareness counselling from a qualified dietician and psychologist. A retrospective study was performed of 936 patients who underwent a primary or redo laparoscopic Roux-en-Y gastric bypass between January 2011 and June 2014 in our hospital. All 30-day complications, readmissions and reoperations were noted. RESULTS: No 30-day loss to follow-up occurred. Overall 30-day complication rate was 9.4%, with gastrointestinal leakage occurring in only 0.6%. A low threshold for readmission was maintained due to the short mean admission time of 1.87 days. Readmission rate was 4.8%--mainly for observation of postoperative pain--and 1.8% of our patients required reoperation within 30 days. Mortality was 0.1%. Our results are comparable to results published by other Dutch centres advocating conventional diets, showing no increase in leakage or other complications. CONCLUSIONS: We conclude that early progression to solid foods after Roux-en-Y gastric bypass surgery is a feasible alternative as no increase in complications is observed.

Biopsychosocial predictors of sexual function and quality of sexual life: a study among patients with colorectal cancer.

OBJECTIVE: A low sexual function (SF) has been reported in patients with colorectal cancer. However, research often focusses on clinical predictors of SF, hereby omitting patients' subjective evaluation of SF [i.e., the quality of sexual life (QoSL)] and psychosocial predictors of SF and QoSL. In addition, research incorporating a biopsychosocial approach to SF and QoSL is scarce. Therefore, this study aimed to evaluate (I) relatedness between SF and the QoSL, (II) the course of SF and QoSL, and (III) biopsychosocial predictors of SF and QoSL. METHODS: Patients completed questionnaires assessing sociodemographic factors (i.e., age, sex) and personality characteristics (i.e., neuroticism, trait anxiety) before surgery. Questionnaires assessing psychological (i.e., anxious and depressive symptoms, body image, fatigue) and social (i.e., sexual activity, SF, non-sensuality, avoidance of sexual activity, non-communication, relationship function) aspects were measured preoperative and 3, 6, and 12 months after surgery. Clinical characteristics were obtained from the Eindhoven Cancer Registry (ECR). Bivariate correlations evaluated relatedness between SF and QoSL. Linear mixed-effects models examined biopsychosocial predictors of SF and QoSL. RESULTS: SF and QoSL are related constructs (r=0.206 to 0.642). Compared to preoperative scores, SF did not change over time (P>0.05). Overall, patients' QoSL decreased postoperatively (P=0.001). A higher age (ß=-0.02, P=0.006), fatigue (ß=-0.02, P=0.034), not being sexually active (ß=-0.081, P<0.001), and having a stoma (ß=0.37, P=0.035) contributed to a lower SF. Having rectal cancer (ß=-1.64, P=0.003), depressive symptoms (ß=-0.09, P=0.001), lower SF (ß=1.05, P<0.001), and more relationship maladjustment (ß=-0.05, P=0.027) contributed to a lower QoSL (P<0.05). In addition, partners' SF (ß=0.24, P<0.001) and QoSL (ß=0.30, P<0.001) were predictive for patients' SF and QoSL, respectively. A significant interaction between time and gender was reported for both outcomes (P's=0.002). CONCLUSIONS: SF and QoSL are related but distinctive constructs. The course of SF and QoSL differed. Different biopsychosocial predictors were found for SF and QoSL. The contribution of partner-related variables to patients' outcomes suggests interdependence between patients and partners. Men and women showed different SF and QoSL trajectories. We recommend that health care professionals, when discussing sexuality, realize that SF and QoSL are no interchangeable terms and should, therefore, be discussed as two separate entities. In addition, it is favored that clinicians focus not only on biological predictors of SF and QoSL, but obtain a broader perspective in which they also pay attention to psychosocial factors that may impair SF and QoSL. More in depth research on interdependence between patients and partners, biopsychosocial predictors of partners' SF and QoSL, and gender effects is needed.

Transanal minimally invasive surgery: initial experience and short-term functional results.

BACKGROUND: Currently, the preferred method for local excision of rectal polyps is transanal endoscopic microsurgery, avoiding rectal resection. Transanal minimally invasive surgery is a relatively new technique using a disposable port in combination with conventional laparoscopic instruments. This method is less expensive as compared with transanal endoscopic microsurgery, relatively easy to learn, and available. Despite wide adoption of transanal minimally invasive surgery, to date only a few series on the implementation and use of this technique are reported, and detailed information on the effect of transanal minimally invasive surgery on fecal continence is not available. OBJECTIVE: The purpose of this work was to prospectively assess the functional outcome after transanal minimally invasive surgery using the Fecal Incontinence Severity Index preoperatively and postoperatively. DESIGN: This was a prospective cohort study. SETTINGS: The study was conducted at a large teaching hospital. PATIENTS: Patients included those who underwent transanal minimally invasive surgery between October 2011 and September 2013. INTERVENTIONS: Transanal minimally invasive surgery was studied. MAIN OUTCOME MEASURES: We measured postoperative surgical and functional results. RESULTS: A total of 37 patients underwent transanal minimally invasive surgery during our study period. Short-term morbidity rate was 14%, and positive resection margins were reported in 6 cases (16%); in 1 of these patients, a local recurrence was observed. Overall, there was a significant decline in preoperative and postoperative Fecal Incontinence Severity Index scores (p = 0.02), indicating an improvement in anorectal function after transanal minimally invasive surgery for patients with impaired preoperative continence. Seventeen patients (49%) had impaired continence before transanal minimally invasive surgery (mean Fecal Incontinence Severity Index score = 21). Continence improved in 15 (88%) of these patients after surgery; no change was observed in 1 patient (6%), and continence further decreased in another. In addition, 18 patients (51%) had normal preoperative continence (Fecal Incontinence Severity Index score = 0), of which 83% had no change in functionality, and continence decreased in 3. LIMITATIONS: No quality of life was measured. CONCLUSIONS: Short-term functional results of transanal minimally invasive surgery for rectal polyps are excellent and comparable to functional results using the dedicated transanal endoscopic microsurgery equipment. More research on outcome after transanal minimally invasive surgery is needed to assess morbidity rates and oncologic clearance.

Comparison between local ablative therapy and chemotherapy for non-resectable colorectal liver metastases: a prospective study.

BACKGROUND: There is a growing interest for the use of local ablative techniques in patients with non-resectable colorectal liver metastases. Evidence on the efficacy over systemic chemotherapy is, however, extremely weak. In this prospective study we aim to assess the additional benefits of local tumour ablation. METHODS: A consecutive series of 201 colorectal cancer patients, without extrahepatic disease, that underwent laparotomy for surgical treatment of liver metastases, were prospectively followed for survival and HRQoL. At laparotomy three groups were identified: patients in whom radical resection of metastases proved feasible, patients in whom resection was not feasible and received local ablative therapy, and patients in whom resection or local ablation was not feasible for technical reasons and who received systemic chemotherapy. FINDINGS: Patients in the chemotherapy and in local ablation group were comparable for all prognostic variables tested. For the local ablation group overall survival at 2 and 5 years was 56 and 27%, respectively (median 31 months, n = 45), for the chemotherapy group 51 and 15%, respectively (median 26 months, n = 39) (P = 0.252). After resection these figures were 83 and 51%, respectively (median 61 months, n = 117) (P < 0.001). The median DFS after local ablation was 9 months, HRQoL was restored within 3 months. Patients after local ablation gained far more QALY's (317) than in the chemotherapy group (165) (P < 0.001). INTERPRETATION: Although overall survival did not reached statistical significance, the median DFS of 9 months suggests a beneficial effect of local tumour ablation for non-resectable colorectal liver metastases. Moreover, compared with systemic chemotherapy more QALY's were gained after local ablative therapy.

Responsiveness of the generic EQ-5D summary measure compared to the disease-specific EORTC QLQ C-30.

INTRODUCTION: We investigated whether the sensitivity of the generic health-related quality of life (HRQoL) EQ-5D summary measure (or index) to detect changes over time in a clinical setting is comparable with that of a disease-specific HRQoL questionnaire. METHODS: Patients with liver metastases (n = 75) filled out the five domains of the EQ-5D self-classifier, the EQ VAS, and the EORTC QLQ C-30 (a disease-specific (cancer) HRQoL questionnaire). The HRQoL instruments were completed before intervention, and 1/2 month and 3 and 6 months after intervention. Three analyses were performed. First, the EQ-5D index (based on self-classification) was compared to the EQ VAS. Second, the EQ-5D domains were compared to corresponding EORTC QLQ C-30 scales. Third, EQ-5D index and EQ VAS were compared with the EORTC QLQ C-30 global health-status scale. Effect size was chosen as the metric of responsiveness. RESULTS: The EQ-5D index was slightly less responsive than the EQ VAS. Overall, the responsiveness of the EQ-SD index and EQ VAS was equal to the EORTC QLQ C-30 global health-status scale. CONCLUSION: Despite its generic principle and the apparent crudeness of its framework, the responsiveness of the EQ-5D proved to be comparable to that of a disease-specific HRQoL questionnaire in this specific clinical setting.