Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (FALCON): an international multicentre randomized controlled trial.

AIM: To assess the added value of Near InfraRed Fluorescence (NIRF) imaging during laparoscopic cholecystectomy. METHODS: This international multicentre randomized controlled trial included participants with an indication for elective laparoscopic cholecystectomy. Participants were randomised into a NIRF imaging assisted laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. Primary end point was time to 'Critical View of Safety' (CVS). The follow-up period of this study was 90 postoperative days. An expert panel analysed the video recordings after surgery to confirm designated surgical time points. RESULTS: A total of 294 patients were included, of which 143 were randomized in the NIRF-LC and 151 in the CLC group. Baseline characteristics were equally distributed. Time to CVS was on average 19 min and 14 s for the NIRF-LC group and 23 min and 9 s for the CLC group (p 0.032). Time to identification of the CD was 6 min and 47 s and 13 min for NIRF-LC and CLC respectively (p < 0.001). Transition of the CD in the gallbladder was identified after an average of 9 min and 39 s with NIRF-LC, compared to 18 min and 7 s with CLC (p < 0.001). No difference in postoperative length of hospital stay nor occurrence of postoperative complications was found. ICG related complications were limited to one patient who developed a rash after injection of ICG. CONCLUSION: Use of NIRF imaging in laparoscopic cholecystectomy provides earlier identification of relevant extrahepatic biliary anatomy: earlier achievement of CVS, cystic duct visualisation and visualisation of both cystic duct and cystic artery transition into the gallbladder.

Assessing the learning curve of robot-assisted total mesorectal excision: a multicenter study considering procedural safety, pathological safety, and efficiency.

PURPOSE: Evidence regarding the learning curve of robot-assisted total mesorectal excision is scarce and of low quality. Case-mix is mostly not taken into account, and learning curves are based on operative time, while preferably clinical outcomes and literature-based limits should be used. Therefore, this study aims to assess the learning curve of robot-assisted total mesorectal excision. METHODS: A retrospective study was performed in four Dutch centers. The primary aim was to assess the safety of the individual and institutional learning curves using a RA-CUSUM analysis based on intraoperative complications, major postoperative complications, and compound pathological outcome (positive circumferential margin or incomplete TME specimen). The learning curve for efficiency was assessed using a LC-CUSUM analysis for operative time. Outcomes of patients before and after the learning curve were compared. RESULTS: In this study, seven participating surgeons performed robot-assisted total mesorectal excisions in 531 patients. Learning curves for intraoperative complications, postoperative complications, and compound pathological outcome did not exceed predefined literature-based limits. The LC-CUSUM for operative time showed lengths of the learning curve ranging from 12 to 35 cases. Intraoperative, postoperative, and pathological outcomes did not differ between patients operated during and after the learning curve. CONCLUSION: The learning curve of robot-assisted total mesorectal excision based on intraoperative complications, postoperative complications, and compound pathological outcome did not exceed predefined limits and is therefore suggested to be safe. Using operative time as a surrogate for efficiency, the learning curve is estimated to be between 12 and 35 procedures.

Local recurrence of robot-assisted total mesorectal excision: a multicentre cohort study evaluating the initial cases.

PURPOSE: Evidence regarding local recurrence rates in the initial cases after implementation of robot-assisted total mesorectal excision is limited. This study aims to describe local recurrence rates in four large Dutch centres during their initial cases. METHODS: Four large Dutch centres started with the implementation of robot-assisted total mesorectal excision in respectively 2011, 2012, 2015, and 2016. Patients who underwent robot-assisted total mesorectal excision with curative intent in an elective setting for rectal carcinoma defined according to the sigmoid take-off were included. Overall survival, disease-free survival, systemic recurrence, and local recurrence were assessed at 3 years postoperatively. Subsequently, outcomes between the initial 10 cases, cases 11-40, and the subsequent cases per surgeon were compared using Cox regression analysis. RESULTS: In total, 531 patients were included. Median follow-up time was 32 months (IQR: 19-50]. During the initial 10 cases, overall survival was 89.5%, disease-free survival was 73.1%, and local recurrence was 4.9%. During cases 11-40, this was 87.7%, 74.1%, and 6.6% respectively. Multivariable Cox regression did not reveal differences in local recurrence between the different case groups. CONCLUSION: Local recurrence rate during the initial phases of implantation of robot-assisted total mesorectal procedures is low. Implementation of the robot-assisted technique can safely be performed, without additional cases of local recurrence during the initial cases, if performed by surgeons experienced in laparoscopic rectal cancer surgery.

Effectiveness of a Tailored Work-Related Support Intervention for Patients Diagnosed with Gastrointestinal Cancer: A Multicenter Randomized Controlled Trial.

Purpose The aim of this research was to study the effectiveness on return to work (RTW) of an early tailored work-related support intervention in patients diagnosed with curative gastrointestinal cancer. Methods A multicenter randomized controlled trial was undertaken, in which patients were assigned randomly to the intervention or the control group (usual care). The intervention encompassed three psychosocial work-related support meetings, starting before treatment. Five self-reported questionnaires were sent over twelve months of follow-up. Primary outcome was days until RTW (fulltime or partial) and secondary outcomes included work status, quality of life, work ability, and work limitations. Descriptive analysis, Kaplan-Meier analysis, relative risk ratio and linear mixed models were applied. Results Participants (N = 88) had a mean age of 55 years; 67% were male and the most common cancer type was colon cancer (66%). Of the participants, 42 were randomized to the intervention group. The median time from sick leave until RTW was 233 days (range 187-279 days) for the control group, versus 190 days (range 139-240 days) for the intervention group (log-rank p = 0.37). The RTW rate at twelve months after baseline was 83.3% for the intervention group and 73.5% for the control group. Work limitations did statistically differ between the groups over time (p = 0.01), but quality of life and work ability did not. Conclusion Patients in the intervention group seem to take fewer days to RTW, albeit not to a statistically significant extent.Trial registration Trial NL4920 (NTR5022) (Dutch Trial Register https://www.trialregister.nl ).

The effect of the number of active electrode poles during tined lead placement on long-term efficacy of sacral neuromodulation in patients with faecal incontinence.

AIM: There is an ongoing debate as to whether or not the efficacy of sacral neuromodulation (SNM) is optimized by maximizing the total number of active electrode poles (AEPs) during lead placement because there are more programming options. However, this is at the cost of increased operating time. The aims of this study were to establish if a higher number of AEPs improves SNM efficacy during the trial period and after permanent implantable pulse generator (IPG) placement and if there is there a correlation between number of AEPs and battery life of the first placed IPG. METHOD: This was a single centre retrospective cohort study of new patients with faecal incontinence who underwent SNM between 2000 and 2018. Exclusion criteria were sphincter defect > 30%, rectocele/enterocele Grade 3 or higher and incomplete records. RESULTS: In all, 288/456 (63%) patients (women 91%; mean age 58.5 ± 11.7 years) were eligible for analysis. The number of AEPs during lead placement was two (n = 42, 14.5%), three (n = 82, 28.5%) and four (n = 164, 57%). There was no association between the number of AEPs during tined lead placement and long-term efficacy. Neither the success rate of the trial phase nor the battery life after first placed IPG was influenced by the number of AEPs. CONCLUSION: In this study, the number of AEPs does not seem to influence long-term efficacy of SNM success rate during the trial phase or the battery life of the first placed IPG. However, we also suggest that at the very least there should be two AEPs at lead placement.

Outcomes of completion total mesorectal excision are not compromised by prior transanal minimally invasive surgery.

AIM: Transanal minimally invasive surgery (TAMIS) is used increasingly often as an organ-preserving treatment for early rectal cancer. If final pathology reveals unfavourable histological prognostic features, completion total mesorectal excision (cTME) is recommended. This study is the first to investigate the results of cTME after TAMIS. METHOD: Data were retrieved from the prospective database of the Elisabeth-TweeSteden Hospital. Completion TME patients were case matched with a control group of patients undergoing primary TME (pTME). Primary and secondary outcomes were surgical outcomes and oncological outcomes, respectively. RESULTS: From 2011 to 2017, 20 patients underwent cTME and were compared with 40 patients undergoing pTME. There were no significant differences in operating time (238 min vs 226 min, P = 0.53), blood loss (137 ml vs. 158 ml, P = 0.88) or complications (45% vs 55%, P = 0.07) between both groups. There was no 90-day mortality in the cTME group. The mesorectal fascia was incomplete in three patients (15%) in the cTME group compared with no breaches in the pTME group (P = 0.083). There were no local recurrences in either group. In three patients (15%), distant metastases were detected after cTME compared with one patient (2.5%) in the pTME group (P = 0.069). After cTME patients had a 1- and 5-year disease-free survival of 85% compared with 97.5% for the pTME group (P = 0.062). CONCLUSION: Completion TME surgery after TAMIS is not associated with increased peri- or postoperative morbidity or mortality compared with pTME surgery. After cTME surgery patients have a similar disease-free and overall survival when compared with patients undergoing pTME.

Meta-analysis of postoperative pain using non-sutured or sutured single-layer open mesh repair for inguinal hernia.

Background: Chronic postoperative pain occurs in up to 21·7 per cent of patients undergoing open inguinal hernia repair. Several mesh fixation techniques using glue or self-gripping meshes have been developed to reduce postoperative pain. The aim of this meta-analysis was to evaluate RCTs comparing adhesional/self-gripping and sutured single-layer open mesh fixations in the repair of inguinal herniation, with postoperative pain as endpoint. Methods: PubMed, Embase and Cochrane CENTRAL databases were searched systematically for RCTs according to the PRISMA guidelines; the study was registered at PROSPERO (CRD42017056373). Different fixation methods were analysed. The primary outcome, chronic pain, was defined as a postoperative visual analogue scale (VAS) score of at least 3 at 12 months. Secondary outcomes were mean VAS score at 1 week and at 1 month after surgery. Results: Twenty-three studies including 5190 patients were included in the meta-analysis. Adhesional (self-adhering or glued) or self-gripping fixation methods were associated with a significantly lower VAS score at 1 week (mean difference -0·49, 95 per cent c.i. -0·81 to -0·17; P = 0·003) and at 1 month (mean difference -0·31, -0·58 to -0·04; P = 0·02) after surgery than suture fixation, but the incidence of chronic pain after 12 months was similar in the two groups (odds ratio 0·70, 95 per cent c.i. 0·30 to 1·66). Differences in recurrences and complications between groups did not reach statistical significance. Conclusion: There was no difference in the incidence of chronic pain 12 months after different mesh repair fixation techniques despite significant reductions in short-term postoperative pain favouring a non-sutured technique. There were no differences in recurrence rates or in rates of other complications at 1 year.

European Society of Coloproctology Core Outcome Set for haemorrhoidal disease: an international Delphi study among healthcare professionals.

AIM: There is considerable heterogeneity in outcomes in studies reporting on the treatment of haemorrhoidal disease (HD). The aim of this study was to develop a Core Outcome Set (COS) for HD in cooperation with the European Society of Coloproctology. METHOD: A Delphi study was performed according to the Outcome Measures in Rheumatology (OMERACT) methodology. In total 38 healthcare professionals and 30 patients were invited to the panel. Previously, 10 outcome domains and 59 outcomes were identified through a systematic literature review. In this study, these domains and outcomes were formed into one questionnaire for healthcare professionals and a separate questionnaire for patients. Sequential questionnaire rounds prioritizing the domains and outcomes were conducted. Panel members were asked to rate the appropriateness of each domain and outcome on a nine-point Likert scale. During a face-to-face meeting, healthcare professionals agreed on the primary and secondary end-points of the COS for HD. Finally, a short survey was sent to the healthcare professionals in order to reach consensus on how the chosen end-points should be assessed and at which time points. RESULTS: The response rate in questionnaire round 1 for healthcare professionals was 44.7% (n = 17). Sixteen out of 17 healthcare professionals also completed the questionnaire in round 2. The response rate for the patient questionnaire was 60% (n = 18). Seventeen healthcare professionals participated in the face-to-face meeting. The questionnaire rounds did not result in a clear-cut selection of primary and secondary end-points. Most domains and outcomes were considered important, and only three outcomes were excluded. During the face-to-face meeting, agreement was reached to select the domain 'symptoms' as primary end-point, and 'complications', 'recurrence' and 'patient satisfaction' as secondary end-points in the COS for HD. Furthermore, consensus was reached that the domain 'symptoms' should be a patient reported outcome measure and should include the outcomes 'pain' and 'prolapse', 'itching', 'soiling' and 'blood loss'. The domain 'complications' should include the outcomes 'incontinence', 'abscess', 'urinary retention', 'anal stenosis' and 'fistula'. Consensus was reached to use 'reappearance of initial symptoms' as reported by the patient to define recurrence. During an additional short survey, consensus was reached that 'incontinence' should be assessed by the Wexner Fecal Incontinence Score, 'abscess' by physical examination, 'urinary retention' by ultrasonography, 'anal stenosis' by physical examination, and 'fistula' by physical examination and MR imaging if inconclusive. During follow-up, the outcome 'symptoms' should be assessed at baseline, 7 days, 6 weeks and 1 year post-procedure. The outcomes 'abscess' and 'urinary retention' should be assessed 7 days post-procedure and 'incontinence', 'anal stenosis' and 'fistula' 1 year post-procedure. CONCLUSIONS: We developed the first European Society of Coloproctology COS for HD based on an international Delphi study among healthcare professionals. The next step is to incorporate the patients' perspective in the COS. Use of this COS may improve the quality and uniformity of future research and enhance the analysis of evidence.

A decade of litigation regarding surgical informed consent in the Netherlands.

OBJECTIVE: An inadequate surgical informed consent process (SIC) may result in a medical malpractice claim or medical disciplinary board (MDB) complaint. Aim of this study was to analyse characteristics of a decade of malpractice claims and MDB decisions regarding SIC in the Netherlands. METHODS: A retrospective analysis of malpractice claims and MDB decisions concerning SIC disputes in four major surgical specialties was conducted based on company data from the largest medical malpractice insurance company and two public available online MDB databases. RESULTS: A total of 11376 malpractice claims and 661 MDB complaints were filed between 2004-2013 and 676(6%) of these claims and 69(10%) of these complaints involved an alleged deficient SIC process. A random sample of 245(37%) claims and all MDB decisions were analysed. Reasons for filing a claim or complaint were insufficient counselling or recording of SIC elements. In 20% of lawsuits and 25% of claims the case resulted in favour of the complainant. CONCLUSION: A substantial portion of malpractice claims and MDB decisions is related to a deficient SIC process. PRACTICE IMPLICATIONS: Focusing on crucial SIC elements for patients may improve satisfaction and expectations and result in a lower risk for malpractice claims and MDB complaints.

Evaluation of a novel dye for near-infrared fluorescence delineation of the ureters during laparoscopy.

BACKGROUND: Iatrogenic ureteric injury remains a risk in laparoscopic pelvic procedures. Near-infrared fluorescence (NIRF) imaging is a promising new technique for enhanced intraoperative visualization of anatomical structures that could improve the safety of laparoscopic surgery. A new dye, IRDye® 800-BK, has been developed for intraoperative visualization of the ureters using NIRF. The present study was a first evaluation of the performance of IRDye® 800-BK for ureteric imaging during NIRF laparoscopy. METHODS: This study consisted of three parts: real-time in vivo NIRF imaging using IRDye® 800-BK in pigs during laparoscopic surgery, ex vivo NIRF imaging of freshly explanted pig ureters and ex vivo NIRF imaging of explanted human ureters. RESULTS: In all animals, both left and right ureters were visualized throughout the laparoscopic procedure for 120 min, with the best results at a dose of 0·15 mg dye per kg bodyweight. NIRF imaging was successful in all human and porcine ureters studied, with a range of dye concentrations. CONCLUSION: NIRF imaging of the ureters using IRDye® 800-BK was used successfully both in vivo in a porcine model, and ex vivo in porcine and human ureters.

Long-term outcomes of a Malone antegrade continence enema (MACE) for the treatment of fecal incontinence or constipation in adults.

PURPOSE: The aim of the study was to assess the long-term outcome of a Malone antegrade continence enema (MACE) procedure for fecal incontinence or constipation in adults. METHODS: This retrospective single-center study assessed the long-term outcome and quality of life (QoL) of patients who underwent a MACE procedure between 2005 and 2014 at the Maastricht University Medical Centre. Success rate was quantified by using Malone's continence scale. Quality of life was assessed by validated questionnaires covering general quality of life (SF-36 and Karnofsky scale), current pain level (visual analog scale), fecal incontinence (Vaizey incontinence survey), or constipation (Cleveland Clinic Constipation Score). RESULTS: Based on patients' records, 22 out of 30 patients (73%; 95% CI 54-87%) were still using their MACE. Mean follow-up was 43 months (SD 25.9) since time of surgery. According to the Malone continence scale, the overall success rate was 37% (95% CI 20.0-53.3). Nine patients developed a postoperative complication. Eighteen out of 22 patients (13 with constipation and 5 with fecal incontinence) returned the QoL questionnaires (82% response rate). Long-term quality of life of patients with a MACE did not differ from the general Dutch population. CONCLUSIONS: In our cohort of patients with fecal incontinence or constipation, MACE resulted in a disappointed overall success rate of 37%. However, it may be indicated in patients who do not prefer more invasive surgical procedures or a definite stoma. The success and morbidity rate should be thoroughly discussed with the patients preoperatively.

Towards a core outcome set for hemorrhoidal disease-a systematic review of outcomes reported in literature.

PURPOSE: Previously published literature regarding treatment of hemorrhoidal disease (HD) revealed a lack of uniform defined outcomes. These differences between outcomes among studies limit transparency and lead to incomparability of results. The aim of this study was to systematically list the types of outcomes used in HD studies. This list will be used to develop a core outcome set. METHODS: We searched Medline (Pubmed), Embase (OVID), and Cochrane for interventional studies for adult patients with HD. Two authors independently identified and reviewed eligible studies. This resulted in a list of outcomes reported by each clinical trial. All outcomes were categorized using the conceptual framework OMERACT filter 2.0. RESULTS: A total of 34 randomized controlled trials and prospective observational studies were included in this study. A total of 59 different types of outcomes were identified. On average, 5.8 different outcomes (range 2-8) were used per study. The outcomes were structured into three core areas and10 ten domains. The most commonly reported core area was pathophysiological manifestations including the domain symptoms, complications, and recurrence. The most frequently reported outcomes were pain (91%), blood loss (94%), prolapse (71%), and incontinence (56%). There was a high variation in definitions of the common outcomes. And often there was no definition at all. CONCLUSION: This study shows a substantial heterogeneity in the types of outcomes in HD studies. We provided an overview of the types of outcomes reported in HD studies and identified a list of potentially relevant outcomes required for the development of a COS.

Long-term outcome of intractable constipation treated by sacral neuromodulation: a comparison between children and adults.

AIM: Sacral neuromodulation (SNM) is a minimally invasive therapy for functional constipation (FC) and is most often used to treat adults. Recent studies suggest that SNM may also beneficial in children. However, comparative data regarding preferred age of SNM for FC are lacking. Therefore, long-term results of SNM for FC were compared between children and adults. METHOD: All patients treated with SNM for FC between 2004 and 2015 were evaluated. Outcomes of children (age 10-18 years) were compared with those for adults (≥ 18 years). The primary end-point was a defaecation frequency of three or more times per week, which is consistent with the ROME-III criteria. Secondary outcomes were quality of life (QoL; SF-36) and the Cleveland Clinic Constipation Score. RESULTS: One hundred and eighty patients (45 children, 135 adults) were eligible for SNM. The mean age was 15.8 (children) and 41.4 years (adults). One hundred and twenty-six patients received permanent SNM (38 children, 88 adults). Mean follow-up was 47 months in both groups. Defaecation frequency increased in both groups after SNM compared with baseline. Defaecation frequency in adults was higher than in children. The increased defaecation frequency was maintained during the entire follow-up period in both groups. QoL of children was impaired compared with the Dutch population with regard to bodily pain, general health and vitality. Adults had worse QoL with regard to physical functioning, bodily pain, general health, vitality and social functioning compared with the Dutch population. QoL of children did not differ from adults. CONCLUSION: Sacral neuromodulation (SNM) should be considered in children (< 18 years) with FC. However, the indication of SNM for FC remains debatable considering the limited improvements and high costs.

Behavioral outcomes of a novel, pelvic nerve damage rat model of fecal incontinence.

BACKGROUND: Fecal incontinence (FI) has a multifactorial pathophysiology with a severe social impact. The most common cause for FI is pudendal nerve damage, which mostly occurs in women during or after labor. A better understanding of the pathophysiology is required to optimize treatment of FI. In this study, we evaluate the use of a novel pelvic nerve damage rat model of FI. METHODS: This new model simulates the forces on the pelvic floor during labor by prolonged transvaginal, retro-uterine intrapelvic balloon distention in female rats. Number of fecal pellets produced per day and defecation pattern was compared between the experimental and control group for 2 weeks. The cages of the rats were divided in food, nesting and latrine areas to evaluate changes in defecation pattern. The FI Index (FII) was calculated to assess the ratio of fecal pellets between the non-latrine areas and the total number of pellets. A higher score represents more random distribution of feces outside the latrine area. RESULTS: Total number of fecal pellets was higher in the experimental group as compared with the controls. In both groups most fecal pellets were deposited in the nesting area, which is closest to the food area. The experimental group deposited more fecal pellets in the latrine area and had a lower FII indicating less random distribution of feces outside the latrine area. CONCLUSION: Transvaginal, retro-uterine intrapelvic balloon distention is a safe and feasible animal model simulating the human physiologic impact of labor by downwards pressure on the pelvic floor.

Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: the CLEAN study.

INTRODUCTION: Non-healing of anastomotic leakage can be observed in up to 50% after total mesorectal excision for rectal cancer. This study investigates the efficacy of early transanal closure of anastomotic leakage after pre-treatment with the Endosponge® therapy. METHODS: In this prospective, multicentre, feasibility study, transanal suturing of the anastomotic defect was performed after vacuum-assisted cleaning of the presacral cavity. Primary outcome was the proportion of patients with a healed anastomosis at 6 months after transanal closure. Secondary, healing at last follow-up, continuity, direct medical costs, functionality and quality of life were analysed. RESULTS: Between July 2013 and July 2015, 30 rectal cancer patients with a leaking low colorectal anastomosis were included, of whom 22 underwent neoadjuvant radiotherapy. Median follow-up was 14 (7-29) months. At 6 months, the anastomosis had healed in 16 (53%) patients. At last follow-up, anastomotic integrity was found in 21 (70%) and continuity was restored in 20 (67%) patients. Non-healing at 12 months was observed in 10/29 (34%) patients overall, and in 3/14 (21%) when therapy started within three weeks following the index operation. Major LARS was reported in 12/15 (80%) patients. The direct medical costs were €8933 (95% CI 7268-10,707) per patient. CONCLUSION: Vacuum-assisted early transanal closure of a leaking anastomosis after total mesorectal excision with 73% preoperative radiotherapy showed that acceptable anastomotic healing rates and stoma reversal rates can be achieved. Early diagnosis and start of treatment seems crucial.

The association between performance parameters of physical fitness and postoperative outcomes in patients undergoing colorectal surgery: An evaluation of care data.

BACKGROUND: Preoperative cardiorespiratory fitness, as measured by cardiopulmonary testing or estimated using the less sophisticated incremental shuttle walk test, timed up-and-go test or stair climb test is known to be associated with postoperative outcome. This study aimed to evaluate whether parameters of physical fitness are associated with postoperative outcome in patients with colorectal cancer scheduled for elective resection. PATIENTS AND METHODS: Perioperative data of patients who underwent colorectal resection at Maastricht University Medical Center were retrospectively analyzed. Preoperative variables (e.g., age, body mass index, comorbidities, physical fitness, tumour characteristics, neoadjuvant treatment, American Society of Anesthesiologists score, level of perceived fatigue and nutritional status) were compared with postoperative outcomes. RESULTS: Out of 80 consecutive cases, 75 (93.8%) were available for analysis (57.3% male, median ± interquartile range age 69.2 ± 11.7 years). A higher Charlson comorbidity index (odds ratio (OR) of 1.604, 95% confidence interval (CI) 1.120-2.296), worse functional exercise capacity (in meters, OR of 0.995, 95% CI 0.991-1.000), a lower physical activity level (in min/day, OR of 0.994, 95% CI 0.988-1.000), and a higher level of perceived fatigue (OR of 1.047, 95% CI 1.016-1.078), were associated with a slower time to recovery of physical functioning. A better functional exercise capacity was associated with a lower OR (OR of 0.995, 95% CI 0.991-1.000) for non-surgical complications. CONCLUSION: There is an association between preoperative parameters and postoperative outcomes in patients with colorectal cancer scheduled for resection. Patients benefit from an optimal preoperative physical fitness level. Specific interventions can target this physical fitness level.

[Changes in the treatment of Crohn's disease: fewer hospitalizations, less surgery, and reduced glucocorticoid use]. / Veranderingen in de behandeling van ziekte van Crohn.

OBJECTIVE: To study changes in treatment and disease course in patients with Crohn's disease (CD) in the South Limburg region of the Netherlands between 1991 and 2014. DESIGN: Population-based cohort study. METHODS: All 1162 CD patients in the 'IBD South Limburg cohort' were divided across three subcohorts on the basis of year of diagnosis: 1991-1998 (N = 316), 1999-2005 (N = 387) and 2006-2011 (N = 459). We compared the risk of hospitalization, bowel resection and the development of strictures and/or fistulas across the subcohorts. We also compared cumulative corticosteroid use and the relationship between the outcome measures and maintenance medication. RESULTS: In the period 1991-2014 there was an increase in the number of patients treated within 5 years with immunomodulators from 30.6% to 70.8%. For treatment with biologicals there was an increase from 3.1% to 41.2%. In parallel, the risk of hospitalization decreased from 65.9% to 44.2% and the risk of bowel resection decreased from 42.9% to 17.4%. The risk of developing strictures or fistulas remained stable (21.2%). There was no significant association between the outcome measures and the use of immunomodulators or biologicals. Furthermore, corticosteroid use decreased over time; this was linked to use of immunomodulators and biologicals. CONCLUSION: Treatment of Crohn's disease has changed over the past two decades, and the disease course has improved. We found no association between changes in maintenance medication and disease course.

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study.

PURPOSE: Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease. METHODS: A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS. DISCUSSION: Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.