Determinants of Physical Activity among Patients with Colorectal Cancer: From Diagnosis to 5 Years after Diagnosis.

INTRODUCTION: Physical activity (PA) is associated with higher quality of life and probably better prognosis among colorectal cancer (CRC) patients. This study focuses on determinants of PA among CRC patients from diagnosis until 5 yr postdiagnosis. METHODS: Sociodemographic and disease-related factors of participants of two large CRC cohort studies were combined. Moderate-to-vigorous PA during sport and leisure time (MVPA-SL) was measured at diagnosis (T0) and 6, 12, 24, and 60 months (T6 to T60) postdiagnosis, using the SQUASH questionnaire. Mixed-effects models were performed to identify sociodemographic and disease-related determinants of MVPA-SL, separately for stage I-III colon (CC), stage I-III rectal cancer (RC), and stage IV CRC (T0 and T6 only). Associations were defined as consistently present when significant at ≥4 timepoints for the stage I-III subsets. MVPA-SL levels were compared with an age- and sex-matched sample of the general Dutch population. RESULTS: In total, 2905 CC, 1459 RC and 436 stage IV CRC patients were included. Patients with higher fatigue scores, and women compared with men had consistently lower MVPA-SL levels over time, regardless of tumor type and stage. At T6, having a stoma was significantly associated with lower MVPA-SL among stage I-III RC patients. Systemic therapy and radiotherapy were not significantly associated with MVPA-SL changes at T6. Compared with the general population, MVPA-SL levels of CRC patients were lower at all timepoints, most notably at T6. CONCLUSIONS: Female sex and higher fatigue scores were consistent determinants of lower MVPA-SL levels among all CRC patients, and MVPA-SL levels were lowest at 6 months postdiagnosis. Our results can inform the design of intervention studies aimed at improving PA, and guide healthcare professionals in optimizing individualized support.

Functional Bowel Complaints and the Impact on Quality of Life After Colorectal Cancer Surgery in the Elderly.

BACKGROUND: The Low Anterior Resection Syndrome (LARS) is commonly reported after colorectal cancer surgery and significantly impairs quality of life. The prevalence and impact of LARS in the elderly after rectal cancer as well as colon cancer surgery is unclear. We aimed to describe the prevalence of LARS complaints and the impact on quality of life in the elderly after colorectal cancer surgery. MATERIALS AND METHODS: Patients were included from seven Dutch hospitals if they were at least one year after they underwent colorectal cancer surgery between 2008 and 2015. Functional bowel complaints were assessed by the LARS score. Quality of life was assessed by the EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires. Outcomes in patients ≥70 years were compared to a reference group of patients <70 years. RESULTS: In total 440 rectal cancer and 1183 colon cancer patients were eligible for analyses, of whom 133 (30.2%) rectal and 536 (45.3%) colon cancer patients were ≥70 years. Major LARS was reported by 40.6% of rectal cancer and 22.2% of colon cancer patients ≥70 years. In comparison, patients <70 years reported major LARS in 57.3% after rectal cancer surgery (p=0.001) and in 20.4% after colon cancer surgery (p=0.41). Age ≥70 years was independently associated with reduced rates of major LARS after rectal cancer surgery (OR 0.63, p=0.04). Patients with major LARS reported significantly impaired quality of life on almost all domains. CONCLUSION: Elderly should not be withheld a restorative colorectal cancer resection based on age alone. However, a substantial part of the elderly colorectal cancer patients develops major LARS after surgery, which often severely impairs quality of life. Since elderly frequently consider quality of life and functional outcomes as one of the most important outcomes after treatment, major LARS and its impact on quality of life should be incorporated in the decision-making process.

Physical Activity Is Associated with Improved Overall Survival among Patients with Metastatic Colorectal Cancer.

Regular physical activity (PA) is associated with improved overall survival (OS) in stage I-III colorectal cancer (CRC) patients. This association is less defined in patients with metastatic CRC (mCRC). We therefore conducted a study in mCRC patients participating in the Prospective Dutch Colorectal Cancer cohort. PA was assessed with the validated SQUASH questionnaire, filled-in within a maximum of 60 days after diagnosis of mCRC. PA was quantified by calculating Metabolic Equivalent Task (MET) hours per week. American College of Sports and Medicine (ACSM) PA guideline adherence, tertiles of moderate to vigorous PA (MVPA), and sport and leisure time MVPA (MVPA-SL) were assessed as well. Vital status was obtained from the municipal population registry. Cox proportional-hazards models were used to study the association between PA determinants and all-cause mortality adjusted for prognostic patient and treatment-related factors. In total, 293 mCRC patients (mean age 62.9 ± 10.6 years, 67% male) were included in the analysis. Compared to low levels, moderate and high levels of MET-hours were significantly associated with longer OS (fully adjusted hazard ratios: 0.491, (95% CI 0.299-0.807, p value = 0.005) and 0.485 (95% CI 0.303-0.778, p value = 0.003), respectively), as were high levels of MVPA (0.476 (95% CI 0.278-0.816, p value = 0.007)) and MVPA-SL (0.389 (95% CI 0.224-0.677, p value < 0.001)), and adherence to ACSM PA guidelines compared to non-adherence (0.629 (95% CI 0.412-0.961, p value = 0.032)). The present study provides evidence that higher PA levels at diagnosis of mCRC are associated with longer OS.

Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicenter, Observational Study (PERFECT - Trial).

OBJECTIVE: To determine the prevalence of FD and IBS in patients eligible for cholecystectomy and to investigate the association between presence of FD/ IBS and resolution of biliary colic and a pain-free state. SUMMARY BACKGROUND DATA: More than 30% of patients with symptomatic cholecystolithiasis reports persisting pain postcholecystectomy. Coexistence of FD/IBS may contribute to this unsatisfactory outcome. METHODS: We conducted a multicenter, prospective, observational study (PERFECT-trial). Patients ≥18 years with abdominal pain and gallstones were included at 5 surgical outpatient clinics between 01/2018 and 04/2019. Follow-up was 6 months. Primary outcomes were prevalence of FD/IBS, and the difference between resolution of biliary colic and pain-free state in patients with and without FD/IBS. FD/IBS was defined by the Rome IV criteria, biliary colic by the Rome III criteria, and pain-free by an Izbicki Pain Score ≤10 and visual analogue scale ≤4. RESULTS: We included 401 patients with abdominal pain and gallstones (assumed eligible for cholecystectomy), mean age 52 years, 76% females. Of these, 34.9% fulfilled criteria for FD/IBS. 64.1% fulfilled criteria for biliary colic and 74.9% underwent cholecystectomy, with similar operation rates in patients with and without FD/IBS. Postcholecystectomy, 6.1% of patients fulfilled criteria for biliary colic, with no significant difference between those with and without FD/IBS at baseline (4.9% vs 8.6%, P = 0.22). Of all patients, 56.8% was pain-free after cholecystectomy, 40.7% of FD/IBS-group vs 64.4% of no FD/IBS-group, P < 0.001. CONCLUSIONS: One third of patients eligible for cholecystectomy fulfil criteria for FD/IBS. Biliary colic is reported by only a few patients postcholecys-tectomy, whereas nonbiliary abdominal pain persists in >40%, particularly in those with FD/IBS precholecystectomy. Clinicians should take these symptom-dependent outcomes into account in their shared decision-making process. TRIAL REGISTRATION: The Netherlands Trial Register NTR-7307. Registered on 18 June 2018.

Frailty screening by Geriatric-8 and 4-meter gait speed test is feasible and predicts postoperative complications in elderly colorectal cancer patients.

INTRODUCTION: Identification of frail older colorectal cancer patients might help to select those prone to adverse events and may lead to adjustment of treatment plans. However, the prognostic validity of screening for frailty is unknown. METHODS: This retrospective study evaluates colorectal cancer patients ≥70 years who underwent elective surgery between May 2016 and December 2018. The Geriatric-8 (G8) and 4-m gait speed test (4MGST) were used as frailty screening tools. According to hospital guidelines, patients were referred to a geriatrician when screening was indicative for frailty (G8 ≤ 14 and/or 4MGST < 1 m/s). Patients were categorized as fit, vulnerable or frail by comprehensive geriatric assessment (CGA). The clinical implications and prognostic validity of frailty screening and CGA were evaluated. RESULTS: 149 patients were included, of whom 132 (89%) were screened for frailty. Frailty was suspected in 40% of screened patients (n = 53) of whom 89% (n = 47) was referred for CGA. A higher complication rate was seen in patients with G8 ≤ 14 and/or 4MGST < 1 m/s compared to those with G8 > 14 and 4MGST ≥1 m/s (respectively 62% versus 28%,p < 0.001). Pneumonia (21% versus 6%, p = 0.013) and cardiac complications (11% versus 4%, p = 0.093) were more prevalent in patients with G8 ≤ 14 and/or 4MGST < 1 m/s. CGA identified frail patients as a group with a high complication rate of 68%. CONCLUSION: Screening for frailty with subsequent referral for CGA is feasible in older colorectal cancer patients. Our study suggests that screening for frailty by G8 + 4MGST can identify patients with higher risk for postoperative complications.

Quality of Life and Bowel Dysfunction after Transanal Endoscopic Microsurgery for Rectal Cancer: One Third of Patients Experience Major Low Anterior Resection Syndrome.

BACKGROUND/AIMS: The low anterior resection syndrome (LARS) severely affects quality of life (QoL) after rectal cancer surgery. Studies investigating LARS and the effect on QoL after transanal endoscopic microsurgery (TEM) for rectal cancer are scarce. The aim of our study was to assess bowel dysfunction and QoL after TEM. METHODS: Seventy-three -patients who underwent TEM for stage I rectal cancer were included in this single-centre, cross-sectional study Bowel dysfunction was assessed by the LARS-Score, QoL by the -European Organization for the Research and Treatment of Cancer QLQ-C30 and -CR29 questionnaires. RESULTS: Fifty-five respondents (75.3%) could be included for the analyses. The median interval since treatment was 4.3 years, and the median age at the follow-up point was 72 years. "Major LARS" was observed in 29% of patients and "minor LARS" in 26%. Female gender (OR 4.00; 95% CI 1.20-13.36), neo-adjuvant chemoradiotherapy (OR 3.63; 95% CI 1.08-12.17) and specimen thickness in millimetres (OR 1.10 for each mm increase in thickness; 95% CI 1.01-1.20) were associated with the development of major LARS. Patients with major LARS fared worse in most QoL domains. CONCLUSION: This is the first study demonstrating major LARS after TEM treatment for rectal cancer, with a negative effect on QoL, even years after treatment. Our data provides an adequate counselling before TEM in terms of postoperative bowel dysfunction and its effect on QoL.

Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or faecal peritonitis (LADIES): a multicentre, parallel-group, randomised, open-label, superiority trial.

BACKGROUND: Previous studies have suggested that sigmoidectomy with primary anastomosis is superior to Hartmann's procedure. The likelihood of stoma reversal after primary anastomosis has been reported to be higher and reversal seems to be associated with lower morbidity and mortality. Although promising, results from these previous studies remain uncertain because of potential selection bias. Therefore, this study aimed to assess outcomes after Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease) in a randomised trial. METHODS: A multicentre, randomised, open-label, superiority trial was done in eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands. Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid. Patients with Hinchey I or II diverticulitis were not eligible for inclusion. Patients were allocated (1:1) to Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy. Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone. Random and concealed block sizes of two, four, or six were used, and randomisation was stratified by age (<60 and ≥60 years). The primary endpoint was 12-month stoma-free survival. Patients were analysed according to a modified intention-to-treat principle. The trial is registered with the Netherlands Trial Register, number NTR2037, and ClinicalTrials.gov, number NCT01317485. FINDINGS: Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016, 133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease) were randomly assigned to Hartmann's procedure (68 patients) or primary anastomosis (65 patients). Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease). In 17 (27%) of 64 patients assigned to primary anastomosis, no stoma was constructed. 12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001). There were no significant differences in short-term morbidity and mortality after the index procedure for Hartmann's procedure compared with primary anastomosis (morbidity: 29 [44%] of 66 patients vs 25 [39%] of 64, p=0·60; mortality: two [3%] vs four [6%], p=0·44). INTERPRETATION: In haemodynamically stable, immunocompetent patients younger than 85 years, primary anastomosis is preferable to Hartmann's procedure as a treatment for perforated diverticulitis (Hinchey III or Hinchey IV disease). FUNDING: Netherlands Organisation for Health Research and Development.

Internal herniation of the abdominal wall.

A symptomatic arcuate line hernia should be considered in patients with acute lower abdominal complaints. This rare internal herniation is caused by a sharp ending of the posterior aponeurotic sheath of the rectus muscle, rather than the more common gradual delineation, and can cause strangulation or incarceration of abdominal contents.

Mesh OR Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS-Trial): The Complete Two-year Follow-up.

OBJECTIVE: The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complications. Complications such as an extended operation duration, additional use of painkillers, reoperation, infection, seroma, extended wound care, extended hospitalization, and early recurrence were reported according to the Clavien-Dindo grading system. SUMMARY BACKGROUND DATA: Over the years mesh repair is proven the gold standard for umbilical and epigastric hernias. The question remains, which mesh should be used? METHODS: In this randomized controlled, multicenter trial, all patients ≥ 18 years with a single, symptomatic, and primary small umbilical or epigastric hernia qualified for inclusion. Flat preperitoneal polypropylene mesh repair was compared with patch repair (PROCEED Ventral Patch) (PVP). RESULTS: A total of 352 patients were randomized; 348 patients received the intervention (n = 177 PVP vs n = 171 mesh). One out of 4 suffered from any kind of complication within 2 years postoperative (27.6%). A significant difference in complications was seen, in favor of polypropylene mesh repair (P = 0.044, 22.1% mesh vs 32.5% PVP). Reoperation was performed in 19 PVP operated patients (10.7%) versus 7 patients with polypropylene mesh repair (4.0%, P = 0.021).No significant differences were seen in recurrences (n = 13, 8.4% PVP vs n = 6, 4.1% mesh, P = 0.127). CONCLUSIONS: In small epigastric and small umbilical hernia repair a flat polypropylene mesh repair was associated with a lower complication rate than PVP repair. No differences in recurrence rates were seen. Combining all complications, the preperitoneal positioned flat polypropylene mesh performed better.

Is there a difference in laparoscopic cholecystectomy performed in a teaching hospital or a general hospital in The Netherlands?

Introduction: Laparoscopic cholecystectomy may have a complicated course with severe complications such as bile duct injury. Studies in other countries than the Netherlands report ambivalent results regarding the influence of a residency program on patient safety, efficacy and financial consequences. This study aims to determine whether there is a difference between laparoscopic cholecystectomy performed in a teaching hospital or a non-teaching general hospital in Dutch clinics. Materials and methods: A prospective cohort study was performed to examine the safety of laparoscopic cholecystectomies in a teaching hospital with a residency program and a general hospital without surgical residents. All consecutive cholecystectomies in these two hospitals between September 2014 and March 2015 were included. Patient characteristics, operative procedure, level of experience, operation time, per- and postoperative complications, mortality, length of hospital stay, re-admittance and conversions to laparotomy were analyzed. Results: A total of 294 consecutive cholecystectomies were performed in both hospitals. Cholecystectomies performed in the teaching hospital took an average of 25 min longer to complete compared with a non-residency setting. Both the number of conversions and the number of re-admissions were not significantly different between both clinics. The residency program showed smaller peroperative liver lesions along with more postoperative complications, with most complications in patients that required a conversion. Discussion: Current practice where residents perform supervised cholecystectomies should not be discouraged. We believe that is safe and lead to an acceptable increase in operation time.

Awareness and management of low anterior resection syndrome: A Dutch national survey among colorectal surgeons and specialized nurses.

INTRODUCTION: Substantial progress has been made in the treatment of rectal cancer in the past two decades. Low anterior resection is a cornerstone in current treatment, combined with neo-adjuvant (chemo-) radiation in selected cases. However, side effects such as increased frequency, urgency and incontinence are seen in a majority of patients postoperatively. These symptoms, referred to as low anterior resection syndrome (LARS), have a severe impact on quality of life. Management of LARS is complex, and surgeons seem to underestimate and misinterpret the impact of symptoms associated with LARS. AIM AND METHODS: We investigated the awareness and management of LARS in The Netherlands, conducting a national survey in which colorectal surgeons and colorectal care nurses were asked for their views on this complex syndrome. RESULTS: 242 health-care professionals participated in the survey. Most participants estimate the prevalence of major LARS is 20-40% after low anterior resection (LAR); a severe underestimation of actual prevalence - around 70%. Only 10% of surgeons use LARS screening tools in the preoperative period, and fewer than half of surgeons use LARS scores before or after a LAR. Although most surgeons inform their patients preoperatively about the changes in bowel function that they may experience after rectal cancer treatment, a majority of these surgeons indicate more information and patient counselling would improve the quality of life of their patients. DISCUSSION: Impact and prevalence of LARS is underestimated by their physicians. Uniform clinical guidelines should be developed to guide physicians in adequate management of patients with LARS.

Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial.

BACKGROUND: Evidence is accumulating that, similar to other ventral hernias, umbilical and epigastric hernias must be mesh repaired. The difficulties involved in mesh placement and in mesh-related complications could be the reason many small abdominal hernias are still primary closed. In laparoscopic repair, a mesh is placed intraperitoneally, while the most common procedure is open surgery is pre-peritoneal mesh placement. A recently developed alternative method is the so-called patch repair, in this approach a mesh can be placed intraperitoneally through open surgery. In theory, such patches are particularly suitable for small hernias due to a reduction in the required dissection. This simple procedure is described in several studies. It is still unclear whether this new approach is associated with an equal risk of recurrence and complications compared with pre-peritoneal meshes. The material of the patch is in direct contact with intra-abdominal organs, it is unknown if this leads to more complications. On the other hand, the smaller dissection in the pre-peritoneal plane may lead to a reduction in wound complications. METHODS/DESIGN: 346 patients suffering from an umbilical or epigastric hernia will be included in a multi-centre patient-blinded trial, comparing mesh repair with patch repair. Randomisation will take place for the two operation techniques. The two devices investigated are a flat pre-peritoneal mesh and a Proceed Ventral Patch®. Stratification will occur per centre. Post-operative evaluation will take place after 1, 3, 12 and 24 months. The number of complications requiring treatment is the primary endpoint. Secondary endpoints are Verbal Descriptor Scale (VDS) pain score and VDS cosmetic score, operation duration, recurrence and costs. An intention to treat analysis will be performed. DISCUSSION: This trial is one of the first in its kind, to compare different mesh devices in a randomized controlled setting. The results will help to evaluate mesh repair for epigastric an umbilical hernia, and find a surgical method that minimizes the complication rate. TRIAL REGISTRATION: Netherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10.

Prospective evaluation of the added value of imaging within the Dutch National Diagnostic Appendicitis Guideline--do we forget our clinical eye?

BACKGROUND: Annually 16,000 appendectomies are performed in the Netherlands, of which 15-20% are negative. In 2010, to reduce this unacceptable percentage of superfluous appendectomies, the Dutch Association for Surgery introduced the 'Appendicitis Guideline'. This guideline recommends the use of imaging. In this observational prospective study the added value of imaging in everyday clinical practice is evaluated. METHODS: All patients with suspected appendicitis were included at the emergency department of a Dutch teaching hospital during the period from September 2011 to May 2012 (n = 350; 237 adults and 113 children under 18 years). Adherence to the guideline was evaluated. RESULTS: 75 Patients (21%) were not referred for imaging because of a low suspicion or alternative diagnosis. In 16 patients (5%) the guideline was not followed. Of the 259 patients (74%) who underwent ultrasonography, 105 (30%) also underwent computed tomography (CT). 127 appendectomies were performed, showing appendicitis in 112 patients (88%); 15 appendectomies (12%) were negative. In the latter group, 12 were performed after false positive imaging results, and 3 following inconclusive imaging results. CONCLUSION: When using imaging in the diagnosis of appendicitis, the percentage of negative appendectomies remains close to the percentage declared as unacceptable by the publishers of the guideline.

[Hypovolaemic shock several days after rib fractures]. / Hypovolemische shock enkele dagen na ribfracturen.

BACKGROUND: A quarter of all patients with rib fractures develop a haemothorax. A haemothorax usually occurs immediately following trauma, but it can also occur with considerable delay. CASE DESCRIPTION: We describe two patients, aged 58 and 51 years, who each had sustained thoracic trauma. After the initial assessment and additional diagnostic testing, the patients were admitted to hospital. On the 4th and 8th day after the trauma, respectively, they developed hypovolaemic shock resulting from a haemothorax. Both patients had multiple rib fractures. CONCLUSION: A delayed haemothorax is rare but in cases of hypovolaemic shock, this dangerous complication of rib fractures should be ruled out.

Benefits of a well-structured diagnostic process in colon cancer.

INTRODUCTION: Preoperative work-up in colorectal cancer is comprehensive and can be time consuming. In our institution, the preoperative track for colorectal patients was reorganized in order to reduce the therapeutic delay and the number of outpatient clinic visits. We assessed the impact upon the patient outcomes. METHODS: All consecutive patients with colon cancer who entered the reorganized preoperative track between January 2008 and December 2009 (n = 87) were retrospectively compared with a consecutively diagnosed traditionally evaluated patient group diagnosed between January 2005 and December 2006 (n = 108). Time between diagnostic procedures and surgery as well as needed number of preoperative outpatient department visits were calculated. All rectal malignancies, patients who received preoperative chemotherapy and/or radiotherapy and patients who underwent emergency procedures were excluded from analysis. RESULTS: Time between colonoscopy and surgery was reduced from [median (25-75%)] 44 (34-54) to 27 (21-34) days, p < 0.001. The number of outpatient department visits declined from 6 (5-7) to 3 (3-4), p < 0.001. Time between first diagnostic test and colonoscopy was reduced from 44 (11-68) to 9 days (0-30), p < 0.001. Time between first diagnostic test and operation was reduced from 85.5 (56-120.5) to 42 days (28-62), p < 0.001. Before the reorganizations, 7% of colonoscopies were ordered by GPs and went up afterwards to 60%. CONCLUSION: Reorganization of traditional logistic routes for patients diagnosed with colon cancer reduces therapeutic delay and improves care. Moreover, the surgeon, gastroenterologist and oncologist can focus on the oncologic patient and his/her family instead of having to perform administrative tasks.

[A man with a painful leg]. / Een man met pijn in het been.

A 72-year-old man with a history of prostate cancer was seen with pain in the right leg and the left arm. He suffered from a clostridial myonecrosis. Physical examination showed typical findings of purple discoloration of the skin and hemorrhagic bullae. The patient eventually died because of septic shock.

The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037).

BACKGROUND: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). METHODS/DESIGN: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. DISCUSSION: The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis. TRIAL REGISTRATION: Nederlands Trial Register NTR2037.

MRI after chemoradiotherapy of rectal cancer: a useful tool to select patients for local excision.

PURPOSE: If identification of good responders to neoadjuvant chemoradiotherapy in rectal cancer is possible, there might be opportunities for local excision in selected patients. The aim of this study was to determine whether postchemoradiation MRI in rectal cancer can accurately identify ypT0 to 2/ypN0, because both features are essential for identification of good responders. METHODS: Seventy-nine patients (4 hospitals) underwent postchemoradiation MRI, 62 received a lymph node-specific contrast agent (ultrasmall superparamagnetic iron oxide). An expert and general radiologist prospectively predicted whether the tumor penetrated the mesorectal fat and whether nodes were sterilized after chemoradiation. Histology was the reference standard. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated. RESULTS: For prediction of whether a tumor penetrated the bowel wall, there was an negative predictive value of 0.90 and 0.76 for the expert and general radiologist, respectively. The negative predictive value for prediction of nodal status was 0.95 and 0.85 for expert and general radiologist, respectively. CONCLUSION: This prospective multicenter study demonstrates that MRI with a lymph node-specific contrast agent interpreted by an expert radiologist can select ypT0 to 2/ypN0 rectal cancer with low risk of undetected nodal metastases or invasion through the bowel wall. These patients could thus have been selected for local excision. However, future studies will have to prove equal outcome of such a modified surgical approach compared with current practice.

Long-term quality of life in patients with rectal cancer: association with severe postoperative complications and presence of a stoma.

PURPOSE: The purpose of this study was to evaluate the impact of postoperative complications and the presence of a stoma on long-term quality of life in patients with rectal cancer. METHODS: Consecutive patients with an adenocarcinoma of the rectum who underwent surgery at Maastricht University Medical Center or VieCuri Medical Center between 2003 and 2005 were included in this study. Data on surgical treatment and complications were collected. Severe postoperative complications were classified according to a standardized complication severity score. Quality of life was assessed by use of the European Organization for Research and Treatment of Cancer core and colorectal cancer-specific quality-of-life questionnaires. RESULTS: One hundred seventy patients received a questionnaire, and 121 (71%) responded. Of the responders, 33 (27.3%) patients suffered from severe postoperative complications. The median follow-up was 36 months. In the univariate analysis, patients with severe postoperative complications had a lower score on physical functioning (73 vs. 85, P = 0.031) and higher scores on pain (17 vs. 0, P = 0.025) and fatigue (33 vs. 22, P = 0.036). Stoma construction (n = 51) was associated with a higher global health status (83 vs. 75, P = 0.019), and these patients reported fewer gastrointestinal problems (P = 0.001). CONCLUSION: Severe postoperative complications seem to be associated with several lower quality-of-life subscores over the long term. In contrast, a stoma is associated with improved global health status and leads to fewer gastrointestinal complaints. In patients prone to complications, it may be sensible to avoid creating a low anastomosis and to construct a permanent stoma immediately.

Long-term follow-up of dynamic graciloplasty for fecal incontinence.

PURPOSE: Graciloplasty has been used as a treatment for end-stage fecal incontinence since 1946. Electric stimulation with an implantable pulse generator has existed for 15 years. The gracilis muscle is wrapped around the anal canal and stimulated by intramuscular electrodes connected with an implantable pulse generator. Initial reports have been promising, but long-term results have not been presented to date. METHODS: Data of 200 consecutive patients with a follow-up of at least two years were analyzed in a prospective manner from 1986 until 1999. RESULTS: The overall success rate was 72 percent. In patients with fecal incontinence caused by trauma, the rate was 82 percent. Once continent, patients remained continent after a median follow-up of 261 (standard deviation, 132) weeks. Median survival of the implantable pulse generator until battery expiration was 405 weeks. Disturbed evacuation remained a problem in 16 percent of all patients. Complications were frequent but treatable. CONCLUSION: Dynamic graciloplasty is a good, cost-effective treatment for fecal incontinence with results lasting for a median of more than five years.