Concordance between COVID-19 mortality statistics derived from clinical audit and death certificates in Östergötland county, Sweden.

OBJECTIVES: Despite early notions that correct attribution of deaths caused by SARS-CoV-2 infection is critical to the understanding of the COVID-19 pandemic, three years later, the accuracy of COVID-19 death counts is still contested. We aimed to compare official death statistics with cause-of-death assessments made in a clinical audit routine by experienced physicians having access to the full medical record. STUDY DESIGN: Health service quality evaluation. METHODS: In Östergötland county (pop. 465,000), Sweden, a clinical audit team assessed from the start of the pandemic the cause of death in individuals having deceased after testing positive for SARS-CoV-2. We estimated the concordance between official data on COVID-19 deaths and data from the clinical audit using correlations (r) between the cause-of-death categories and discrepancies between the absolute numbers of categorised deaths. RESULTS: The concordance between the data sources was poor regarding whether COVID-19 was the underlying or a contributing cause of death. Grouping of the causes increased the correlations to acceptable strength. Also including deaths implicated by a positive SARS-CoV-2 test in the clinical categorisation of COVID-19 deaths reduced the difference in absolute number of deaths; with these modifications, the concordance was acceptable before the COVID-19 vaccination program was initiated (r = 0.97; symmetric mean absolute percentage error (SMAPE) = 19%), while a difference in the absolute numbers of deaths remained in the vaccination period (r = 0.94; SMAPE = 35%). CONCLUSIONS: This study highlights that carefulness is warranted when COVID-19 death statistics are used in health service planning and resonates a need for further research on cause-of-death recording methodologies.

Palliation of Malignant Biliary Obstruction: Adverse Events are Common after Percutaneous Transhepatic Biliary Drainage.

BACKGROUND AND AIM: Endoscopic stents in the common bile duct is the first treatment choice to alleviate symptoms of biliary obstruction due to malignant disease. When endoscopic stenting fails in palliative patients, one option is to use a percutaneous transhepatic biliary drainage, but it is not clear whether and how it can reduce the symptom load. The aim of this study was to evaluate benefits and disadvantages of percutaneous transhepatic biliary drainage in palliative care. MATERIAL AND METHODS: Inclusion criteria were malignant disease and bilirubin ≥26 µmol/L in plasma. A structured protocol for obtaining data from the medical records was used. Data were collected from the time of last computed tomography scan before the percutaneous transhepatic biliary drainage was placed and during 14 days afterward. RESULTS AND CONCLUSION: Inclusion criteria were fulfilled in 140 patients. Median age was 70 years (33-91 years). Some 126 patients had a remaining external percutaneous transhepatic biliary drainage. Jaundice was the initial symptom in 62 patients (44%). Within the first week after percutaneous transhepatic biliary drainage, the bilirubin decreased from 237 µmol/L (31-634) to 180 µmol/L (17-545). Only 25% reached a level below the double upper reference value. Pruritus occurred in 27% before the percutaneous transhepatic biliary drainage, but the bilirubin value did not differ from patients without pruritus. However, the pruritus was relieved in 56% with percutaneous transhepatic biliary drainage. Antibiotic prophylaxis protected to some extent from infectious complications. Adverse events were common and early mortality was high (16% within 14 days). Jaundice should not by itself be an indication for percutaneous transhepatic biliary drainage for palliation except when the aim is to prepare the patient for chemotherapy. It is mandatory that the patients are informed carefully about what can be expected regarding the positive effects and the risks of adverse events.

Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial.

AIM: Adhesions are the most common cause of small bowel obstruction (SBO). The costs of hospitalization and surgery for SBO are substantial for the health-care system. The adhesion-limiting potential of icodextrin has been shown in patients undergoing surgery for gynaecological diseases. A randomized, multicentre trial in colorectal cancer surgery started in 2009 with the aim of evaluating whether icodextrin could reduce the long-term risk of surgery for SBO. Because of some concerns about complications (especially anastomotic leakage) after icodextrin use, a preplanned interim analysis of morbidity and mortality was conducted. METHOD: Patients with colorectal cancer without metastasis were randomized 1:1 to receive standard surgery, with or without instillation of icodextrin in the abdominal cavity. For the first 300 patients, the 30-day follow-up data were collected from the Swedish ColoRectal Cancer Registry (SCRCR). Pre-, per- and postoperative data, morbidity and mortality were analysed. RESULTS: Of the 300 randomized patients, 288 had a data file in the SCRCR. Twelve patients did not have cancer and another five did not have a resection, leaving 283 for analysis. The authors were blinded to the randomization groups. Demographic data were similar in both groups. The overall complication rate was 24% in Group 1 and 23% in Group 2 (P = 0.89). Four cases of anastomotic leakage were reported in Group 1 and five were reported in Group 2 (P = 1.0). Mortality, intensive care unit (ICU) stay and re-operations did not differ between the groups. CONCLUSION: The pre-planned safety analysis of the first 300 patients enrolled in this randomized trial did not show any differences in adverse effects related to the use of icodextrin. All data were gathered from the SCRCR, giving us a strong message that we can continue to include patients in the trial.

Variation at presentation among colon cancer patients with metastases: a population-based study.

AIM: The study aimed to describe and follow a 2 year cohort of colon cancer patients with Stage IV disease from presentation to long-term outcome. METHOD: The records of 177 colon cancer patients diagnosed in southeast Sweden during 2009-2010 with disseminated disease at presentation were reviewed retrospectively. RESULTS: The patients were heterogeneous with respect to age, performance status and survival. Despite metastatic disease, local symptoms from the primary tumour dominated the initial clinical picture. Forty-one per cent had anaemia. The time from suspicion of colon cancer to established diagnosis of disseminated disease varied from 0 to 231 days (emergency cases included, median 12 days). The majority (77%) were diagnosed in hospital. In 53% the primary tumour and the metastases were not diagnosed on the same occasion which may increase the risk for misinformation or delays in the care process. The possibility of simultaneous diagnosis was doubled when the patient was investigated as an inpatient. Patients were seen by one to 12 physicians (median three) in the investigation phase, and one to 47 (median 11) from diagnosis until the last record in the hospital notes. The 1-year survival was 46%. CONCLUSION: Patients with metastatic colon cancer at presentation are heterogeneous and warrant an adapted multidisciplinary approach to achieve the goal of individualized treatment for each patient in accordance with the Swedish national cancer strategy.

Outcome of 132 consecutive reconstructive operations for intestinal fistula--staged operation without primary anastomosis improved outcome in retrospective analysis.

AIM: To study factors that influenced healing and survival after attempted closure of enterocutaneous fistula. MATERIAL AND METHODS: Retrospective analysis of prospective data concerning 101 patients operated on 132 instances for 110 enterocutaneous fistulae at two hospitals. RESULTS: In all, 96 (87%) of the 110 fistulae healed and 92 (91%) patients survived. A total of 9 patients with unhealed fistula died. Multivariate analysis revealed jaundice as an independent factor for both death and failed closure and operation without anastomosis as an independent positive factor for healing. Failure rate was lower after an operation with stoma without anastomosis (6 of 43, 14%) than after an operation with anastomosis (30 of 89, 34%) p = 0.0213. Of the 36 instances with unhealed fistula, 13 (36%) could be ascribed to inadvertent bowel lesions at the reconstructive operation. In addition, univariate analysis revealed that patients with previous multiple laparotomies or with multiple operations for enterocutaneous fistula healed less likely and had higher mortality. A low serum albumin, high white blood cell count, high C-reactive protein concentration, high fistula output, total parenteral nutrition, and operation for recurrent fistula were associated with death together with long operation time and operative bleeding, both indicators of surgical complexity. Over time, staged surgery avoiding anastomosis increased from 27% to 57%. Mortality decreased from 12% to 6%, and healing increased from 73% to 94%. CONCLUSIONS: Chronic inflammation, malnutrition, and liver failure causing an impaired healing capacity are important reasons for failure. Staged operation without primary anastomosis may allow the patient to reverse this condition and improve outcome. The high surgical complexity is a negative factor that requires careful planning of the operation.

Early and late symptomatic anastomotic leakage following low anterior resection of the rectum for cancer: are they different entities?

AIM: The aim of the study was to compare patients with symptomatic anastomotic leakage following low anterior resection of the rectum (LAR) for cancer diagnosed during the initial hospital stay with those in whom leakage was diagnosed after hospital discharge. METHOD: Forty-five patients undergoing LAR (n = 234) entered into a randomized multicentre trial (NCT 00636948), who developed symptomatic anastomotic leakage, were identified. A comparison was made between patients diagnosed during the initial hospital stay on median postoperative day 8 (early leakage, EL; n = 27) and patients diagnosed after hospital discharge at median postoperative day 22 (late leakage, LL; n = 18). Patient characteristics, operative details, postoperative course and anatomical localization of the leakage were analysed. RESULTS: Leakage from the circular stapler line of an end-to-end anastomosis was more common in EL, while leakage from the stapler line of the efferent limb of the J-pouch or side-to-end anastomosis tended to be more frequent in LL (P = 0.057). Intra-operative blood loss (P = 0.006) and operation time (P = 0.071) were increased in EL compared with LL. On postoperative day 5, EL performed worse than LL with regard to temperature (P = 0.021), oral intake (P = 0.006) and recovery of bowel activity (P = 0.054). Anastomotic leakage was diagnosed most often by a rectal contrast study in EL and by CT scan in LL. The median initial hospital stay was 28 days for EL and 10 days for LL (P < 0.001). CONCLUSION: The present study has demonstrated that symptomatic anastomotic leakage can present before and after hospital discharge and raises the question of whether early and late leakage after LAR may be different entities.

Long-term quality of life in patients with permanent sigmoid colostomy.

AIM: The study aimed to assess quality of life (QoL) in patients with a sigmoid colostomy using a simple general and disease-specific instrument. A subgroup not doing well was identified and examined further. METHOD: The Short Health Scale (SHS) is a four-item instrument exploring severity of symptoms, function in daily life, worry, and general well-being, using visual analogue scales ranging from 0 to 100 where 100 is the worst possible situation. The SHS was delivered to 206 patients with a sigmoid colostomy. It was returned by 181 (87.9%) patients [88 men; median age 73 (33-91) years]. Follow-up was 61 (10-484) months for 178 (86.4%) patients returning usable questionnaires. A subgroup of 16 patients scoring more than 50 in all four items of the SHS was further examined with StomaQOL where 100 is best possible. RESULTS: The median score for severity of symptoms was 18 (2-95), function in daily life 21 (0-95), worry 17 (3-98) and general well-being 22 (0-99). A score of < 50 in the SHS was recorded in 84.9%, 82.1%, 79.9% and 70.5% respectively. In the group scoring more than 50 in all four items patients diagnosed with irritable bowel syndrome constituted 43.8% to compare with 5.6% in the entire study group (P < 0.001). Median score for StomaQOL was 37 (22-62) in this group. CONCLUSION: Most patients with a permanent sigmoid colostomy have a good QoL consistent with previous findings. However, this is reduced in a subgroup of patients diagnosed with irritable bowel syndrome.

Split stoma in resectional surgery of high-risk patients with ileocolonic Crohn's disease.

AIM: The aim of this retrospective study of ileocolonic resection in patients with Crohn's disease was to compare the outcome of primary anastomosis with that of split stoma and delayed anastomosis in a high-risk setting. METHOD: From 1995 to 2006, 132 patients had 146 operations for ileocolonic Crohn's disease. Preoperative data, including risk factors for complications, were obtained from a prospectively registered database. Operations on patients who had two or more preoperative risk factors (n = 76) were considered to be high-risk operations and formed the main study. Primary outcome variables were postoperative anastomotic complications and the alteration in the number of preoperative risk factors achieved by a delayed anastomosis. Secondary outcome was time in hospital and the number of operations performed. RESULTS: Early anastomotic complications were diagnosed in 19% (11/57) of patients receiving a primary anastomosis compared with 0% (0/19) of patients after a delayed anastomosis (P = 0.038). The mean number of risk factors in the split stoma group was 3.5 at the time of resection and 0.2 when the split stoma was reversed (P < 0.0001). The total number of operations was 1.9 ± 1.5 (mean ± SD) after a primary anastomosis and 2.0 ± 0.2 after a split stoma (P = 0.70). Total in-hospital time for all operations was 20.9 ± 35.6 days after a primary anastomosis and 17.8 ± 10.4 days after a delayed anastomosis (P = 0.74). CONCLUSION: Delayed anastomosis after ileocolonic resection in high-risk Crohn's disease patients was associated with a reduction in the number of preoperative risk factors and fewer anastomotic complications. Hospital stay and number of operations were similar after delayed and primary anastomosis in high-risk patients.

Proposal: a score to select patients for fistulotomy.

Traditionally the distance between the inner opening and the anal verge is considered when making the decision to lay open an anal fistula or not. In contrast to this, the score presented here includes the distance to the upper border of the puborectalis muscle or to the external sphincter (anteriorly). In addition this score also takes various aspects of bowel function into consideration.

Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection for rectal cancer.

OBJECTIVE: The aim of this study was to investigate patients with symptomatic anastomotic leakage diagnosed after hospital discharge. METHOD: Patients (n = 234) undergoing low anterior resection of the rectum for cancer who were included in a prospective multicentre trial (NCT 00636948) and who developed symptomatic anastomotic leakage diagnosed after hospital discharge (late leakage, LL; n = 18) were identified. Patient characteristics, operative details, recovery on postoperative day 5, length of hospital stay, and how the leakage was diagnosed were recorded. A comparison with those who did not develop symptomatic leakage (no leakage, NL; n = 189) was made. The minimum follow up was 24 months. RESULTS: In the LL patients the median age was 69 years, 61% were female patients, and 6% had stage IV cancer disease. On postoperative day 5, the LL group had a postoperative course similar to the NL group regarding temperature, oral intake and bowel function. The proportion of patients on antibiotic treatment on postoperative day 5, regardless of indication, was 28% in the LL compared with 4% in the NL group (P < 0.001). The median initial hospital stay was 10 days for both groups. When readmission for any reason was added, the hospital stay rose to a median of 21.5 and 13 days in the LL and the NL groups respectively (P < 0.001). CONCLUSION: Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection of the rectum for cancer is not uncommon and has an immediate clinical postoperative course which may appear uneventful.

Anastomotic-vaginal fistula (AVF) after anterior resection of the rectum for cancer--occurrence and risk factors.

OBJECTIVE: The aim of the study was to assess recto-vaginal fistula (RVF) after anterior resection of the rectum for cancer with regard to occurrence and risk factors. METHOD: All female patients [median age 69.5 years, Union Internationale centre le Cancer (UICC) cancer stage IV in 10%] who developed a symptomatic RVF (n = 20) after anterior resection of the rectum for cancer from three separate cohorts of patients were identified and compared with those who developed conventional symptomatic leakage (n = 32), and those who did not leak (n = 338). Patient demography and perioperative data were compared between these three groups. Fourteen patient-related and surgery-related variables thought to be possible risk factors for RVF (anastomotic-vaginal fistula) were analysed. RESULTS: Symptomatic anastomotic leakage occurred in 52 (13.3%) of 390 patients. Twenty (5.1%) had an anastomotic-vaginal fistula (AVF) and 32 (8.2%) conventional leakage (CL). Patients with AVF required unscheduled re-operation and defunctioning stoma as often as those with CL. AVF was diagnosed later and more often after discharge from hospital compared with CL. Patients with AVF had lower anastomoses and decreased BMI compared with those with CL. Risk factors for AVF in multivariate analysis were anastomosis < 5 cm above the anal verge (P = 0.001), preoperative radiotherapy (P = 0.004), and UICC cancer stage IV (P = 0.005). Previous hysterectomy was a risk factor neither for AVF nor for CL. CONCLUSION: Anastomotic-vaginal fistula forms a significant part of all symptomatic leakages after low anterior resection for cancer in women. Although diagnosed later, the need for abdominal re-operation and defunctioning stoma was not different from patients with CL. Risk factors for AVF included low anastomosis, preoperative radiotherapy and UICC cancer stage IV.

Randomized clinical trial of stapled haemorrhoidopexy performed under local perianal block versus general anaesthesia.

BACKGROUND: The aim was to assess the feasibility of performing stapled haemorrhoidopexy under local anaesthesia. METHODS: Fifty-eight patients with haemorrhoid prolapse were randomized to receive local or general anaesthesia. The perianal block was applied immediately peripheral to the external sphincter. Submucosal block was added after applying the purse-string suture. Patients reported average and peak pain daily for 14 days using a visual analogue scale (VAS). They also completed anal symptom questionnaires before the operation and at follow-up. The surgeon assessed the restoration of the anal anatomy 3-6 months after surgery. RESULTS: The anal block was sufficient in all patients. The mean accumulated VAS score for average pain was 23.1 in the general anaesthesia group and 29.4 in the local anaesthesia group (P = 0.376); mean peak pain scores were 42.1 and 47.9 respectively (P = 0.537). Mean change in symptom load was also similar between the groups, with score differences of 7.0 in the general anaesthesia group and 6.1 in the local anaesthesia group. No patient had a recurrence of prolapse. CONCLUSION: Perianal local block is easy to apply with a high degree of acceptability among patients. Postoperative pain, restoration of anatomy and symptom resolution were similar to that of stapled haemorrhoidopexy performed under general anaesthesia. REGISTRATION NUMBER: ISRCTN19930199 (http://www.controlled-trials.com).

The Swedish rectal cancer registry.

BACKGROUND: An audit of all patients with rectal cancer in Sweden was launched in 1995. This is the first report from the Swedish Rectal Cancer Registry (SRCR). METHODS: Between 1995 and 2003, 13 434 patients treated for adenocarcinoma of the rectum were registered with the SRCR; there were approximately 1500 new patients annually. RESULTS: Approximately half had an anterior resection, a quarter an abdominoperineal resection and 15 per cent a Hartmann's procedure. The median 30-day postoperative mortality rate was 2.4 per cent and the overall postoperative morbidity rate was 35.0 per cent. The 5-year cancer-specific survival rate was 62.3 per cent. The 5-year relative survival rate was 70.1 per cent after anterior resection, 59.8 per cent after abdominoperineal resection and 39.8 per cent after a Hartmann's procedure. The crude 5-year local recurrence rate was 9.5 per cent overall, 6.1 per cent after preoperative radiotherapy and 11.4 per cent after surgery alone. For 3868 patients who had a locally curative procedure the local recurrence rate was 7.4 per cent overall, 5.9 per cent for those who had radiotherapy and 10.2 per cent for those who did not. The local recurrence rate was 2.9 per cent (28 of 968) for stage I disease, 7.9 per cent (112 of 1418) for stage II, 13.9 per cent (188 of 1357) for stage III and 8.5 per cent (45 of 532) for stage IV. CONCLUSION: These good population-based results are due, in part, to the nationwide prospective quality assurance registration.

Population-based study of risk factors for postoperative death after anterior resection of the rectum.

BACKGROUND: The aim of this population-based study was to analyse risk factors for death within 30 days after anterior resection of the rectum. METHODS: Between 1987 and 1995 a total of 6833 patients underwent elective anterior resection of the rectum in Sweden. One hundred and forty of these patients died within 30 days or during the initial hospital stay. These patients were compared with a randomly chosen cohort of 423 patients who underwent the same operation during the same interval, and were alive after 30 days and discharged from hospital. The association between death and 12 putative risk factors was studied. RESULTS: The mortality rate after elective anterior resection was 2.1 per cent (140 of 6833). The incidence of clinical anastomotic leakage was 42.1 per cent (59 of 140) among those who died and 10.9 per cent (46 of 423) in the cohort group. Multivariate regression analysis identified clinical leakage, increased age, male sex, Dukes' 'D' stage and intraoperative adverse events as independent risk factors for death within 30 days. CONCLUSION: Clinical anastomotic leakage was a major cause of postoperative death after anterior resection.

Sporadic adenomatous polyp regression with exisulind is effective but toxic: a randomised, double blind, placebo controlled, dose-response study.

BACKGROUND AND AIMS: A 12 month, multicentre, randomised, double blind, placebo controlled, phase 3, dose-response study was carried out. Exisulind inhibits tumour growth by induction of apoptosis. The aim of our study was to investigate if exisulind induces regression of sporadic colonic adenomas. PATIENTS AND METHODS: A 12 month multicentre randomised double blind placebo controlled phase 3 dose response study was carried out. At baseline colonoscopy, left sided polyps (3-10 mm) were tattooed, measured, and left in place. Subjects received exisulind 200 or 400 mg, or placebo daily. Follow up sigmoidoscopy was performed after six months, and removal of any remaining polyps at the 12 month colonoscopy. The primary efficacy variable was change in polyp size from baseline. RESULTS: A total of 281 patients were enrolled and randomised; 155 (55%) fulfilled the criteria for the intention to treat (ITT) analysis and 114 (41%) fulfilled the criteria for the efficacy evaluation analysis (patients who underwent the 12 month colonoscopy). The decrease in median polyp size was significantly greater (p=0.03) in patients who received exisulind 400 mg (-10 mm2) compared with those who received placebo (-4 mm2). Complete or partial response was significantly higher in the exisulind 400 mg group (54.6%) compared with the placebo group (30.2%), and disease progression was significantly lower (6.1% v 27.9%) (p=0.04 and 0.02, respectively). Increased liver enzymes (8.4%) and abdominal pain (14.7%) were also reported at a greater frequency in the exisulind 400 mg group. CONCLUSION: Exisulind caused significant regression of sporadic adenomatous polyps but was associated with more toxicity. This model of polyp regression, short in its term and involving a comparatively small patient sample size, may be the best available tool to assess a therapeutic regimen before launching into large preventive clinical studies.

Intraoperative adverse events and outcome after anterior resection of the rectum.

BACKGROUND: The aim of this population-based study was to analyse the relationship between intraoperative adverse events and outcome after anterior resection. METHODS: All 140 patients who underwent elective anterior resection in Sweden between 1987 and 1995, and who died within 30 days, were compared with a group of 423 randomly selected patients who underwent the same procedure during the same interval but survived the operation. Intraoperative adverse events and intraoperative measures taken were analysed in relation to outcome of surgery. RESULTS: Of those who died, 45.7 per cent had intraoperative adverse events compared with 30.3 per cent in the cohort group. Major bleeding, gross spillage of faeces, and two or more intraoperative adverse events were more common among those who died. When the anastomosis was considered unsatisfactory, it was more frequently reconstructed (restapled or completely resutured), with or without a temporary stoma, in those who survived. The use of a temporary stoma was comparable in the two groups when adverse events were present. CONCLUSION: Intraoperative adverse events were important contributors to morbidity and mortality. Complete reconstruction of an unsatisfactory anastomosis, with or without addition of a temporary stoma, was more frequently performed in the survivors, and may have diminished the risk of postoperative death.

Risk factors for anastomotic leakage after anterior resection of the rectum.

OBJECTIVE: Surgical technique and peri-operative management of rectal carcinoma have developed substantially in the last decades. Despite this, morbidity and mortality after anterior resection of the rectum are still important problems. The aim of this study was to identify risk factors for anastomotic leakage in anterior resection and to assess the role of a temporary stoma and the need for urgent re-operations in relation to anastomotic leakage. PATIENTS AND METHODS: In a nine-year period, from 1987 to 1995, a total of 6833 patients underwent elective anterior resection of the rectum in Sweden. A random sample of 432 of these patients was analysed (sample size 6.3%). The associations between death and 10 patient- and surgery-related variables were studied by univariate and multivariate analysis. Data were obtained by review of the hospital files from all patients. RESULTS: The incidence of symptomatic clinically evident anastomotic leakage was 12% (53/432). The 30-day mortality was 2.1% (140/6833). The rate of mortality associated with leakage was 7.5%. A temporary stoma was initially fashioned in 17% (72/432) of the patients, and 15% (11/72) with a temporary stoma had a clinical leakage, compared with 12% (42/360) without a temporary stoma, not significant. Multivariate analysis showed that low anastomosis (< or = 6 cm), pre-operative radiation, presence of intra-operative adverse events and male gender were independent risk factors for leakage. The risk for permanent stoma after leakage was 25%. Females with stoma leaked in 3% compared to men with stoma who leaked in 29%. The median hospital stay for patients without leakage was 10 days (range 5-61 days) and for patients with leakage 22 days (3-110 days). CONCLUSION: In this population based study, 12% of the patients had symptomatic anastomotic leakage after anterior resection of the rectum. Postoperative 30-day mortality was 2.1%. Low anastomosis, pre-operative radiation, presence of intra-operative adverse events and male gender were independent risk factors for symptomatic anastomotic leakage in the multivariate analysis. There was no difference in the use of temporary stoma in patients with or without anastomotic leakage.

Atopic manifestations are more common in patients with Crohn disease than in the general population.

BACKGROUND: The role of TNF-alpha in Crohn disease is now well established and anti-TNF-alpha is frequently used as a second- or third-line treatment. Tumor necrosis factor-alpha (TNF-alpha) is traditionally associated with macrophages but has recently also been found in mast cells of the ileal wall in patients with Crohn disease. As it is well known that mast cells and TNF-alpha play important roles in atopic manifestations like asthma, allergic rhinitis; and eczema the aim of this study was to investigate whether these are seen more commonly in Crohn patients than in the general population. METHODS: Patients with Crohn disease (n = 308), aged 18-50 years, living in the Linköping region in southeast Sweden, were asked to answer a questionnaire regarding the presence of any kind of atopic manifestations. The questionnaire was also sent to 930 controls collected from the Southeastern Region Population Registry. The controls were matched according to age, sex, and place of residence. RESULTS: The response rate among the Crohn patients was 91% (280/308) and among controls 84% (779/930). Eczema was a significantly more frequent manifestation, being almost twice as common in Crohn patients (27%) as in the general population (16%). Adjustment by logistic regression for place of residence, gender, age and coexistence of any other atopic manifestation did not change the odds ratios significantly. CONCLUSION: Atopic manifestations as a group, and eczema as a single manifestation, are significantly more frequent in Crohn patients than in the general population.

Clinical measurement of pelvic floor movement: evaluation of a new device.

PURPOSE: A new device that measures pelvic floor movement clinically was evaluated. METHODS: The device consists of a rectal balloon with a magnet at its exterior end. The magnet moves in an electromagnetic field synchronous with the pelvic floor movements. This movement is measured and displayed on a computer screen in front of the seated patient. Twenty-eight healthy volunteers (15 females) were examined. On a separate day, 17 of them were tested a second time by the same investigator and a third time by a different investigator. RESULTS: One volunteer developed a vasovagal reaction. The median (range) pelvic floor lift and descent was 2 (range, 0.6-4.5) cm and 1.8 (range, 0.5-5.6) cm respectively. Day-to-day and interobserver reproducibility was good. Coughing and blowing a party balloon caused pelvic floor descent in the majority of participants. Twenty of 28 volunteers were able to expel the rectal balloon. CONCLUSIONS: The device measures cranial and caudal movements of the pelvic floor with minimal discomfort and good reproducibility. The device may have a large potential as biofeedback device in pelvic floor training.

Anal and rectal cancer in Crohn's disease.

Several epidemiological studies have been published regarding the risk of Crohn's disease- associated colorectal cancer. The findings are, however, contradictory and it has been particularly difficult to obtain indisputable information on the incidence of cancer limited to the rectum and the anus. During 1987-2000 rectal or anal cancer was diagnosed in 335 patients in Sweden (153 males, 182 females). In other words, approximately 3 Crohn patients per million inhabitants were diagnosed with rectal or anal cancer every year during that time period which is 1% of the total number of cases. At diagnosis of cancer 36% were aged below 50 years and 58% below 60 years. Corresponding figures for all cases of anal and rectal cancer were 5% and 18%, respectively. Present knowledge from the literature implies that there is an increased risk of rectal and anal cancer only in Crohn's disease patients with severe proctitis or severe chronic perianal disease. However, the rectal remnant must also be considered a risk factor. Multimodal treatment is similar to that in sporadic cancer but proctectomy and total or partial colectomy is added depending on the extent of the Crohn's disease. The outcome is the same as in sporadic cancer at a corresponding stage but the prognosis is often poor due to the advanced stage of cancer at diagnosis. We suggest that six high-risk groups should be recommended annual surveillance after a duration of Crohn's disease of 15 years including extensive colitis, chronic severe anorectal disease, rectal remnant, strictures, bypassed segments and sclerosing cholangitis.