One-year results of the SCANDIV randomized clinical trial of laparoscopic lavage versus primary resection for acute perforated diverticulitis.

BACKGROUND: Recent randomized trials demonstrated that laparoscopic lavage compared with resection for Hinchey III perforated diverticulitis was associated with similar mortality, less stoma formation but a higher rate of early reintervention. The aim of this study was to compare 1-year outcomes in patients who participated in the randomized Scandinavian Diverticulitis (SCANDIV) trial. METHODS: Between February 2010 and June 2014, patients from 21 hospitals in Norway and Sweden presenting with suspected perforated diverticulitis were enrolled in a multicentre RCT comparing laparoscopic lavage and sigmoid resection. All patients with perforated diverticulitis confirmed during surgery were included in a modified intention-to-treat analysis of 1-year results. RESULTS: Of 199 enrolled patients, 101 were assigned randomly to laparoscopic lavage and 98 to colonic resection. Perforated diverticulitis was confirmed at the time of surgery in 89 and 83 patients respectively. Within 1 year after surgery, neither severe complications (34 versus 27 per cent; P = 0·323) nor disease-related mortality (12 versus 11 per cent) differed significantly between the lavage and surgery groups. Among the 144 patients with purulent peritonitis, the rate of severe complications (27 per cent (20 of 74) versus 21 per cent (15 of 70) respectively; P = 0·445) and disease-related mortality (8 versus 9 per cent) were similar. Laparoscopic lavage was associated with more deep surgical-site infections (32 versus 13 per cent; P = 0·006) but fewer superficial surgical-site infections (1 versus 17 per cent; P = 0·001). More patients in the lavage group underwent unplanned reoperations (27 versus 10 per cent; P = 0·010). Including stoma reversals, a similar proportion of patients required a secondary operation (28 versus 29 per cent). The stoma rate at 1 year was lower in the lavage group (14 versus 42 per cent in the resection group; P < 0·001); however, the Cleveland Global Quality of Life score did not differ between groups. CONCLUSION: The advantages of laparoscopic lavage should be weighed against the risk of secondary intervention (if sepsis is unresolved). Assessment to exclude malignancy (although uncommon) is advised. Registration number: NCT01047462 ( http://www.clinicaltrials.gov).

Impact of mechanical bowel preparation on survival after colonic cancer resection.

BACKGROUND: A randomized study in 1999-2005 of mechanical bowel preparation (MBP) preceding colonic resection found no decrease in postoperative complications. The aim of the present study was to evaluate the long-term effect of MBP regarding cancer recurrence and survival after colonic resections. METHODS: The cohort of patients with colonic cancer in the MBP study was followed up for 10 years. Data were collected from registers run by the National Board of Health and Welfare. Register data were validated against information in patient charts. Cox proportional hazards model was used for multivariable analysis of factors predictive of cancer-specific survival. RESULTS: Register analysis showed significantly fewer recurrences, and better cancer-specific and overall survival in the MBP group. After validation, 839 of 1343 patients remained for analysis (448 MBP, 391 no MBP). Eighty (17·9 per cent) of 448 patients in the MBP group and 88 (22·5 per cent) of 391 in the no-MBP group developed a cancer recurrence (P = 0·093). The 10-year cancer-specific survival rate was 84·1 per cent in the MBP group and 78·0 per cent in the no-MBP group (P = 0·019). Overall survival rates were 58·8 and 56·0 per cent respectively (P = 0·186). CONCLUSION: Patients receiving MBP before elective colonic cancer surgery had significantly better cancer-specific survival after 10 years.

Short-term outcome after neoadjuvant high-dose-rate endorectal brachytherapy or short-course external beam radiotherapy in resectable rectal cancer.

AIM: Total mesorectal excision with preoperative radiotherapy reduces local recurrence in rectal cancer, but radiotherapy increases the risk of complications. This study compared the immediate postoperative outcome after external beam radiotherapy with outome after high-dose-rate endorectal brachytherapy (HDREBT). METHOD: Patients (n = 318) treated with preoperative HDREBT (6.5 Gy, daily, over 4 days) followed by surgery 4-8 weeks later were matched with 318 patients from the Swedish Rectal Cancer Register treated with short-course radiotherapy (SCRT; 5 Gy, daily, over 5 days) and surgery in the subsequent week and with 318 patients who had surgery only (i.e. no preoperative radiotherapy; RT-) All 954 patients were followed for 30 days after surgery. Complications were divided into surgical, cardiovascular and infectious. RESULTS: The SCRT group had fewer cardiovascular complications (3.1%) than did HDREBT (9.4%, P = 0.002) and RT- (7.2%, P = 0.03) groups. There was less perioperative bleeding in HDREBT patients (379.3 ml) than in SCRT (947.2 ml; P < 0.0001) or RT- (918.9 ml) patients, and the re-intervention rate was lower in HDREBT (4.1%) patients than in SCRT (14.2%; P = 0.005) and RT- (12.3%; P < 0.005) patients. The HDREBT group had fewer R2 resections than did the SCRT and RT- groups, but had a higher proportion of R0 resections compared with the RT- group (P = 0.03). CONCLUSION: No major differences in postoperative complications were found. HDREBT patients had a higher rate of cardiovascular complications, but less perioperative bleeding and fewer re-interventions. A longer interval between radiotherapy and surgery may be beneficial for tumour regression and this could be reflected in the number of radical resections.

Effect of local gentamicin-collagen on perineal wound complications and cancer recurrence after abdominoperineal resection: a multicentre randomized controlled trial.

AIM: Perineal wound sepsis is a common problem after abdominoperineal resection of the rectum (APR), with a reported incidence of 10-15% in previously non-irradiated patients, 20-30% in patients given preoperative radiation and 50% among patients submitted to preoperative radiation combined with chemotherapy. The local application of gentamicin-collagen was evaluated to determine whether its use in the perineal wound reduced risk complications and had an effect on cancer recurrence. METHOD: In this prospective multicentre (seven hospitals) randomized controlled trial, 102 patients undergoing APR due to cancer or benign disease were randomized into two groups including surgery with gentamicin-collagen (GS+, n = 52) or surgery without gentamicin-collagen (GS-, n = 50). Patients were followed at 7, 30 and 90 days and at 1 and 5 years. RESULTS: There were no statistically significant differences between the two groups regarding perineal wound complications, infectious or non-infectious, or cancer recurrence. CONCLUSION: There was no statistically significant effect on perineal wound complications or cancer recurrence following the local administration of gentamicin-collagen during APR.

The Easy-X magnetic stoma connector system. A future concept for stomal dressing?

AIM: A considerable proportion of stoma patients are disabled for various reasons and are elderly. To be able to dress their stoma themselves is of crucial importance for their integrity and social life. This study evaluates a novel stomal dressing system based on a magnetic connector--the Easy-X system. METHOD: Twenty patients (8 women, mean age of 40-89 years) with a well-functioning colostomy tested the Easy-X system for 6 weeks. The system was judged by the patients using a multiple choice scale, and by the stoma nurses using a 10-grade VAS. RESULTS: Eighteen of 20 patients completed the trial. Ten patients rated the Easy-X as better than their ordinary system, 3 as equal to and 4 deemed it inferior. Despite this, only three were prepared to change to the Easy-X system. Eleven of 18 patients experienced discomfort with the new adhesive plate. Three patients suffered leakage less often and five patients more often than with their ordinary system. Stoma nurse ratings were available for 14 patients. Their evaluation of the magnetic connector in the Easy-X system was positive in eight cases, neutral in one case and negative in three cases. Global impression ratings were 3 positive, 3 negative and 5 neutral. CONCLUSION: The Easy-X system showed potential advantages over conventional stomal dressing systems, but the system must be improved in terms of a varied assortment of dressing products enabling individual fitting before a larger trial can be carried out on disabled patients. Furthermore, the increased use of metal has to be handled with an ecologic recycling system. WHAT IS NEW IN THIS PAPER: A new stomal dressing system with a magnetic connector has potential advantages over conventional stomal dressings for disabled persons.

Multicentre analysis of oncological and survival outcomes following anastomotic leakage after rectal cancer surgery.

BACKGROUND: The association between diverting stomas and symptomatic anastomotic leakage after rectal cancer surgery was studied, as well as the impact of leakage on local recurrence, distant metastasis, and disease-free, overall and cancer-specific survival. METHODS: Data from the Swedish Rectal Cancer Trial, Dutch TME trial, CAO/ARO/AIO-94 trial, EORTC 22921 trial and Polish Rectal Cancer Trial were pooled (n = 5187). All eligible patients without distant metastases at the time of low anterior resection were selected (n = 2726); overall survival was studied in patients aged 75 years or less (n = 2480). Multivariable models were used to study the association between diverting stomas and anastomotic leakage, and between leakage and recurrence or survival. RESULTS: Some 9.7 per cent of patients were diagnosed with a symptomatic anastomotic leak; diverting stomas were negatively associated with leakage (11.6 per cent without and 7.8 per cent with a stoma; P = 0.002). Anastomotic leakage was negatively associated with overall survival in the multivariable analysis (hazard ratio (HR) 1.29 (95 per cent confidence interval 1.02 to 1.63); P = 0.034), but not with cancer-specific survival (HR 1.12 (0.83 to 1.52); P = 0.466). CONCLUSION: Diverting stomas were associated with less symptomatic anastomotic leakage. Oncological outcome was not significantly influenced by leakage, but overall survival was reduced.

Circular 'superelastic' compression anastomosis: from the animal lab to clinical practice.

The recent development of a compression device using shape memory Nitinol technology to create an end-to-end anastomosis has renewed the interest in sutureless anastomotic techniques. A phase II, prospective open label clinical trial was started in May 2007 to evaluate the feasibility and safety of this new anastomotic device. Fourty patients who need left colectomy or high anterior resection for either diverticular disease or adenocarcinoma will be recruited in two academic hospitals (Uppsala,Sweden and Leuven, Belgium). Clinical leakage is the primary endpoint. Only preliminary results are available to date as the recruitment is ongoing. The median age of the first ten patients is 57.5 years (44-72). No anastomotic leakage occurred. The median hospital stay was 4.0 days. Only three patients noticed the passage of the ring through the anal canal. By three weeks no ring was sustained in the gastrointestinal tract as was objectified by plain X-ray. First clinical use of this new anastomotic device seems promising. Final results for the total phase II trial are awaited. A prospective randomized trial to compare the efficacy of the EndoCar 28 with conventional stapling should be the next step.

Population-based study of local surgery for rectal cancer.

BACKGROUND: The aim was to determine long-term survival and recurrence rates after local excision of rectal cancer from a prospectively registered population-based database. METHODS: Swedish Rectal Cancer Registry data from 1995 to 2001, including 10 181 patients of whom 643 (6.3 per cent) had a local excision, were analysed. Complete 5-year follow-up data from 1995 to 1998 were available. Cumulative relative and cancer-specific survival rates, and rates of local recurrence and distant metastases, were calculated by actuarial methods. RESULTS: The 5-year cancer-specific survival rate for 256 patients with stage I disease who had local excision was 95.3 (95 per cent confidence interval 91.5 to 99.1) per cent. The 5-year local recurrence rate was 7.2 per cent. After adjustment for age, sex, tumour stage and preoperative radiotherapy, the relative risk of death from cancer was the same as that after major resection. CONCLUSION: Population-based results after local excision of rectal cancer are the same as those reported in controlled series for early-stage tumours after abdominal resection. A low relative survival and a high median age indicate the use of local excision in patients with a high level of co-morbidity. To achieve acceptable long-term results, optimal preoperative and postoperative staging is needed.

Separation of healthy and early osteoarthritis by automatic quantification of cartilage homogeneity.

OBJECTIVE: Cartilage loss as determined either by magnetic resonance imaging (MRI) or by joint space narrowing in X-rays is the result of cartilage erosion. However, metabolic processes within the cartilage that later result in cartilage loss may be a more accurate assessment method for early changes. Early biological processes of cartilage destruction are among other things, a combination of proteoglycan turnover, as a result of altered charge distributions, and local alterations in water content (edema). As water distribution is detectable by MRI, the aim of this study was to investigate cartilage homogeneity visualized by MRI related to water distribution, as a potential very early marker for early detection of knee osteoarthritis (OA). DESIGN: One hundred and fourteen right and left knees from 71 subjects aged 22-79 years were scanned using a Turbo 3D T(1) sequence on a 0.18T MRI Esaote scanner. The medial compartment of the tibial cartilage sheet was segmented using a fully automatic voxel classification scheme based on supervised learning. From the segmented cartilage sheet, homogeneity was quantified by measuring entropy from the distribution of signal intensities inside the compartment. For each knee an X-ray was acquired and the knees were categorized by the Kellgren and Lawrence (KL) index and the joint space width (JSW) was measured. The P-values for separating the groups by each of JSW, cartilage volume, cartilage mean intensity, and cartilage homogeneity were calculated using the unpaired t-test. RESULTS: The P-value for separating the group diagnosed as KL 0 from the group being KL 1 based on JSW, volume and mean signal intensity the values were P=0.9, P=0.4 and P=0.0009, respectively. In contrast, the P-value for homogeneity was P=0.0004. The precision of the measures assessed, as a test-retest root mean square coefficient of variation (RMS-CV%) was 3.9% for JSW, 7.4% for volume, 3.9% for mean signal intensity and 3.0% for homogeneity quantification. CONCLUSION: These data demonstrate that the distribution of components of the articular matrix precedes erosion, as measured by cartilage homogeneity related to water concentration. We show that homogeneity was able to separate early OA from healthy individuals in contrast to traditional volume and JSW quantifications. These data suggest that cartilage homogeneity quantification may be able to quantify early biochemical changes in articular cartilage prior to cartilage loss and thereby provide better identification of patients for OA trials who may respond better to medicinal intervention of some treatments. In addition, this study supports the feasibility of using low-field MRI in clinical studies.

Automatic morphometric cartilage quantification in the medial tibial plateau from MRI for osteoarthritis grading.

OBJECTIVE: To evaluate whether a novel, fully automatic, morphometric cartilage quantification framework is suitable for assessing level of knee osteoarthritis (OA) in clinical trials. METHOD: The population was designed with a normal population and groups with varying degree of OA of both sexes and at ages from 21 to 78. Posterior-anterior X-rays were acquired in semi-flexed, load-bearing position. The radiographic signs of OA were evaluated based on the Kellgren and Lawrence score (KL) and the joint space width (JSW) was measured. Turbo 3D T1 magnetic resonance imaging (MRI) scans were acquired with resolution 0.7x0.7x0.8mm(3) from a 0.18T scanner. The morphometric cartilage quantification from MRI resulted in volume, surface area, thickness and surface curvature for the medial tibial cartilage compartment. These quantifications were evaluated against JSW with respect to precision and ability to separate healthy subjects from OA subjects. RESULTS: The automatic, morphometric cartilage quantifications allowed fairly precise measurements with scan-rescan coefficient of variations (CVs) in the range from 3.4% to 6.3%. All quantifications, including JSW, allowed separation of the groups of healthy and OA subjects. However, for separation of the healthy from the borderline cases (KL 0 vs KL 1), only the Cartilage Curvature quantification allowed statistically significant separation (P<0.01). CONCLUSION: The novel morphometric framework shows promise for use in clinical trials. The ability of the Cartilage Curvature quantification to detect the early stages of OA and the effectiveness of the focal thickness Q10 measure are particularly noteworthy. Furthermore, these results may indirectly support that low-field MRI may be a low-cost option for clinical trials.

The circular stapling device as a risk factor for anastomotic leakage.

AIM: To investigate the relation between the type of circular stapler and anastomotic leak in rectal cancer surgery. BACKGROUND: During the past decades results from rectal cancer surgery have improved considerably regarding risk of local recurrence and survival. Two main paradigm changes are considered to be the cause for this: the introduction of total mesorectal excision (TME) and the increasing use of radiotherapy. However, rectal cancer surgery is associated with an unacceptably high frequency of complications of which anastomotic leak is one of the most severe ones. The hypothesis was raised that the choice of stapler influenced the leakage rates. METHODS: A questionnaire was sent to all departments of surgery (n = 66) performing rectal cancer surgery in Sweden to determine the choice of circular stapler when performing anterior resection for rectal cancer. These data were linked to the Swedish Rectal Cancer Registry for the period 1995-99. RESULTS: A total of 3316 patients had an anterior resection. The choice of circular stapling device was determined in 70% of the cases. When stapler A was used, the leakage rate was 11% whereas it was 7% when stapler B was used (P = 0.0039). In the cases where it was impossible to determine which stapler had been used the leakage rate was 8%. CONCLUSION: Quality control is an important part of medicine and the present study suggests that it also must include surgical instruments. A prospective randomised study is needed to confirm the results.