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In a randomized trial involving more than 1000 patients, outcomes including recurrence rate and overall survival were similar among patients undergoing laparoscopic surgery and those undergoing open surgery. Colorectal cancer is the third most common cancer worldwide and accounts for nearly 1.4 million new cases and 694,000 deaths per year. Approximately one third of all colorectal cancers are localized in the rectum. 1 – 4 Less than a half century ago, rectal cancer had a poor prognosis, with cancer recurrence rates in the pelvic or perineal area (locoregional recurrence) of up to 40% and 5-year survival rates after surgical resection of less than 50%. 5 , 6 In the 1980s, Heald and Ryall 6 introduced a new surgical technique of complete removal of the fatty envelope surrounding the rectum (mesorectum), called total mesorectal . . .

Background Equipment-related malfunctions directly relate to one-fourth of the adverse events in the surgical theater. A serious game trains residents to recognize and respond to equipment problems in minimally invasive surgery (MIS). These include disturbed vision, gas transport, electrocautery, and pathophysiological disturbances. This randomized controlled trial explores whether game-based training improves surgical residents’ response to equipment-related problems during surgery. Methods Thirty-one surgical residents with no previous experience in MIS took part in a standardized basic laparoscopy training course. Fifteen residents were randomly assigned to the game-enhanced curriculum (intervention) and sixteen were assigned to the regular curriculum (control). Participants performed a MIS task in a live anesthetized pig model, during which three standardized equipment malfunction scenarios occurred. Observers recorded the problems recognized and solved, time, and participants’ technical performance. Results Twenty-four participants completed the post-test ( n  = 12 per group). The intervention group solved more problems than the control group (59 vs. 33%, p  = 0.029). The intervention group also recognized a larger proportion of problems, although this parameter was non-significant (67 vs. 42%, p  = 0.14). Random effects modeling showed a significant improved game performance per participant over time. Conclusions Surgical residents, who play for only 1 h on a custom-made serious game, respond significantly better to equipment-related problems during surgery than residents trained by a standard training curriculum. These results imply that entertaining serious games can indeed be considered for use in official training for surgeons and other medical specialists.

Colonic stenting as a bridge to elective surgery is an alternative for emergency surgery in patients with acute malignant colonic obstruction, but its benefits are uncertain. We aimed to establish whether colonic stenting has better health outcomes than does emergency surgery. Patients with acute obstructive left-sided colorectal cancer were enrolled from 25 hospitals in the Netherlands and randomly assigned (1:1 ratio) to receive colonic stenting as a bridge to elective surgery or emergency surgery. The randomisation sequence was computer generated with permuted blocks and was stratified by centre; treatment allocation was concealed by use of a web-based application. Investigators and patients were unmasked to treatment assignment. The primary outcome was mean global health status during a 6-month follow-up, which was assessed with the QL2 subscale of the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30). Analysis was by intention to treat. This study is registered, number ISRCTN46462267. Between March 9, 2007, and Aug 27, 2009, 98 patients were assigned to receive colonic stenting (n=47 patients) or emergency surgery (n=51). Two successive interim analyses showed increased 30-day morbidity in the colonic stenting group, with an absolute risk increase of 0·19 (95% CI −0·06 to 0·41) in analysis of the first 60 patients (14 of 28 patients receiving colonic stenting vs 10 of 32 receiving emergency surgery), and an absolute risk increase of 0·19 (−0·01 to 0·37) in analysis of the first 90 patients (23 of 47 patients vs 13 of 43). In accordance with the advice of the data safety monitoring committee, the study was suspended on Sept 18, 2009, and ended on March 12, 2010. At the final analysis of 98 patients, mean global health status during follow-up was 63·0 (SD 23·8) in the colonic stenting group and 61·4 (SD 21·9) in the emergency surgery group; after adjustment for baseline values, mean global health status did not differ between treatment groups (−4·7, 95% CI −14·8 to 5·5, p=0·36). No difference was recorded between treatment groups in 30-day mortality (absolute risk difference −0·01, 95% CI −0·14 to 0·12, p=0·89), overall mortality (−0·02, −0·17 to 0·14, p=0·84), morbidity (−0·08, −0·27 to 0·11, p=0·43), and stoma rates at latest follow-up (0·09, −0·10 to 0·27, p=0·35). However, the emergency surgery group had an increased stoma rate directly after initial intervention (0·23, 0·04 to 0·40, p=0·016) and a reduced frequency of stoma-related problems (between-group difference −12·0, −23·7 to −0·2, p=0·046). The most common serious adverse events were abscess (three in the colonic stenting group vs four in the emergency surgery group), perforations (six vs none), and anastomotic leakage (five vs one), and the most common adverse events were pneumonia (three vs one) and wound infection (one vs three). Colonic stenting has no decisive clinical advantages to emergency surgery. It could be used as an alternative treatment in as yet undefined subsets of patients, although with caution because of concerns about tumour spread caused by perforations. None.

After colorectal surgery, patients often experience impaired functional outcome. Faecal incontinence grading systems and self-assessment questionnaires are frequently used to assess these complaints. The available faecal incontinence grading systems have been validated, but have a limited focus, while more comprehensive questionnaires, which have been developed, have not been validated. To investigate the reliability and validity of a newly developed, colorectal functional outcome (COREFO) questionnaire and of Dutch translations of the Hallböök questionnaire and an adapted version of the Vaizey questionnaire. Two hundred fifty-seven patients with and without impaired functional outcome after (colorectal) surgery received a booklet containing the three questionnaires in random order by mail. One hundred seventy-nine (70%) completed them, and 160 patients (90%) completed a retest within, on average, 18 days. Reliability and validity were adequate for the COREFO and Hallböök questionnaire, with slight differences in the psychometric analyses in favour of the COREFO questionnaire. Significantly more patients found the COREFO questionnaire to reflect their problems best. The reliability of the Vaizey questionnaire was not sufficient. The newly developed COREFO questionnaire and the previously unvalidated Hallböök questionnaire are both suitable instruments to evaluate functional outcome after colorectal surgery. The psychometric analyses showed a slight difference in favour of the COREFO questionnaire and significantly more patients preferred the COREFO questionnaire to the other questionnaires. Therefore, we prefer to use the COREFO questionnaire in future research.

BackgroundTraditionally uncomplicated acute diverticulitis was routinely treated with antibiotics, although evidence for this strategy was lacking. Recently, two randomized clinical trials (AVOD trial and DIABOLO trial) published short-term results of omitting antibiotics compared to routine antibiotic treatment. Both showed no significant differences regarding recovery from the initial episode, as well as rates of complicated or recurrent diverticulitis and sigmoid resection. However, both studies showed a trend of higher rates of sigmoid resection in the observational groups. Here, the long-term effects of omitting antibiotics in first episode uncomplicated acute diverticulitis were assessed.MethodsA total of 528 patients with CT-proven, primary, left-sided, uncomplicated acute diverticulitis were randomized to either an observational or an antibiotic treatment strategy (DIABOLO trial). Outcome measures were complicated diverticulitis, recurrent diverticulitis and sigmoid resection at 24 months’ follow up. Differences between the groups were explored and risk factors were identified using multivariable logistic regression.ResultsComplete case analyses showed no difference in rates of recurrent diverticulitis (15.4% in the observational group versus 14.9% in the antibiotic group; p = 0.885), complicated diverticulitis (4.8% versus 3.3%; p = 0.403) and sigmoid resection (9.0% versus. 5.0%; p = 0.085). Young patients (<50 years) and patients with a pain score at presentation of 8 or higher on a visual analogue pain scale were at risk for complicated or recurrent diverticulitis. In this multivariable analysis, treatment type (with or without antibiotics) was not an independent predictor for complicated or recurrent diverticulitis.ConclusionOmitting antibiotics in the treatment of uncomplicated acute diverticulitis did not result in more complicated diverticulitis, recurrent diverticulitis or sigmoid resections at long-term follow up. As the DIABOLO trial was not powered for these secondary outcome measures, some uncertainty remains whether (small) non-significant differences could be true associations.

ObjectivesThe I CARE study (Improving Care After colon canceR treatment in the Netherlands) aims to compare surgeon-led to general practitioner (GP)-led colon cancer survivorship care. Recruitment to the trial took longer than expected. In this descriptive study, recruitment is critically reviewed.SettingPatients were recruited from eight Dutch medical centres.ParticipantsPatients treated with curative intent for stages I–III colon cancer. Target patient sample size was calculated at 300.InterventionsPatients were randomised to surgeon-led (usual) versus GP-led care, with or without access to an eHealth application (Oncokompas).Outcome measuresBaseline characteristics of (non-)participants, reasons for non-participation and strategies to improve recruitment were reviewed.ResultsOut of 1238 eligible patients, 353 patients were included. Of these, 50 patients dropped out shortly after randomisation and before start of the intervention, resulting in a participation rate of 25%. Participants were on average slightly younger (68.1 years vs 69.3 years) and more often male (67% vs 50%) in comparison to non-participants. A total of 806 patients declined participation for reasons most often relating to research (57%), including the wish to remain in specialist care (31%) and too much effort to participate (12%). Some patients mentioned health (9%) and confrontation with the disease (5%) as a reason. In 43 cases, GPs declined participation, often related to the study objective, need for financial compensation and time restraints. The generally low participation rate led to concerns about reaching the target sample size. Methods to overcome recruitment challenges included changes to the original recruitment procedure and the addition of new study centres.ConclusionsChallenges were faced in the recruitment to a randomised trial on GP-led colon cancer survivorship care. Research on the transition of care requires sufficient time, funding and support base among patients and healthcare professionals. These findings will help inform researchers and policy-makers on the development of future practices.Trial registration numberNTR4860.

IntroductionNon-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.MethodsIn 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.ResultsBetween 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.ConclusionVacuum-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.

BackgroundIn search of improvement of patient assessment in the postoperative phase, C-reactive protein (CRP) is increasingly being studied as an early marker for postoperative complications following major abdominal surgery. Several studies reported an attenuated immune response in minimally invasive surgery, which might affect interpretation of postoperative CRP levels. The aim of the present study was to compare the value of CRP as a predictor for major postoperative complications in patients undergoing open versus laparoscopic colorectal surgery.MethodsA subgroup analysis from a randomized clinical trial (LAFA-trial) was performed, including all patients with non-metastasized colorectal cancer. In the LAFA trial, patients were randomized to open or laparoscopic segmental colectomy. In a subgroup of 79 patients of the LAFA trial, postoperative assessment of CRP levels was conducted routinely preoperatively and 1, 2, 24 and 72 h after surgery.ResultsThirty-seven patients were randomized to the open group and 42 patients to the laparoscopic group. Major complications occurred in 19% of laparoscopic procedures and 13.5% of open procedures (p = 0.776). CRP levels rise following surgical procedures. In uncomplicated cases, the rise in CRP levels was significantly lower at 24 and 72 h following laparoscopic resection in comparison to open resection. No differences in CRP levels were observed when comparing open and laparoscopic resection in patients with major complications.ConclusionIn patients with an uncomplicated postoperative course, CRP levels were lower following minimally invasive resection, possibly due to decreased operative trauma. No differences in CRP were observed stratified for surgical technique in patients with major complications. These results suggest that CRP may be applied as a marker for major postoperative complications in both open and minimally invasive colorectal surgery. Future research should aim to assess the role of standardized postoperative CRP measurements.

ObjectiveNon-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas.DesignPatients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital.ResultsTwo hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609±209, TEM 652±188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately €3000 cheaper and therefore more cost-effective.ConclusionUnder the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.

BackgroundReceiving a stoma significantly impacts patients’ quality of life. Coping with this new situation can be difficult, which may result in a variety of physical and psychosocial problems. It is essential to provide adequate guidance to help patients cope with their stoma, as this positively influences self-efficacy in return. Higher self-efficacy reduces psychosocial problems increasing patient’s quality of life. This study investigates whether a new mobile application, the Stoma App, improves quality of life. And if personalized guidance, timed support, and peer contact offered as an in-app surplus makes a difference.MethodsA double-blind, randomized controlled trial was conducted between March 2021 and April 2023. Patients aged > 18 years undergoing ileostomy or colostomy surgery, in possession of a compatible smartphone were included. The intervention group received the full version of the app containing personalized and time guidance, peer support, and generic (non-personalized) stoma-related information. The control group received a restricted version with only generic information. Primary outcome was stoma quality of life. Secondary outcomes included psychological adaption, complications, re-admittance, reoperations, and length of hospital stay.ResultsThe intervention version of the app was used by 96 patients and the control version by 112 patients. After correction for confounding, the intervention group reported a significant 3.1-point improvement in stoma-related quality of life one month postoperatively (p = 0.038). On secondary outcomes, no significant improvements could be retrieved of the intervention group.ConclusionThe Stoma App improves the quality of life of stoma patients. Peer support and personalized guidance are of significant importance in building self-efficacy. It is to be recommended to implement Stoma app—freely available software qualifying as a medical device—in standard stoma care pathways for the benefits of both patients and healthcare providers.