Leveraging a nationwide infection surveillance program to implement a colorectal surgical site infection reduction bundle: a pragmatic, prospective, and multicenter cohort study.

BACKGROUND: Bundled interventions usually reduce surgical site infection (SSI) when implemented at single hospitals, but the feasibility of their implementation at the nationwide level and their clinical results are not well established. MATERIALS AND METHODS: Pragmatic interventional study to analyze the implementation and outcomes of a colorectal surgery care bundle within a nationwide quality improvement program. The bundle consisted of antibiotic prophylaxis, oral antibiotic prophylaxis (OAP), mechanical bowel preparation, laparoscopy, normothermia, and a wound retractor. Control group (CG) and Intervention group (IG) were compared. Overall SSI, superficial (S-SSI), deep (D-SSI), and organ/space (O/S-SSI) rates were analyzed. Secondary endpoints included microbiology, 30-day mortality, and length of hospital stay. RESULTS: A total of 37 849 procedures were included, 19 655 in the CG and 18 194 in the IG. In all, 5462 SSIs (14.43%) were detected: 1767 S-SSI (4.67%), 847 D-SSI (2.24%), and 2838 O/S-SSI (7.5%). Overall SSI fell from 18.38% (CG) to 10.17% (IG), odds ratio (OR) of 0.503 [0.473-0.524]. O/S-SSI rates were 9.15% (CG) and 5.72% (IG), OR of 0.602 [0.556-0.652]. The overall SSI rate was 16.71% when no measure was applied and 6.23% when all six were used. Bundle implementation reduced the probability of overall SSI (OR: 0.331; CI 95 : 0.242-0.453), and also O/S-SSI rate (OR: 0.643; CI 95 : 0.416-0.919). In the univariate analysis, all measures except normothermia were associated with a reduction in overall SSI, while only laparoscopy, OAP, and mechanical bowel preparation were related to a decrease in O/S-SSI. Laparoscopy, wound retractor, and OAP decreased overall SSI and O/S-SSI in the multivariate analysis. CONCLUSIONS: In this cohort study, the application of a specific care bundle within a nationwide nosocomial infection surveillance system proved feasible and resulted in a significant reduction in overall and O/S-SSI rates in the elective colon and rectal surgery. The OR for SSI fell between 1.5 and 3 times after the implementation of the bundle.

Surviving rectal cancer at the cost of a colostomy: global survey of long-term health-related quality of life in 10 countries.

BACKGROUND: Colorectal cancer management may require an ostomy formation; however, a stoma may negatively impact health-related quality of life (HRQoL). This study aimed to compare generic and stoma-specific HRQoL in patients with a permanent colostomy after rectal cancer across different countries. METHOD: A cross-sectional cohorts of patients with a colostomy after rectal cancer in Denmark, Sweden, Spain, the Netherlands, China, Portugal, Australia, Lithuania, Egypt, and Israel were invited to complete questionnaires regarding demographic and socioeconomic factors along with the Colostomy Impact (CI) score, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and five anchor questions assessing colostomy impact on HRQoL. The background characteristics of the cohorts from each country were compared and generic HRQoL was measured with the EORTC QLQ-C30 presented for the total cohort. Results were compared with normative data of reference European populations. The predictors of reduced HRQoL were investigated by multivariable logistic regression, including demographic and socioeconomic factors and stoma-related problems. RESULTS: A total of 2557 patients were included. Response rates varied between 51-93 per cent. Mean time from stoma creation was 2.5-6.2 (range 1.1-39.2) years. A total of 25.8 per cent of patients reported that their colostomy impairs their HRQoL 'some'/'a lot'. This group had significantly unfavourable scores across all EORTC subscales compared with patients reporting 'no'/'a little' impaired HRQoL. Generic HRQoL differed significantly between countries, but resembled the HRQoL of reference populations. Multivariable logistic regression showed that stoma dysfunction, including high CI score (OR 3.32), financial burden from the stoma (OR 1.98), unemployment (OR 2.74), being single/widowed (OR 1.35) and young age (OR 1.01 per year) predicted reduced stoma-related HRQoL. CONCLUSION: Overall HRQoL is preserved in patients with a colostomy after rectal cancer, but a quarter of the patients interviewed reported impaired HRQoL. Differences among several countries were reported and socioeconomic factors correlated with reduced quality of life.

Life with a stoma across five European countries-a cross-sectional study on long-term rectal cancer survivors.

PURPOSE: Stoma-related problems are known to be important to patients and potentially affect everyday life. The prevalence of stoma-related problems in rectal cancer survivors remains undetermined. This study aimed to examine aspects of life with a long-term stoma, stoma management, and stoma-related problems and explore the impact of stoma-related problems on daily life. METHODS: In total, 2262 patients from 5 European countries completed a multidimensional survey. Stoma-related problems were assessed using the Colostomy Impact score. Multivariable regression analysis, after adjusting for potential confounding factors, provided odds ratio (OR) and 95% confidence intervals (CI) for stoma-related problems' association with restrictions in daily life. RESULTS: The 2262 rectal cancer survivors completed the questionnaire at a median of 5.4 years (interquartile range 3.8-7.6) after stoma formation. In the total sample, leakage (58%) and troublesome odour (55%) were most prevalent followed by skin problems (27%) and pain (21%). Stoma-related problems were more prevalent in patients with parastomal bulging. A total of 431 (19%) reported feeling restricted in daily activities in life with a stoma. Leakage, odour, skin problems, stool consistency, and frequent appliance changes were significantly associated with restrictions in daily life. The highest risk of experiencing restrictions was seen for patients having odour (OR 2.74 [95% CI: 1.99-3.78]) more than once a week and skin problems (OR 1.77 [95% CI: 1.38-2.27]). CONCLUSION: In this large cohort with rectal cancer, stoma-related problems were highly prevalent and impacted daily life. Supportive care strategies should entail outreach to patients with a long-term stoma.

A standardized stepwise approach to minimally invasive ileocolic anastomosis: Tips and tricks for laparoscopic and robotic surgery.

AIM: Intracorporeal anastomosis has been associated with earlier recovery of postoperative bowel function, shorter length of stay and lower surgical site infection rates. The aim of this work is to describe a step-by-step standardized technique for intracorporeal ileocolic and ileosigmoid anastomosis suitable for laparoscopic and robotic colectomy. METHOD: Each step of the technique is illustrated using a composite collection of three operative patient videos. Two procedures were performed robotically and one was laparoscopic. Tips are provided to construct a two-layer anastomosis (both posteriorly and anteriorly). The procedures are presented in stepwise fashion, discussing the advantages and feasibility of the technique. RESULTS: The standardized technique described herein was used in three patients for this report, of whom two underwent right colectomy and one subtotal colectomy for cancer. The median operating time was 255 (206-333) min. There were no intraoperative complications. No major postoperative complications or 30-day readmissions occurred. The median length of stay was 4 (3-5) days. CONCLUSION: The described technique of a two-layer anastomosis can be used with any available minimally invasive approach. It is safe and feasible. Using a standardized approach, the technique can be easily taught and mastered, optimizing operating times and reducing adverse events.

Robotic abdominal resection of tailgut cysts - A technical note with step-by-step description.

AIM: Here, we describe a step-by-step standardized technique for tailgut cyst resection using a single-docking robotic approach. METHOD: Each step of the technique is illustrated using a composite collection of four operative patient videos to demonstrate the advantages and feasibility of this technique. The robot platform utilised is Da Vinci Xi. RESULTS: Five female patients have undergone this operation in our unit. The size of tumours ranged from 12 to 45 mm. Median operating time was 100 min (range 90-150). Mean blood loss in all the patients was less than 50 ml. There were no major intraoperative complications. One patient had a postoperative presacral collection which required radiological drainage. Length of stay in all patients was one day. CONCLUSIONS: This technique using a single-docking robotic approach appears safe and feasible. The robotic approach results in improved dexterity and more accurate dissection, better retraction and excellent vision which improves the ease of operating in the pelvis. Therefore, this approach can be replicated for use in a wide variety of patients with tailgut cysts.

Upfront surgery versus self-expanding metallic stent as bridge to surgery in left-sided colonic cancer obstruction: A multicenter observational study.

BACKGROUND: Oncological outcomes of self-expanding metallic stent used as a bridge to surgery in potential curative patients with left-sided colonic cancer obstruction remain unclear. The aim of this study was to investigate perioperative and mid-term oncological outcomes of 2 of the currently most commonly performed treatments in left-sided colonic cancer obstruction. METHODS: This is a retrospective multicenter study including patients with left-sided colonic cancer obstruction treated with curative intent between 2013 and 2017. The presence of metastasis at diagnosis was an exclusion criterion. The primary outcome was to evaluate the noninferiority, in terms of overall survival, of bridge to surgery strategy compared with emergency colonic resection. The secondary outcomes were perioperative morbimortality, disease free survival, local recurrence, and distant recurrence. RESULTS: A total of 564 patients were included, 320 in the emergency colonic resection group and 244 in the bridge to surgery group. Twenty-seven patients of the bridge-to-surgery group needed urgent operation. Postoperative morbidity rates were statistically higher in the emergency colonic resection group (odds ratio [95% confidence interval] 0.37 [0.24-0.55], P < .001). There was no difference in 90-day mortality between groups (odds ratio [95% confidence interval] 0.85 [0.36-1.99], P = .702). The median follow-up was 3.80 years (2.29-4.92). The results show the noninferiority of bridge to surgery versus emergency colonic resection in terms of overall survival (hazard ratio [95% confidence interval) 0.78 [0.56-1.07], P = .127). There were no differences in disease free survival, distant recurrence, and local recurrence rates between bridge to surgery and emergency colonic resection groups. CONCLUSION: Self-expanding metallic stent as bridge to surgery might not lead to a negative impact on the long-term prognosis of the tumor compared with emergency colonic resection in expert hands and selected patients.

Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2).

AIM: Surgical site infections (SSIs) are common after colonic surgery. SSIs can cause relevant morbidity and increase costs of care. Preoperative oral antibiotics can reduce the incidence of SSIs after resection of the colon, but the role of mechanical bowel preparation (MBP) is debated. This study aims to assess the impact of a combined regimen of oral antibiotics and MBP on SSIs after colonic surgery. METHODS: An international, multicentre, pragmatic, adaptive, parallel-group, randomized controlled trial will be conducted across Europe. Adult patients scheduled to undergo elective colonic resection will be assessed for inclusion. Patients will be randomized into one of two treatment arms: (1) preoperative oral antibiotics without MBP (control); (2) preoperative oral antibiotics with MBP (experimental). All patients will receive intravenous antibiotics at anaesthetic induction. The primary aim will be 30-day SSI, assessed by a blinded nurse. Additional end-points include safety, morbidity and mortality, satisfaction with the preparation, time to return of bowel function, time to complete recovery and time to discharge, long-term results. Analyses will be performed with a modified intention-to-treat approach. Interim analyses are planned. DISCUSSION: This will be the first randomized clinical trial to assess the efficacy and safety of preoperative oral antibiotics plus MBP versus preoperative oral antibiotics only, before colonic surgery. The knowledge obtained could help to establish the ideal preparation for patients scheduled to undergo resection of the colon. Full protocol NCT04161599.

Translation and international validation of the Colostomy Impact score.

AIM: Optimal oncological resection in cancers of the lower rectum often requires a permanent colostomy. However, in some patients a colostomy may have a negative impact on health-related quality of life (HRQoL). The Colostomy Impact (CI) score is a simple questionnaire that identifies patients with stoma dysfunction that impairs HRQoL by dividing patients into 'minor' and 'major' CI groups. This aim of this study is to evaluate construct and discriminative validity, sensitivity, specificity and reliability of the CI score internationally, making it applicable for screening and identification of patients with stoma-related impaired HRQoL. METHOD: The CI score was translated in agreement with WHO recommendations. Cross-sectional cohorts of rectal cancer survivors with a colostomy in Australia, China, Denmark, the Netherlands, Portugal, Spain and Sweden were asked to complete the CI score, the European Organization for Research and Treatment of Cancer (EORTC) quality of life 30-item core questionnaire, the stoma-specific items of the EORTC quality of life 29-item colorectal-specific questionnaire and five anchor questions assessing the impact of colostomy on HRQoL. RESULTS: A total of 2470 patients participated (response rate 51%-93%). CI scores were significantly higher in patients reporting reduced HRQoL due to their colostomy than in patients reporting no reduction. Differences in EORTC scale scores between patients with minor and major CI were significant and clinically relevant. Sensitivity was high regarding dissatisfaction with a colostomy. Regarding evaluation of discriminative validity, the CI score relevantly identified groups with differences in HRQoL. The CI score proved reliable, with equal CI scores between test and retest and an intraclass correlation coefficient in the moderate to excellent range. CONCLUSION: The CI score is internationally valid and reliable. We encourage its use in clinical practice to identify patients with stoma dysfunction who require further attention.

Incidence, features, outcome and impact on health system of de-novo abdominal surgical diseases in patients admitted with COVID-19.

OBJECTIVE: to assess the epidemiology and features of de novo surgical diseases in patients admitted with COVID-19, and their impact on patients and healthcare system. SUMMARY BACKGROUND DATA: Gastrointestinal involvement has been described in COVID-19; however, no clear figures of incidence, epidemiology and economic impact exist for de-novo surgical diseases in hospitalized patients. METHODS: This is a prospective study including all patients admitted with confirmed SARS-CoV-2 rT-PCR, between 1 March and 15 May 2020 at two Tertiary Hospitals. Patients with known surgical disease at admission were excluded. Sub-analyses were performed with a consecutive group of COVID-19 patients admitted during the study period, who did not require surgical consultation. RESULTS: Ten out of 3089 COVID-19 positive patients (0.32%) required surgical consultation. Among those admitted in intensive care unit (ICU) incidence was 1.9%. Mortality was 40% in patients requiring immediate surgery and 20% in those suitable for conservative management. The overall median length of stay (LOS) of patients admitted to ICU was longer in those requiring surgical consultation compared with those who did not (51.5 vs 25 days, p = 0.0042). Patients requiring surgical consultation and treatment for de-novo surgical disease had longer median ICU-LOS (31.5 vs 12 days, p = 0.0004). A median of two post-surgical complications were registered for each patient undergoing surgery. Complication-associated costs were as high as 38,962 USD per patient. CONCLUSIONS: Incidence of de-novo surgical diseases is low in COVID-19, but it is associated with significant morbidity and mortality. Future studies should elucidate the mechanism underlying the condition and identify strategies to prevent the need for surgery.

Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study.

OBJECTIVE: To prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events. DESIGN: International, multicentre cohort study. SETTING: 18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America. PARTICIPANTS: The cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres. MAIN OUTCOME MEASURES: Intraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications. RESULTS: Of 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0.99 (95% confidence interval 0.69 to 1.42); grade II versus grade 0, 1.39 (0.97 to 2.00); grade III versus grade 0, 2.62 (1.31 to 5.26); and grade IV versus grade 0, 3.81 (1.19 to 12.2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0.76 (95% confidence interval 0.59 to 0.91) in the survey (response rate 83%). CONCLUSIONS: ClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03009929.

Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial.

BACKGROUND: Previous studies have found that mechanical bowel preparation with oral antibiotics can reduce the incidence of surgical-site infections, but no randomised controlled trial has assessed oral antibiotics alone without mechanical bowel preparation. The aim of this study was to determine whether prophylaxis with oral antibiotics the day before elective colon surgery affects the incidence of postoperative surgical-site infections. METHODS: In this multicentre, pragmatic, randomised controlled trial (ORALEV), patients undergoing colon surgery were recruited from five major hospitals in Spain and 47 colorectal surgeons at these hospitals participated. Patients were eligible for inclusion if they were diagnosed with neoplasia or diverticular disease and if a partial colon resection or total colectomy was indicated. Participants were randomly assigned (1:1) using online randomisation tables to either administration of oral antibiotics the day before surgery (experimental group) or no administration of oral antibiotics before surgery (control group). For the experimental group, ciprofloxacin 750 mg was given every 12 h (two doses at 1200 h and 0000 h) and metronidazole 250 mg every 8 h (three doses at 1200 h, 1800 h, and 0000 h) the day before surgery. All patients were given intravenous cefuroxime 1·5 g and metronidazole 1 g at the time of anaesthetic induction. The primary outcome was incidence of surgical-site infections. Patients were followed up for 1 month after surgery and all postsurgical complications were registered. This study was registered with EudraCT, 2014-002345-21, and ClinicalTrials.gov, NCT02505581, and is closed to accrual. FINDINGS: Between May 2, 2015, and April 15, 2017, we assessed 582 patients for eligibility, of whom 565 were eligible and randomly assigned to receive either no oral antibiotics (n=282) or oral antibiotics (n=282) before surgery. 13 participants in the control group and 16 in the experimental group were subsequently excluded; 269 participants in the control group and 267 in the experimental group received their assigned intervention. The incidence of surgical-site infections in the control group (30 [11%] of 269) was significantly higher than in the experimental group (13 [5%] of 267; χ2 test p=0·013). Oral antibiotics were associated with a significant reduction in the risk of surgical-site infections compared with no oral antibiotics (odds ratio 0·41, 95% CI 0·20-0·80; p=0·008). More complications (including surgical-site infections) were observed in the control group than in the experimental group (76 [28%] vs 51 [19%]; p=0·017), although there was no difference in severity as assessed by Clavien-Dindo score. No differences were noted between groups in terms of local complications, surgical complications, or medical complications that were not related to septic complications. INTERPRETATION: The administration of oral antibiotics as prophylaxis the day before colon surgery significantly reduces the incidence of surgical-site infections without mechanical bowel preparation and should be routinely adopted before elective colon surgery. FUNDING: Fundación Asociación Española de Coloproctología.