Influence of Neoadjuvant Therapy on Success of Endoscopic Vacuum Therapy in Anastomotic Leakage after Rectal Resection Because of Rectal Cancer.

Background: For locally advanced rectal cancer, neoadjuvant therapy (NT) is an established element of therapy. Endoscopic vacuum therapy (EVT) has been a relevant treatment option for anastomotic leakage after rectal resection since 2008. The aim was to evaluate the influence of NT on the duration and success of EVT in anastomotic leakage after rectal resection for rectal cancer. Methods: This was a monocentric, retrospective cohort study including patients who underwent rectal resection with primary anastomosis because of histologically proven carcinoma of the rectum in the Department for General and Visceral Surgery of Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin over a period of ten years (2012 to 2022). Results: Overall, 243 patients were included, of which 47 patients (19.3%) suffered from anastomotic leakage grade B with consecutive EVT. A total of 29 (61.7%) patients received NT and 18 patients (38.3%) did not. The median duration of EVT until the removal of the sponge did not differ between patients with and without NT: 24.0 days (95% CI 6.44-41.56) versus 20.0 days (95% CI 17.03-22.97); p = 0.273. The median duration from insertion of EVT until complete healing was 74.0 days with NT (95% CI 10.07-137.93) versus 62.0 days without NT (95% CI 45.99-78.01); p = 0.490. Treatment failure-including early persistence and late onset of recurrent anastomotic leakage-was evident in 27.6% of patients with NT versus 27.8% without NT; p = 0.989. Ostomy was reversed in 19 patients (79.2%) with NT compared to 11 patients (68.8%) without NT; p = 0.456. Overall, continuity was restored in 75% of patients in the long term after EVT. Conclusion: This trial comprised-to our knowledge-the largest study cohort to analyze the outcome of EVT in anastomotic leakage after rectal resection for rectal cancer. We conclude that neoadjuvant therapy neither prolongs EVT nor the time to healing from anastomotic leakage. The rates of treatment failure of EVT and permanent ostomy were not higher when neoadjuvant therapy was used.

Standardized digital solution with surgical procedure manager (SPM®)-an opportunity for maximizing patient safety and efficiency in ileostomy reversal?

Background: Standardization and digitalization are getting more and more essential in surgery. Surgical procedure manager (SPM®) is a freestanding computer serving as a digital supporter in the operating room. SPM® navigates step-by-step through surgery by providing a checklist for each individual step. Methods: This was a single center, retrospective study at the Department for General and Visceral Surgery at Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin. Patients who underwent ileostomy reversal without SPM® in the period of January 2017 until December 2017 were compared to patients who were operated with SPM® in the period of June 2018 until July 2020. Explorative analysis and multiple logistic regression were performed. Results: Overall, 214 patients underwent ileostomy reversal: 95 patients without SPM® vs. 119 patients with SPM®. Ileostomy reversal was performed by head of department/attendings in 34.1%, by fellows in 28.5% and by residents in 37.4%; p = 0.91. Postoperative intraabdominal abscess emerged more often in patients without SPM®: ten (10.5%) patients vs. four (3.4%) patients; p = 0.035. Multiple logistic regression showed a risk reduction for intraabdominal abscess {Odds ratio (OR) 0.19 [95% confidence interval (CI) 0.05-0.71]; p = 0.014} and for bowel perforation [OR 0.09 (95% CI 0.01-0.93); p = 0.043] in the group with use of SPM® in ileostomy reversal. Conclusions: SPM® may reduce postoperative complications in ileostomy reversal such as intraabdominal abscess and bowel perforation. SPM® may contribute to patient safety.

Feasibility of Novel Software-Based Perfusion Indicators for the Ileal J-Pouch-On the Path towards Objective and Quantifiable Intraoperative Perfusion Assessment with Indocyanine Green Near-Infrared Fluorescence.

BACKGROUND: In restorative proctocolectomy with ileal J-pouch, perfusion assessment is vital to prevent complications such as anastomotic leak (AL). Indocyanine green near-infrared fluorescence (ICG-NIRF) is gaining popularity, while its interpretation and relevance remain subjective. This study aimed to evaluate a standardized ICG-NIRF imaging protocol combined with a novel, software-based assessment to detect areas of impaired perfusion and a possible correlation with AL of the pouch. METHODS: In this prospective study, patients undergoing ileal J-pouch for ulcerative colitis at an inflammatory bowel disease (IBD) referral center were included. Intraoperatively, strictly standardized ICG-NIRF visualization was performed and video-recorded. Postoperatively, a specific software was utilized to determine the change in fluorescence intensity per second (i/s) for systematic regions of interest, generating perfusion-time curves and a pixel-to-pixel map. These were analysed in detail and correlated with clinical outcome (primary end point: AL within 30 days; clearly defined and screened for by pouchoscopy). RESULTS: Four out of 18 included patients developed AL of the ileal pouch-anal anastomosis (IPAA). In the AL group, the perfusion curves on the area adjacent to the IPAA (pouch apex) displayed considerably lower ingress/inflow (median = 1.7; range = 8.5; interquartile-range = 3.8 i/s) and egress/outflow (median = -0.1; range = 0.7; interquartile-range = 0.5 i/s) values than in the non-AL group (ingress: median = 4.3; range = 10.3; interquartile-range = 4.0 i/s); egress: median = (-1.1); range = 3.9; interquartile range = 1.0 i/s). This was confirmed by further novel parameters of pouch perfusion (maximum ingress; maximum egress) and pixel-to-pixel analysis. CONCLUSIONS: This study presents the feasibility of a novel methodology to precisely assess pouch perfusion with ICG-NIRF, identifying comparable, quantifiable, and objective parameters to potentially detect perfusion-associated complications in surgery in real-time.

Perfusion Visualization during Ileal J-Pouch Formation-A Proposal for the Standardization of Intraoperative Imaging with Indocyanine Green Near-Infrared Fluorescence and a Postoperative Follow-Up in IBD Surgery.

BACKGROUND: An anastomotic leak (AL) after a restorative proctocolectomy and an ileal J-pouch increases morbidity and the risk of pouch failure. Thus, a perfusion assessment during J-pouch formation is crucial. While indocyanine green near-infrared fluorescence (ICG-NIRF) has shown potential to reduce ALs, its suitability in a restorative proctocolectomy remains unclear. We aimed to develop a standardized approach for investigating ICG-NIRF and ALs in pouch surgery. METHODS: Patients undergoing a restorative proctocolectomy with an ileal J-pouch for ulcerative colitis at an IBD-referral-center were included in a prospective study in which an AL within 30 postoperative days was the primary outcome. Intraoperatively, standardized perfusion visualization with ICG-NIRF was performed and video recorded for postoperative analysis at three time points. Quantitative clinical and technical variables (secondary outcome) were correlated with the primary outcome by descriptive analysis and logistic regression. A novel definition and grading of AL of the J-pouch was applied. A postoperative pouchoscopy was routinely performed to screen for AL. RESULTS: Intraoperative ICG-NIRF-visualization and its postoperative visual analysis in 25 patients did not indicate an AL. The anastomotic site after pouch formation appeared completely fluorescent with a strong fluorescence signal (category 2) in all cases of ALs (4 of 25). Anastomotic site was not changed. ICG-NIRF visualization was reproducible and standardized. Logistic regression identified a two-stage approach vs. a three-stage approach (Odds ratio (OR) = 20.00, 95% confidence interval [CI] = 1.37-580.18, p = 0.029) as a risk factor for ALs. CONCLUSION: We present a standardized, comparable approach of ICG-NIRF visualization in pouch surgery. Our data indicate that the visual interpretation of ICG-NIRF alone may not detect ALs of the pouch in all cases-quantifiable, objective methods of interpretation may be required in the future.

Is There an Association between Intra-Operative Detection of Pathogens in Subcutaneous Tissue and Surgical Site Infections? Results from a Prospective Study.

Background: Surgical site infections (SSIs) are a common complication in visceral surgery. Pathogens causing SSIs vary depending on the type of surgery. Patients and Methods: Within the scope of the Reduction of Postoperative Wound Infections by Antiseptica (RECIPE) trial we analyzed the pathogens cultured in intra-operative, subcutaneous swabs and in swabs from SSI in a single-center, prospective, randomized controlled study. Definition of SSI complied with the criteria of the U.S. Centers for Disease Control and Prevention (CDC). Results: The overall rate of SSI was 28.2% in 393 patients. Colorectal surgery was performed in 68.2% of elective laparotomies. Pathogens were more often detected in intra-operative subcutaneous swabs in patients who developed SSIs than in patients who did not develop SSIs (64.4% vs. 38.0%; p < 0.001). Enterococci were found in 29.1% of intra-operative swabs in patients with SSIs, followed by Escherichia coli in 15.5%. A higher rate of Enterococcus faecium was found in patients with anemia versus those without anemia (9.2% vs. 2.3%; p = 0.006) and in patients who smoked versus those who did not (11.8% vs. 3.6%; p = 0.008). A positive subcutaneous swab (odds ratio [OR], 2.51; 95% confidence interval [CI], 1.47-4.29; p = 0.001), pre-operative anemia (OR, 1.84; 95% CI, 1.08-3.13; p = 0.016), and renal insufficiency (OR, 2.15; 95% CI, 1.01-4.59; p = 0.048) were risk factors for SSIs. Conclusions: There is an association between the intra-operative detection of pathogens in subcutaneous tissue and the development of SSIs in visceral surgery. The most prevalent pathogens causing SSIs were enterococci and Escherichia coli. More efforts are justified to reduce subcutaneous colonization with pathogens, for example by using intra-operative wound irrigation with polyhexanide solution. This trial is registered at www.ClinicalTrials.gov (ID: NCT04055233).

The impact of surgical site infection-a cost analysis.

PURPOSE: Surgical site infection (SSI) occurs in up to 25% of patients after elective laparotomy. We aimed to determine the effect of SSI on healthcare costs and patients' quality of life. METHODS: In this post hoc analysis based on the RECIPE trial, we studied a 30-day postoperative outcome of SSI in a single-center, prospective randomized controlled trial comparing subcutaneous wound irrigation with 0.04% polyhexanide to 0.9% saline after elective laparotomy. Total medical costs were analyzed accurately per patient with the tool of our corporate controlling team which is based on diagnosis-related groups in Germany. RESULTS: Between November 2015 and May 2018, 456 patients were recruited. The overall rate of SSI was 28.2%. Overall costs of inpatient treatment were higher in the group with SSI: median 16.685 €; 19.703 USD (IQR 21.638 €; 25.552 USD) vs. median 11.235 €; 13.276 USD (IQR 11.564 €; 13.656 USD); p < 0.001. There was a difference in surgery costs (median 6.664 €; 7.870 USD with SSI vs. median 5.040 €; 5.952 USD without SSI; p = 0.001) and costs on the surgical ward (median 8.404 €; 9.924 USD with SSI vs. median 4.690 €; 5.538 USD without SSI; p < 0.001). Patients with SSI were less satisfied with the cosmetic result (4.3% vs. 16.2%; p < 0.001). Overall costs for patients who were irrigated with saline were median 12.056 €; 14.237 USD vs. median 12.793 €; 15.107 USD in the polyhexanide group (p = 0.52). CONCLUSION: SSI after elective laparotomy increased hospital costs substantially. This is an additional reason why the prevention of SSI is important. Overall costs for intraoperative wound irrigation with saline were comparable with polyhexanide.

Validation of the German Classification of Diverticular Disease (VADIS)-a prospective bicentric observational study.

PURPOSE: The German Classification of Diverticular Disease was introduced a few years ago. The aim of this study was to determine whether Classification of Diverticular Disease enables an exact stratification of different types of diverticular disease in terms of course and treatment. METHODS: This was a prospective, bicentric observational trial. Patients aged ≥ 18 years with diverticular disease were prospectively included. The primary endpoint was the rate of recurrence within 2 year follow-up. Secondary outcome measures were Gastrointestinal Quality of Life Index, Quality of life measured by SF-36, frequency of gastrointestinal complaints, and postoperative complications. RESULTS: A total of 172 patients were included. After conservative management, 40% of patients required surgery for recurrence in type 1b vs. 80% in type 2a/b (p = 0.04). Sixty percent of patients with type 2a (micro-abscess) were in need of surgery for recurrence vs. 100% of patients with type 2b (macro-abscess) (p = 0.11). Patients with type 2a reached 123 ± 15 points in the Gastrointestinal Quality of Life Index compared with 111 ± 14 in type 2b (p = 0.05) and higher scores in the "Mental Component Summary" scale of SF-36 (52 ± 10 vs. 43 ± 13; p = 0.04). Patients with recurrent diverticulitis without complications (type 3b) had less often painful constipation (30% vs. 73%; p = 0.006) when they were operated compared with conservative treatment. CONCLUSION: Differentiation into type 2a and 2b based on abscess size seems reasonable as patients with type 2b required surgery while patients with type 2a may be treated conservatively. Sigmoid colectomy in patients with type 3b seems to have gastrointestinal complaints during long-term follow-up. TRIAL REGISTRATION: https://www.drks.de ID: DRKS00005576.

Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline. BACKGROUND: SSI is a common complication after gastrointestinal surgery. To date, there is a lack of evidence whether subcutaneous wound irrigation is beneficial in terms of reduction of SSI. METHODS: The RECIPE trial was an investigator initiated single-center, single-blind prospective, randomized controlled trial with 2 parallel treatment groups, comparing wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution in elective laparotomies. Primary endpoint was the rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria. RESULTS: Between February 02, 2015, and May 23, 2018, 456 patients were randomly assigned to saline (n = 228) or polyhexanide (n = 228). Final cohort for analysis comprised 393 patients (202 in the saline and 191 in the polyhexanide group). Overall rate of SSI was 28.2%, n = 111. Simple analysis with cross tabulation revealed that significantly fewer SSIs occurred in the polyhexanide group: n = 70 (34.7%) versus n = 41 (21.5%); P = 0.004. In a multiple logistic regression model the factor wound irrigation with polyhexanide [odds ratio (OR) 0.44; 95% confidence interval (CI) 0.27-0.72; P = 0.001) was associated with risk reduction of SSI. Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI. CONCLUSIONS: Intraoperative subcutaneous wound irrigation with antiseptic 0.04% polyhexanide solution is effective in reducing SSI after elective laparotomies.