Safety profile of a multimodal fail-safe model to minimize postoperative complications in oncologic colorectal resections-a cohort study.

BACKGROUND: Despite innovations in surgical techniques, major complications following colorectal surgery still lead to a significant morbidity and mortality. There is no standard protocol for perioperative management of patients with colorectal cancer. This study evaluates the effectiveness of a multimodal fail-safe model in minimizing severe surgical complications following colorectal resections. METHODS: We compared major complications in patients with colorectal cancers who underwent surgical resections with anastomosis during 2013-2014 (control group) with patients treated during 2015-2019 (fail-safe group). The fail-safe group had preoperative bowel preparation and a perioperative single dose of antibiotics, on-table bowel irrigation and early sigmoidoscopic assessment of anastomosis in rectal resections. A standard surgical technique for tension-free anastomosis was adapted in the fail-safe approach. The chi-square test measured relationships between categorical variables, t-test estimated the probability of differences, and the multivariate regression analysis determined the linear correlation among independent and dependent variables. RESULTS: A total of 924 patients underwent colorectal operations during the study period; however, 696 patients had surgical resections with primary anastomoses. There were 427 (61.4%) laparoscopic and 230 (33.0%) open operations, while 39 (5.6%) laparoscopic procedures were converted. Overall, the rate of major complications (Dindo-Clavien grade IIIb-V) significantly reduced from 22.6% for the control group to 9.8% for the fail-safe group (p < 0.0001). Major complications mainly occurred due to non-surgical reasons such as pneumonia, heart failure, or renal dysfunction. The rates of anastomotic leakage (AL) were 11.8% (22/186) and 3.7% (n = 19/510) for the control and fail-safe groups, respectively (p < 0.0001). CONCLUSION: We report an effective multimodal fail-safe protocol for colorectal cancer during the pre-, peri-, and postoperative period. The fail-safe model showed less postoperative complications even for low rectal anastomosis. This approach can be adapted as a structured protocol during the perioperative care of patients for colorectal surgery. TRIAL REGISTRATION: This study was registered in the German Clinical Trial Register (Study ID: DRKS00023804 ).

Intraoperative Colonic Irrigation for Low Rectal Resections With Primary Anastomosis: A Fail-Safe Surgical Model.

Aim: Regardless the technological developments in surgery, the anastomotic leakage (AL) rate of low rectal anastomosis remains high. Though various perioperative protocols have been tested to reduce the risk for AL, there is no standard peri-operative management approach in rectal surgery. We aim to assess the short-term outcome of a multidisciplinary approach to reduce the rates of ALs using a fail-safe-model using preoperative and intraoperative colonic irrigation in low rectal resections with primary anastomosis. Methods: Between January 2015 and December 2020, 92 patients received low rectal resections for rectal cancer with primary anastomosis and diverting ileostomy. All these patients received pre-operative mechanical bowel preparation (MBP) without antibiotics as well as intraoperative colonic irrigation. The intraoperative colonic irrigation was performed via the efferent loop of the ileostomy. All data were analyzed by SPSS for descriptive and inferential analyses. Results: In the study period, 1.987 colorectal surgical procedures were performed. This study reports AL in 3 (3.3%) of 92 recruited patients. Other postoperative complications (Dindo-Clavien I-IV) were reported in 25 patients (27.2%), which occurred mainly due to non-surgical reasons such as renal dysfunction and sepsis. According to the fail-safe model, AL was treated by endoscopic or re-do surgery. The median postoperative length of hospitalization was 8 days (4-45) days. Conclusion: This study validates the effectiveness of a multi-disciplinary fail-safe model with a pre-operative MBP and an intraoperative colonic irrigation in reducing AL rates. Intraoperative colonic irrigation is a feasible approach that lowers the AL rates by reducing fecal load and by decontamination of the colon and anastomotic region. Our study does not recommend a pre-operative administration of oral antibiotics for colorectal decontamination.

Quality of Life in Patients With Rectal Resections and End-to-End Primary Anastomosis Using a Standardized Perioperative Pathway.

Objectives: Lower rectal resection is associated with a high rate of postoperative complications and, therefore, adversely impacts the postoperative health-related quality of life (QoL). Though sporadically practiced in different centers, there is no standard perioperative protocol for the management of patients with rectal growths. The aim of this analysis is to evaluate the patient-reported outcomes after low rectal resections followed by an end-to-end-reconstruction and temporary covering ileostomy using a multidisciplinary fail-safe-concept. Methods: Between 2015 and 2020, we evaluated patient reported outcomes after open and laparoscopic rectal resections with end-to-end reconstruction with a primary straight anastomosis using a standardized perioperative pathway All patients with stoma were excluded from the study. The data for the QoL of patients was collected using the established Low Anterior Resection Syndrome (LARS)-score and the EORTC-C30 and CR-29 questionnaires at a single postoperative timepoint. Results: We recruited 78 stoma-free patients for this analysis. Of 78 patients included in the study, 87.2% were operated laparoscopically and the mean global health status was 67.95 points, while a major LARS was detected in 48 (61.5%) patients. No anastomotic leakage (AL) occurred within the study cohort. There was no significant change in the LARS-score or the global health status depending on the follow-up-period. Conclusion: This study shows that good QoL and functional outcomes with no AL are achievable following end-to-end straight anastomosis using a standardized perioperative surgical fail-safe protocol procedure.

The SERM raloxifene improves diaphyseal fracture healing in mice.

Although several studies reported that raloxifene treatment improves postmenopausal osteoporotic bone structure and reduces fracture risk, only a few animal and no human studies have examined its effects on the fracture healing process. Thus the aim of the present study was to determine, whether systemic application of the selective estrogen receptor modulator raloxifene promotes fracture healing compared to untreated control-, estrogen-deficient-, as well as estrogen-treated mice using a standardized femoral osteotomy model (n = 60 mice). Ten days after surgery, contact radiography and undecalcified histomorphometric analysis revealed that raloxifene administration significantly improved the early stage of fracture healing compared to all other groups. At day 20, raloxifene and estrogen treatment led to a significant increase in callus mineralization and trabecular thickness compared to control mice. µCT analyses revealed no evidence of complete bony bridging of the fracture site in any control-, nor estrogen-deficient mouse after 20 days, while all femoral fractures in the raloxifene and estrogen group already healed adequately at this time. These data indicate that raloxifene treatment significantly improves all phases of fracture healing at least in mice. Therefore, raloxifene could be a possible pharmaceutical to enhance fracture healing in women, without the known side effects of estrogen.

Clinical presentation and operative repair of Morgagni hernia.

OBJECTIVES: Morgagni hernia (MH) is an uncommon type of diaphragmatic hernia. This study aimed to summarize clinically relevant data with respect to MHs in adults. METHODS: We performed a retrospective chart review of patients who underwent surgical repair of foramen due to MH at our hospitals between 1996 and 2010. Data were collected on patient demographics, presenting symptoms, modes of diagnosis, surgical procedures, surgery outcomes, recurrence of hernia and follow-up of the patients. RESULTS: We included 36 patients with the mean age of 50.2 years. Of these 66.7% (n = 24) were female. Thirty-one patients had MH on the right side and 1 patient had bilateral MH. Most of the patients experienced abdominal symptoms. 72.2% of patients underwent laparotomy (n = 26, 72.2%), (n = 6, 16.7%) thoracotomy (n = 6, 16.7%), and a thoraco-abdominal approach (n = 4, 11.1%). Resection of the hernia sac and insertion of a mesh were not done in any patients. No recurrence occurred. CONCLUSIONS: We conclude that preoperative diagnosis and early diagnosis of MH by using laparotomy and thoracotomy is useful for safe and effective repair. Also we suggest that resection of the hernia sac and insertion of a mesh are not necessary.

BMP-7-induced ectopic bone formation and fracture healing is impaired by systemic NSAID application in C57BL/6-mice.

Nonsteroidal antiinflammatory drugs (NSAIDs) are known to potentially impair the fracture healing process. The aim of the present study was to determine if the impairment of bone healing by systemic NSAID application is, at least in part, due to an interaction of NSAIDs with the bone anabolic BMP-7 pathway. Therefore, we first analyzed fracture healing in control and diclofenac-treated mice, where we not only found a significant impairment of fracture healing due to diclofenac treatment as assessed by biomechanical testing and microCT imaging, but also found high coexpression of bone morphogenetic protein-7 (BMP-7) and cyclooxygenase-2 (COX-2) within the fracture callus of both groups. To experimentally address the possible interaction between BMP-7 and COX-2, we then induced ectopic bone formation in control (n = 10) and diclofenac-treated mice (n = 10) by application of BMP-7 (recombinant human OP-1, rhOP-1) into the hamstring muscles. After 20 days of treatment, each ectopic bone nodule was analyzed by contact-radiography, microCT, histology, and histomorphometry. Diclofenac application decreased the trabecular number and bone mass in the ectopic bone nodules significantly due to reduced osteoblast number and activity. These data demonstrate that the bone anabolic effect of BMP-7 and fracture healing is impaired by diclofenac application, and suggest that the potential negative impact of NSAIDs on fracture healing is, at least in part, due to interference with BMP-7 signaling.