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Loop ileostomy versus total colectomy as surgical treatment for Clostridium difficile-associated disease: An Eastern Association for the Surgery of Trauma multicenter trial.

ABSTRACT: OBJECTIVES:The mortality of patients with Clostridium difficile-associated disease (CDAD) requiring surgery continues to be very high. Loop ileostomy (LI) was introduced as an alternative procedure to total colectomy (TC) for CDAD by a single-center study. To date, no reproducible results have been published. The objective of this study was to compare these two procedures in a multicentric approach to help the surgeon decide what procedure is best suited for the patient in need. METHODS:This was a retrospective multicenter study conducted under the sponsorship of the Eastern Association for the Surgery of Trauma. Demographics, medical history, clinical presentation, APACHE score, and outcomes were collected. We used the Research Electronic Data Capture tool to store the data. Mann-Whitney (continuous data) and Fisher exact (categorical data) were used to compare TC with LI. Logistic regression was performed to determine predictors of mortality. A propensity score analysis was done to control for potential confounders and determine adjusted mortality rates by procedure type. RESULTS:We collected data from 10 centers of patients who presented with CDAD requiring surgery between July 1, 2010 and July 30, 2014. Two patients died during the surgical procedure, leaving 98 individuals in the study. The overall mortality was 32%, and 75% had postoperative complications. Median age was 64.5 years; 59% were male. Concerning preoperative patient conditions, 54% were on pressors, 47% had renal failure, and 36% had respiratory failure. When comparing TC and LI, there was no statistical difference regarding these conditions. Univariate preprocedure predictors of mortality were age, lactate, timing of operation, vasopressor use, and acute renal failure. There was no statistical difference between the APACHE score of patients undergoing either procedure (TC, 22 vs LI, 16). Adjusted mortality (controlled for preprocedure confounders) was significantly lower in the LI group (17.2% vs 39.7%; p = 0.002). CONCLUSIONS:This is the first multicenter study comparing TC with LI for the treatment of CDAD. In this study, LI carried less mortality than TC. In patients without contraindications, LI should be considered for the surgical treatment of CDAD. LEVEL OF EVIDENCE:Therapeutic study, level III.

SUBMITTER: Ferrada P

PROVIDER: S-EPMC5998809 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Loop ileostomy versus total colectomy as surgical treatment for Clostridium difficile-associated disease: An Eastern Association for the Surgery of Trauma multicenter trial.

Ferrada Paula P Callcut Rachael R Zielinski Martin D MD Bruns Brandon B Yeh Daniel Dante DD Zakrison Tanya L TL Meizoso Jonathan P JP Sarani Babak B Catalano Richard D RD Kim Peter P Plant Valerie V Pasley Amelia A Dultz Linda A LA Choudhry Asad J AJ Haut Elliott R ER

The journal of trauma and acute care surgery 20170701 1

<h4>Objectives</h4>The mortality of patients with Clostridium difficile-associated disease (CDAD) requiring surgery continues to be very high. Loop ileostomy (LI) was introduced as an alternative procedure to total colectomy (TC) for CDAD by a single-center study. To date, no reproducible results have been published. The objective of this study was to compare these two procedures in a multicentric approach to help the surgeon decide what procedure is best suited for the patient in need.<h4>Metho ...[more]

PMID: 28426557

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Project description:ImportanceDiverting loop ileostomy and colonic lavage has generated much interest since it was first reported as a potential alternative to total abdominal colectomy for treating Clostridium difficile colitis in 2011. To our knowledge, few studies have validated the benefit reported in the initial description, and the association of this new approach with practice patterns has not been described.ObjectiveTo examine the national adoption pattern and outcomes of diverting loop ileostomy vs total abdominal colectomy as treatment for fulminant C difficile colitis.Design, setting, and participantsThis retrospective cohort study used data from hospitals participating in the National Inpatient Sample database across the United States from January 2011 to September 2015 and included 3021 adult patients who underwent surgery for C difficile colitis during the study period, comprising 2408 subtotal colectomies and 613 loop ileostomies. The data were analyzed between November 2018 and April 2019.ExposuresLoop ileostomy as surgery of choice.Main outcomes and measuresIn-hospital mortality.ResultsOf 2408 participants, 1416 (58.8%) were women, 1781 (78.4%) were white, and 627 (21.6%) were individuals of color and the mean (SD) age was 68.2 (14.8) years. During the overall study period, 613 patients (20.28%) underwent diverting loop ileostomy without total abdominal colectomy. The annual proportion of patients undergoing only diversion increased from 11.16% in 2011 to 25.30% in 2015. Significantly more loop ileostomies were performed within the first day of hospitalization, in contrast to subtotal colectomies (23.31% vs 12.21%; P < .01). There was no significant difference in in-hospital mortality rates between the 2 groups (25.98% vs 31.18%; P = .28).Conclusions and relevanceThis study demonstrates the adoption of diverting loop ileostomy to treat C difficile colitis across the United States. While fulminant C difficile colitis remains a condition with high mortality rates, no significant difference in this outcome was observed between loop ileostomy and total abdominal colectomy. Loop ileostomy may represent a viable surgical alternative to total abdominal colectomy, although the grounds for selection of treatment need to be clarified.

Project description:BackgroundThe epidemiology of Clostridium difficile-associated infection (CDI) has changed, and it is evident that susceptibility is related not only to exposures and bacterial potency, but host factors as well. Several small studies have suggested that CDI after trauma is associated with a different patient phenotype. The purpose of this study was to examine and describe the epidemiologic factors associated with C. difficile in blunt trauma patients without traumatic brain injury using the Trauma-Related Database as a part of the "Inflammation and Host Response to Injury" (Glue Grant) and the University of Florida Integrated Data Repository.MethodsPreviously recorded baseline characteristics, clinical data, and outcomes were compared between groups (67 C. difficile and 384 uncomplicated, 813 intermediate, and 761 complicated non-C. difficile patients) as defined by the Glue Grant on admission and at days seven and 14.ResultsThe majority of CDI patients experienced complicated or intermediate clinical courses. The mean ages of all cohorts were less than 65 y and CDI patients were significantly older than uncomplicated patients without CDI. The CDI patients had increased days in the hospital and on the ventilator, as well as significantly higher new injury severity scores (NISS), and a greater percentage of patients with NISS >34 points compared with non-CDI patients. They also had greater Marshall and Denver multiple organ dysfunction scores than non-CDI uncomplicated patients, and greater creatinine, alkaline phosphatase, neutrophil count, lactic acid, and PiO2:FiO2 compared with all non-CDI cohorts on admission. In addition, the CDI patients had higher glucose concentrations and base deficit from uncomplicated patients and greater leukocytosis than complicated patients on admission. Several of these changes persisted to days seven and 14.ConclusionAnalysis of severe blunt trauma patients with C. difficile, as compared with non-CDI patients, reveals evidence of increased inflammation, immunosuppression, worse acute kidney injury, higher NISS, greater days in the hospital and on the ventilator, higher organ injury scores, and prolonged clinical courses. This supports reports of an increased prevalence of CDI in a younger population not believed previously to be at risk. This unique population may have specific genomic or inflammation-related risk factors that may play more important roles in disease susceptibility. Prospective analysis may allow early identification of at-risk patients, creation of novel therapeutics, and improved understanding of how and why C. difficile colonization transforms into infection after severe blunt trauma.

Project description:BackgroundRectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7-15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies.MethodsThe present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18-90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications.DiscussionThis double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure.Trial registrationClinicalTrials.gov NCT03720262. Registered on October 25, 2018.

Dataset Information

Loop ileostomy versus total colectomy as surgical treatment for Clostridium difficile-associated disease: An Eastern Association for the Surgery of Trauma multicenter trial.

Publications

Loop ileostomy versus total colectomy as surgical treatment for Clostridium difficile-associated disease: An Eastern Association for the Surgery of Trauma multicenter trial.

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