Dataset Information

Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial.

ABSTRACT: The aim of this study was to assess quality of life and bowel function in patients undergoing early vs. standard ileostomy closure. We retrospectively assessed patients from our previous randomized controlled trial. Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other. Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared. Thirty-six months (17-97) after stoma closure, we contacted patients by phone and filled in two questionnaires-The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and low anterior resection syndrome (LARS) score. This index trial was not powered to assess the difference in bowel function between the two groups. All the patients in the SC group had anastomosis <6 cm from the anal verge compared to 42 of 43 (97.7%) in the EC group. There were no statistically significant differences between EC (26 patients) and SC (25 patients) groups in the EORTC QLQ-C30 and LARS questionnaires. Global quality of life was 37.2 (0-91.7; ±24.9) in the EC group vs. 34.3 (0-100; ±16.2) in the SC (p = 0.630). Low anterior resection syndrome was present in 46% of patients in the EC and 56% in the SC group (p = 0.858). Major LARS was found more often in younger patients. However, no statistical significance was found (p = 0.364). The same was found with quality of life (p = 0.219). Age, gender, ileostomy closure timing, neoadjuvant treatment, complications had no effect of worse bowel function or quality of life. There was no difference in quality of life or bowel function in the late postoperative period after the early vs. late closure of ileostomy based on two questionnaires and small sample size. None of our assessed risk factors had a negative effect on bowel function o quality of life.

SUBMITTER: Dulskas A

PROVIDER: S-EPMC7919002 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial.

Dulskas Audrius A Petrauskas Vidas V Kuliavas Justas J Bickaite Klaudija K Kairys Mikalojus M Pauza Kastytis K Kilius Alfredas A Sangaila Egidijus E Bausys Rimantas R Stratilatovas Eugenijus E

Journal of clinical medicine 20210215 4

The aim of this study was to assess quality of life and bowel function in patients undergoing early vs. standard ileostomy closure. We retrospectively assessed patients from our previous randomized controlled trial. Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other. Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared. Thirty-six months (17-97) after stoma closur ...[more]

PMID: 33671925

Similar Datasets

Project description:BACKGROUND:Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial. METHODS:Early closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector. RESULTS:Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations. CONCLUSIONS:The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage. CLINICAL TRIAL:Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.

Project description:ObjectiveThe objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal).BackgroundReversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7-9% and minor complications varying from 4-5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality.Design and methodsEarly closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0-12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation).DiscussionThe aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637.

Project description:BackgroundThe purpose of this study was to characterize associations among serum proteins, negative-pressure wound therapy (NPWT) fluid loss, and primary fascial closure (PFC) following emergent laparotomy and temporary abdominal closure (TAC). We hypothesized that high levels of C-reactive protein (CRP) and NPWT output would be associated with hypoalbuminemia and failure to achieve PFC.MethodsWe performed a retrospective analysis of 233 patients managed with NPWT TAC. Serum proteins and resuscitation indices were assessed on admission, initial laparotomy, and then at 48 hours, 96 hours, 7 days, and discharge. Correlations were assessed by Pearson coefficient. Multivariable regression was performed to identify predictors of PFC with cutoff values for continuous variables determined by Youden index.ResultsPatients who failed to achieve PFC (n = 55) had significantly higher CRP at admission (249 vs. 148 mg/L, p = 0.003), initial laparotomy (237 vs. 154, p = 0.002), and discharge (124 vs. 72, p = 0.003), as well as significantly lower serum albumin at 7 days (2.3 vs. 2.5 g/dL, p = 0.028) and discharge (2.5 vs. 2.8, p = 0.004). Prealbumin (in milligrams per deciliter) was similar between groups at each time point. There was an inverse correlation between nadir serum albumin and total milliliters of NPWT output (r = -0.33, p < 0.001). Exogenous albumin administration (in grams per day) correlated with higher serum albumin levels at each time point: 48 hours: r = 0.26 (p = 0.002), 96 hours: r = 0.29 (p = 0.002), 7 days: r = 0.40 (p < 0.001). Albumin of less than 2.6 g/dL was an independent predictor of failure to achieve PFC (odds ratio, 2.59; 95% confidence interval, 1.02-6.61) in a multivariate model including abdominal sepsis, body mass index of greater than 40 kg/m, and CRP of greater than 250 mg/L.ConclusionsEarly and persistent systemic inflammation and high NPWT output were associated with hypoalbuminemia, which was an independent predictor of failure to achieve PFC. The utility of exogenous albumin following TAC requires further study.Level of evidencePrognostic study, level III; Therapeutic study, level IV.

Project description:INTRODUCTION:A defunctioning ileostomy is often formed during rectal cancer surgery to reduce the potentially fatal sequelae of anastomotic leak. Once the ileostomy is closed and bowel continuity restored, many patients can suffer poor bowel function, that is, low anterior resection syndrome (LARS). It has been suggested that delay to closure can increase incidence of LARS which is known to significantly reduce quality of life. Despite this, within the UK, time to closure of ileostomy is not subject to national targets within the National Health Service and delay to closure exceeds 18 months in one-third of patients. Clinical factors, surgeon and patient preference or service pressures may all impact time to closure, yet to date no study has investigated this. The aim of this UK-wide study is to assess time to ileostomy closure and identify reasons for delays. METHODS AND ANALYSIS:A UK-wide multicentre prospective snapshot study, together with retrospective analysis of ileostomy closure through The Dukes' Club Research Collaborative including patients undergoing ileostomy closure in a 3-month period (April to June 2018) and all patients who underwent anterior resection and ileostomy formation over a historical 12-month period (2015). Time to closure and incidence of 'non-closure' will be calculated. Units will be surveyed to determine local clinical and management protocols and barriers to timely closure. Multivariate linear regression analysis will be used to determine factors significantly associated with delay to ileostomy closure. ETHICS AND DISSEMINATION:Study approved by the South West-Exeter Research Ethics Committee and the Health Research Authority. Study results will be submitted for presentation at international conferences and for publication in peer-reviewed journals. Results will be presented to and discussed with the patient and public representatives and relevant national bodies to facilitate the development of consensus guidelines on optimum treatment pathways.

Dataset Information

Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial.

Publications

Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets