Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial.
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SUBMITTER: Elsner AT
PROVIDER: S-EPMC8492188 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy. METHODS:Early closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal resection for cancer. Inclusion of participants was made after index surgery. Exclusion criteria were signs of anastomotic leakage, diabetes mellitus, steroid treatment, and signs of postoperative complications at clinical evaluation 1-4 days after rectal resection. HRQOL was evaluated at 3, 6 and 12 months after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®). RESULTS:There were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12 months, to which only 54-55 per cent of the patients responded owing to an error in questionnaire distribution. There were no clinically significant differences in any questionnaire scores between the groups at 3, 6 or 12 months. CONCLUSION:Although the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on the patients' HRQOL. Registration number: NCT01287637 (https://www.clinicaltrials.gov).
| S-EPMC5814870 | biostudies-literature
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.
| S-EPMC6946724 | biostudies-literature
Project description:BackgroundLow anterior resection syndrome (LARS) has a significant impact on postoperative quality of life. Although early closure of an ileostomy is safe in selected patients, functional outcomes have not been investigated. The aim was to compare bowel function and the prevalence of LARS in patients who underwent early or late closure of an ileostomy after rectal resection for cancer.MethodsEarly closure (8-13 days) was compared with late closure (after 12 weeks) of the ileostomy following rectal cancer surgery in a multicentre RCT. Exclusion criteria were: signs of anastomotic leakage, diabetes mellitus, steroid treatment and postoperative complications. Bowel function was evaluated using the LARS score and the Memorial Sloan Kettering Cancer Center Bowel Function Instrument (BFI).ResultsFollowing index surgery, 112 participants were randomized (55 early closure, 57 late closure). Bowel function was evaluated at a median of 49 months after stoma closure. Eighty-two of 93 eligible participants responded (12 had died and 7 had a permanent stoma). Rates of bowel dysfunction were higher in the late closure group, but this did not reach statistical significance (major LARS in 29 of 40 participants in late group and 25 of 42 in early group, P = 0·250; median BFI score 63 versus 71 respectively, P = 0·207). Participants in the late closure group had worse scores on the urgency/soiling subscale of the BFI (14 versus 17; P = 0·017). One participant in the early group and six in the late group had a permanent stoma (P = 0·054).ConclusionPatients undergoing early stoma closure had fewer problems with soiling and fewer had a permanent stoma, although reduced LARS was not demonstrated in this cohort. Dedicated prospective studies are required to evaluate definitively the association between temporary ileostomy, LARS and timing of closure.
| S-EPMC6590150 | biostudies-literature
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.
| S-EPMC6196810 | biostudies-other
Project description:Background/aimEndometriosis infiltrating the rectum often requires resection with a protecting stoma. A ghost ileostomy (GI) is an alternative to prevent the psychological burden for the young women affected. The present study evaluated the safety and cost-effectiveness of the ghost ileostomy (GI) procedure in a group of patients after rectal resection for deep infiltrating endometriosis.Patients and methodsThe prospective controlled interventional trial was conducted in 54 consecutive patients with deep infiltrating endometriosis of the rectum. GI was considered after ultra-low resection with primary anastomosis, previous colorectal anastomosis, or pelvic redo surgery. Loop ileostomy (LI) was performed after simultaneous colpotomy with suture, only. Operating time, morbidity according to the Clavien-Dindo classification (CDC), duration of hospital stay, and patient satisfaction were obtained. Individual costs were estimated for the endometriosis procedure with or without a GI or LI, including stoma supply and closure expenses.ResultsOf the 54 patients, 27 received GI (50%), whereas 4 underwent LI (7%). The remaining 23 patients received no outlet (NO). The complication rate did not differ among the GI, LI, and NO groups. Two cases were re-operated and required a diverting stoma, one in the GI and the NO group each. The additional healthcare expenses for each patient receiving a LI averaged 6,000 €. The patients were very satisfied with the option of a GI.ConclusionGI is a cost-effective and safe alternative to LI after rectal resection for deep infiltrating endometriosis in cases where it is required. The individual costs per patient were reduced substantially, with a cumulative savings of 160,000 € in healthcare expenditure. Additionally, the method clearly lowers the psychological burden on the young women concerned.
| S-EPMC9087109 | biostudies-literature
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.
| S-EPMC3191573 | biostudies-literature
Project description:ObjectiveThe aim of this study was to compare ghost ileostomy (GI) and loop ileostomy (LI) in patients undergoing oncologic resection for rectal cancer in terms of postoperative morbidity.Summary background dataLIs are often fashioned to protect downstream anastomoses following oncologic resection for low rectal cancer at medium-to-high risk of anastomotic leak. More recently, GIs have been utilized in patients with low-to-medium risk anastomoses to reduce the rate of unnecessary stomas.MethodsMedline, Embase, and CENTRAL were systematically searched. Studies investigating the use of GI in patients undergoing oncologic resection for rectal cancer were included. The primary outcomes were anastomotic leak and postoperative morbidity. Secondary outcomes included stoma-related complications and length of stay (LOS). Pairwise meta-analyses were performed with inverse variance random effects.ResultsFrom 242 citations, 14 studies with 946 patients were included. In comparative studies, 359 patients were undergoing GI and 266 patients were undergoing LI. Pairwise meta-analysis revealed no differences in the prevalence of anastomotic leak (OR 1.40, 95%CI .73-2.68, P = .31), morbidity (OR .76, 95%CI .44-1.30, P = .32), or LOS (SMD -.05, 95%CI -.33-.23, P = .72). International Study Group of Rectal Cancer anastomotic leak grades were as follows: Grade A (GI 0% vs LI 13.3%), Grade B (GI 80.9% vs LI 86.7%), Grade C (GI 19.1% vs LI 0%).ConclusionsGI appears to be a safe alternative to LI following oncologic resection for rectal cancer. Larger, prospective comparative studies are warranted to evaluate the use of GI in patients deemed to be at low-to-medium risk of anastomotic leak.
| S-EPMC10403968 | biostudies-literature
Project description:IntroductionIn closure of a stoma, the small working space and adhesions hinder a precise surgical procedure, compared with conventional approaches to digestive surgery. The aim of this prospective study was to introduce a new technique of laparoscopic stoma closure (LASC).Materials and surgical techniquesAfter starting with three trocars, it is a priority to dissect around the arising ileum; a linear stapler is precisely inserted in both orifices of the loop stoma and applied two times, extracorporeally. Ultimately, both the oral and anal sides of the loop ileum are cut and closed using a linear cutter stapler in a delta-shaped manner just under the abdominal wall, intracorporeally. Eventually, the arising stoma is removed using an intra-abdominal and cutaneous approach.DiscussionLASC for patients with a temporary loop ileostomy is safe and feasible. More data and experience will be required to verify the benefits of this new technique.
| S-EPMC7687255 | biostudies-literature
Project description: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.
| S-EPMC7919002 | biostudies-literature
Project description:BackgroundMinimally invasive liver surgery (MILS) has a high variance in the type of resection and complexity, which has been underestimated in learning curve studies in the past. The aim of this work was to evaluate complexity-adjusted learning curves over time for laparoscopic liver resection (LLR) and robotic liver resection (RLR).MethodsCumulative sum analysis (CUSUM) and complexity adjustment were performed using the Iwate score for LLR and RLR (n = 647). Lowest point of smoothed data was used to capture the cutoff of the increase in complexity. Data were collected retrospectively at the Department of Surgery of the Charité-Universitätsmedizin Berlin.ResultsA total of 132 RLR and 514 LLR were performed. According to the complexity-adjusted CUSUM analysis, the initial learning phase was reached after 117 for LLR and 93 procedures for RLR, respectively. With increasing experience, the rate of (extended) right hemihepatectomy multiplied from 8.4% to 18.9% for LLR (P = 0.031) and from 21.6% to 58.3% for RLR (P < 0.001). Complication rates remained comparable between both episodes for LLR and RLR (T1 vs T2, P > 0.05). The complexity-adjusted CUSUM analysis demonstrated for blood transfusion, conversion, and operative time an increase during the learning phase (T1), while a steady state was reached in the following (T2).ConclusionsThe learning phase for MILS after adjusting for complexity is about 4 times longer than assumed in previous studies, which should urge caution.
| S-EPMC10431481 | biostudies-literature