Safety of early ileostomy closure: a systematic review and meta-analysis of randomized controlled trials

Clausen, Frederik Bjerg; Dohrn, Niclas; Hølmich, Emma Rosenkrantz; Klein, Mads; Gögenür, Ismail

doi:10.1007/s00384-020-03761-1

Cited by 21 publications

(23 citation statements)

References 19 publications

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“…The meta-analysis showed no significant difference in the postoperative morbidity rate, anastomotic leak rate, rates of small bowel obstruction, bleeding, and ileus between EC and LC. Also, the meta-analysis of six RCTs performed by Clausen et al [ 202 ] could not discern a statistically significant difference in postoperative complications when comparing EC (within 2 weeks) and LC of DI. Overall postoperative morbidity in the EC group was 20.2% compared with 18.9% in the LC (RR = 1.13, P = 0.66), major complications (Clavien-Dindo grade ≥ 3) in the EC group was 5.2% compared with 3.6% in the LC group (RR = 1.12, P = 0.86), anastomotic leakage in the EC group was 3.3% compared with 3.5% in the LC group (RR = 0.89, P = 0.83).…”

Section: Resultsmentioning

confidence: 97%

“…The DI itself is associated with relevant morbidity, including skin irritation, parastomal hernias, stomal prolapse or retraction, and decreased quality of life (QoL) for the patient. DI-related morbidity rates reported in randomized controlled trials (RCTs) range from 2.9% to 62.2%, with a median rate of 14.3% [ 202 ]. As morbidity rates increase with time to ileostomy closure [ 203 ], it has been suggested that early closure (EC) of the DI could reduce adverse outcomes while still preserving the protective effect of the DI [ 204 ].…”

Section: Resultsmentioning

confidence: 99%

“…To improve QoL, early stoma closure within 2 weeks from the index operation has been proposed. Six randomized controlled trials [ 204 , 210 – 214 ] published over the past 10 years, and four systematic reviews with meta-analysis published over the past 2 years [ 202 , 215 – 217 ] were evaluated by the meta-analysis team.…”

Section: Resultsmentioning

confidence: 99%

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Multidisciplinary management of elderly patients with rectal cancer: recommendations from the SICG (Italian Society of Geriatric Surgery), SIFIPAC (Italian Society of Surgical Pathophysiology), SICE (Italian Society of Endoscopic Surgery and new technologies), and the WSES (World Society of Emergency Surgery) International Consensus Project

et al. 2021

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Background and aims Although rectal cancer is predominantly a disease of older patients, current guidelines do not incorporate optimal treatment recommendations for the elderly and address only partially the associated specific challenges encountered in this population. This results in a wide variation and disparity in delivering a standard of care to this subset of patients. As the burden of rectal cancer in the elderly population continues to increase, it is crucial to assess whether current recommendations on treatment strategies for the general population can be adopted for the older adults, with the same beneficial oncological and functional outcomes. This multidisciplinary experts’ consensus aims to refine current rectal cancer-specific guidelines for the elderly population in order to help to maximize rectal cancer therapeutic strategies while minimizing adverse impacts on functional outcomes and quality of life for these patients. Methods The discussion among the steering group of clinical experts and methodologists from the societies’ expert panel involved clinicians practicing in general surgery, colorectal surgery, surgical oncology, geriatric oncology, geriatrics, gastroenterologists, radiologists, oncologists, radiation oncologists, and endoscopists. Research topics and questions were formulated, revised, and unanimously approved by all experts in two subsequent modified Delphi rounds in December 2020–January 2021. The steering committee was divided into nine teams following the main research field of members. Each conducted their literature search and drafted statements and recommendations on their research question. Literature search has been updated up to 2020 and statements and recommendations have been developed according to the GRADE methodology. A modified Delphi methodology was implemented to reach agreement among the experts on all statements and recommendations. Conclusions The 2021 SICG-SIFIPAC-SICE-WSES consensus for the multidisciplinary management of elderly patients with rectal cancer aims to provide updated evidence-based statements and recommendations on each of the following topics: epidemiology, pre-intervention strategies, diagnosis and staging, neoadjuvant chemoradiation, surgery, watch and wait strategy, adjuvant chemotherapy, synchronous liver metastases, and emergency presentation of rectal cancer.

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Section: Resultsmentioning

confidence: 97%

Section: Resultsmentioning

confidence: 99%

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Multidisciplinary management of elderly patients with rectal cancer: recommendations from the SICG (Italian Society of Geriatric Surgery), SIFIPAC (Italian Society of Surgical Pathophysiology), SICE (Italian Society of Endoscopic Surgery and new technologies), and the WSES (World Society of Emergency Surgery) International Consensus Project

et al. 2021

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“…We developed two scenarios according to two different risk ratio reduction (RRR) values. Scenario 1 was based on RRR values pragmatically chosen to represent a conservative intervention effect: 10% for post-operative morbidity outcome, 1% leak of rectal anastomosis, 5% unplanned reoperations [21][22][23][24][25]44]. Scenario 2 represented a sensitivity analysis where an RRR of 25% was chosen to represent an optimistic intervention effect for all outcomes.…”

Section: Trial Sequential Analysismentioning

confidence: 99%

“…Some recent meta-analyses have suggested that early ileostomy closure is effective and safe in selected patients [21][22][23][24]. However, others reported that early closure increased the rate of post-operative complications [25].…”

Section: Introductionmentioning

confidence: 99%

Early versus delayed defunctioning ileostomy closure after low anterior resection for rectal cancer: a meta-analysis and trial sequential analysis of safety and functional outcomes

Podda

Coccolini²,

Gerardi

et al. 2022

Int J Colorectal Dis

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Purpose We performed a systematic review and meta-analysis with trial sequential analysis (TSA) to answer whether early closure of defunctioning ileostomy may be suitable after low anterior resection. Methods MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched, up to October 2021, for RCTs comparing early closure (EC ≤ 30 days) and delayed closure (DC ≥ 60 days) of defunctioning ileostomy. The risk ratio (RR) with 95% CI was calculated for dichotomous variables and the mean difference (MD) with 95% CI for continuous variables. The GRADE methodology was implemented for assessing Quality of Evidence (QoE). TSA was implemented to address the risk of random error associated with sparse data and/or multiple testing. Results Seven RCTs were included for quantitative synthesis. 599 patients were allocated to either EC (n = 306) or DC (n = 293). EC was associated with a higher rate of wound complications compared to DC (RR 2.56; 95% CI 1.33 to 4.93; P = 0.005; I2 = 0%, QoE High), a lower incidence of postoperative small bowel obstruction (RR 0.46; 95% CI 0.24 to 0.89; P = 0.02; I2 = 0%, QoE moderate), and a lower rate of stoma-related complications (RR 0.26; 95% CI 0.16 to 0.42; P < 0.00001; I2 = 0%, QoE moderate). The rate of minor low anterior resection syndrome (LARS) (RR 1.13; 95% CI 0.55 to 2.33; P = 0.74; I2 = 0%, QoE low) and major LARS (RR 0.80; 95% CI 0.59 to 1.09; P = 0.16; I2 = 0%, QoE low) did not differ between the two groups. TSA demonstrated inconclusive evidence with insufficient sample sizes to detect the observed effects. Conclusion EC may confer some advantages compared with a DC. However, TSA advocated a cautious interpretation of the results. Prospero Register ID CRD42021276557

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Frühzeitige Ileostoma-Rückverlagerung nach Rektumresektion

Holmer

2022

coloproctology

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Safety of early ileostomy closure: a systematic review and meta-analysis of randomized controlled trials

Cited by 21 publications

References 19 publications

Early versus delayed defunctioning ileostomy closure after low anterior resection for rectal cancer: a meta-analysis and trial sequential analysis of safety and functional outcomes

Frühzeitige Ileostoma-Rückverlagerung nach Rektumresektion

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