The Effectiveness of Micropower Vacuum Dressings in Reducing Superficial Incisional Surgical Site Infection in Loop Ileostomy Closure: Prospective, Randomized Controlled Trial
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 80990 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:BackgroundIncisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre randomised-controlled trial (RCT) with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone.MethodsP.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ≥ 1000 μm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1,014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. The primary endpoint will be the frequency of incision hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas, and enterocutaneous fistulas), postoperative pain, the number of revision surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien classification.DiscussionDepending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal.Trial registrationDRKS00027921, U1111-1273-4657.
| S-EPMC9890770 | biostudies-literature
Project description:Introduction:A Loop ileostomy is one of the most common techniques used in colorectal surgery to establish a reversible faecal diversion and bypass the large bowels, in order to protect either a downstream colorectal anastomosis or a coloanal anastomosis. However, it is a procedure that can cause a plethora of complications including long term ones such as the psychological effects. Currently, there is no consensus regarding the optimal time to perform closure of a loop ileostomy. Some studies suggested the early reversal of ileostomy procedure as a solution to reduce these complications. This study aims to review the available literature in order to ascertain the benefits behind early closure of loop ileostomy. Methods:The literature was searched for all studies that included a comparison between the outcomes of early and late closure of loop ileostomy in terms of morbidity, mortality, or quality of life, where available. Early closure of loop ileostomy is defined as closure less than three months and late as more than three months, in accordance with conventional literature. The resultant articles were filtered using our inclusion and exclusion criteria. Finally, the remaining articles were assessed for quality and their results were compared to one another in order to draw our conclusions. Results and Discussion. The results were slightly inclined toward early closure of loop ileostomy. However, there were limitations of the studies reviewed, including the heterogenicity of studies, selection bias, lack of clear definition of measured outcomes, and small sample size. Taking that into consideration, the results of early closure of loop ileostomies in the selected patients were promising and require further investigation.
| S-EPMC7481925 | 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:OBJECTIVE:To compare superficial surgical site infection (SSI) rates between delayed primary wound closure (DPC) and primary wound closure (PC) for complicated appendicitis. BACKGROUND:SSI is common in appendectomy for complicated appendicitis. DPC is preferentially used over PC, but its efficacy is still controversial. METHODS:A multicenter randomized controlled trial was conducted in 6 hospitals in Thailand, enrolling patients with gangrenous and ruptured appendicitis. Patients were randomized to PC (ie, immediately wound closure) or DPC (ie, wound closure at postoperative days 3-5). Superficial SSI was defined by the Center for Disease Control criteria. Secondary outcomes included postoperative pain, length of stay, recovery time, quality of life, and cost of treatment. RESULTS:In all, 303 and 304 patients were randomized to PC and DPC groups, and 5 and 4 patients were lost to follow-up, respectively, leaving 300 and 298 patients in the modified intention-to-treat analysis. The superficial SSI rate was lower in the PC than DPC groups [ie, 7.3% (95% confidence interval 4.4, 10.3) vs 10% (95% CI 6.6, 13.3)] with a risk difference (RD) of -2.7% (-7.1%, 1.9%), but this RD was not significant. Postoperative pain, length of stay, recovery times, and quality of life were nonsignificantly different with corresponding RDs of 0.3 (-2.5, 3.0), -0.1 (-0.5, 0.3), -0.2 (-0.8, 0.4), and 0.02 (-0.01, 0.04), respectively. However, costs for PC were 2083 (1410, 2756) Baht cheaper than DPC (?$60 USD). CONCLUSIONS:Superficial SSI rates for the PC group were slightly lower than DPC group, but this did not reach statistical significance. Costs were significantly lower for the PC group.
| S-EPMC5865487 | biostudies-literature
Project description:PurposeStoma site incisional hernia (SSIH) is a common complication, but its incidence and risk factors are not well known. The objective of this study is to explore the incidence and risk factors of SSIH and build a predictive model.MethodsWe performed a multicenter retrospective analysis on the patients who underwent enterostomy closure from January 2018 to August 2020. Patient's general condition, perioperative, intraoperative, and follow-up information was collected. The patients were divided into control group (no occurrence) and observation group (occurrence) according to whether SSIH occurred. Univariate and multivariate analysis were used to evaluate the risk factors of SSIH, following which we constructed a nomogram for SSIH prediction.ResultsOne hundred fifty-six patients were enrolled in the study. The incidence of SSIH was 24.4% (38 cases), of which 14 were treated with hernia mesh repair, and the others were treated with conservative treatment. Univariate and multivariate analysis showed that age ≥ 68 years (OR 1.045, 95% CI 1.002 ~ 1.089, P = 0.038), colostomy (OR 2.913, 95% CI 1.035 ~ 8.202, P = 0.043), BMI ≥ 25 kg/m2 (OR 1.181, 95% CI 1.010 ~ 1.382, P = 0.037), malignant tumor (OR 4.838, 95% CI 1.508 ~ 15.517, P = 0.008) and emergency surgery (OR 5.327, 95% CI 1.996 ~ 14.434, P = 0.001) are the independent risk factors for SSIH.ConclusionsBased on the results, a predictive model for the occurrence of SSIH was constructed to screen high-risk groups of SSIH. For patients at high risk for SSIH, how to deal with the follow-up and prevent the occurrence of SSIH is worth further exploration.
| S-EPMC10257324 | 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: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:Surgical site infections represent a considerable burden for healthcare systems. To obtain a consensus on the impact and future clinical and economic needs regarding SSI management in an era of multidrug resistance. A modified Delphi method was used to obtain consensus among experts from five European countries. The Delphi questionnaire was assembled by a steering committee, verified by a panel of experts and administered to 90 experts in 8 different surgical specialities (Abdominal, Cancer, Cardiac, General surgery, Orthopaedic, Thoracic, Transplant and Vascular and three other specialities (infectious disease, internal medicine microbiology). Respondents (n = 52) reached consensus on 62/73 items including that resistant pathogens are an increasing matter of concern and increase both treatment complexity and the length of hospital stay. There was strong positive consensus on the cost-effectiveness of early discharge (ED) programs, improvement of quality of life with ED and association between increased length of stay and economic burden to the hospital. However, established ED protocols were not widely available in their hospitals. Respondents expressed a positive consensus on the usefulness of antibiotics that allow ED. Surgeons are aware of their responsibility in an interdisciplinary team for the treatment of SSI, and of the impact of multidrug-resistant bacteria in the context of SSI. Reducing the length of hospital stays by applying ED protocols and implementing new treatment alternatives is crucial to reduce harm to patients and costs for the hospital.
| S-EPMC8397635 | biostudies-literature
Project description:PurposeTo evaluate safety and efficacy of a mesh reinforcement following stoma reversal to prevent stoma site incisional hernia (SSIH) and differences across the prostheses used.MethodsA systematic search of PubMed/MEDLINE, EMBASE, SCOPUS and Cochrane databases was conducted to identify comparative studies until September 2020. A meta-analysis of postoperative outcomes and a network meta-analysis for a multiple comparison of the prostheses with each other were performed.ResultsSeven studies were included in the analysis (78.4% ileostomy and 21.6% colostomy) with a total of 1716 patients with (n = 684) or without (n = 1032) mesh. Mesh placement was associated with lower risk of SSIH (7.8%vs18.1%, OR0.266,95% CI 0.123-0.577, p < 0.001) than no mesh procedures but also with a longer operative time (SMD 0.941, 95% CI 0.462-1.421, p < 0.001). There was no statistically significant difference in terms of Surgical Site infection (11.5% vs 11.1%, OR 1.074, 95% CI 0.78-1.48, p = 0.66), seroma formation (4.4% vs 7.1%, OR 1.052, 95% CI 0.64-1.73, p = 0.84), anastomotic leakage (3.7% vs 2.7%, OR 1.598, 95% CI 0.846-3.019, p = 0.149) and length of stay (SMD - 0.579,95% CI - 1.261 to 0.102, p = 0.096) between mesh and no mesh groups. Use of prosthesis was associated with a significant lower need for a reoperation than no mesh group (8.1% vs 12.1%, OR 0.332, 95% CI 0.119-0.930, p = 0.036). Incidence of seroma is lower with biologic than polypropylene meshes but they showed a trend towards poor results compared with polypropylene or biosynthetic meshes.ConclusionDespite longer operative time, mesh prophylactic reinforcement at the site of stoma seems a safe and effective procedure with lower incidence of SSIH, need for reoperation and comparable short-term outcomes than standard closure technique. A significant superiority of a specific mesh type was not identified.
| S-EPMC8197707 | biostudies-literature
Project description:We investigated the initial coupling of agonist binding to channel gating of the nicotinic acetylcholine receptor using targeted molecular-dynamics (TMD) simulation. After TMD simulation to accelerate closure of the C-loops at the agonist binding sites, the region of the pore that passes through the cell membrane expands. To determine whether the structural changes in the pore result in ion conduction, we used a coarse-grained ion conduction simulator, Biology Boltzmann transport Monte Carlo, and applied it to two structural frames taken before and after TMD simulation. The structural model before TMD simulation represents the channel in the proposed "resting" state, whereas the model after TMD simulation represents the channel in the proposed "active" state. Under external voltage biases, the channel in the "active" state was permeable to cations. Our simulated ion conductance approaches that obtained experimentally and recapitulates several functional properties characteristic of the nicotinic acetylcholine receptor. Thus, closure of the C-loop triggers a structural change in the channel sufficient to account for the open channel current. This approach of applying Biology Boltzmann transport Monte Carlo simulation can be used to further investigate the binding to gating transduction mechanism and the structural bases for ion selection and translocation.
| S-EPMC2711404 | biostudies-literature