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The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial.

ABSTRACT: To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in the Trendelenburg position. This position results in hemodynamic changes that may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as an alternative to the Trendelenburg position during laparoscopic surgery. The objective of this trial is to study the impact of the use of an intraoperative retractor sponge on the duration of the hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer.The SPONGE trial is a monocenter study and follows the cohort multiple randomized controlled trial (cmRCT) design. It will be conducted within a multicenter prospective observational cohort of colorectal cancer patients of all stages, for whom longitudinal clinical data and patient-reported outcomes are collected. Patients within the cohort, who will undergo laparoscopic surgery for distal colon or rectal cancer, are eligible for inclusion and form a subcohort. From this subcohort, a 1:1 random sample will be offered to undergo surgery with the use of the retractor sponge. Patients from the subcohort who are not selected will undergo standard treatment, that is, surgery in the Trendelenburg position. The primary endpoint is the duration of the postoperative hospital stay. Secondary outcomes are duration of surgery; intraoperative blood loss and fluid balance; and postoperative body temperature, oxygenation and complications. Both arms require 94 patients.This study is the first randomized controlled trial to evaluate the effect of sponge-assisted laparoscopic colorectal surgery in comparison with standard Trendelenburg position on hospital stay and peri- and postoperative complications. Results of this study will also be relevant for other surgical procedures in the pelvic region. The present study is the second randomized controlled trial according to the cmRCT design, which is embedded within our colorectal cancer cohort.ClinicalTrials.gov NCT02574013 . Registered 27 September 2015.

SUBMITTER: Couwenberg AM

PROVIDER: S-EPMC4787008 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial.

Couwenberg Alice M AM Burbach Maarten J P MJ Smits Anke B AB Van Vulpen Marco M Van Grevenstein Wilhemina M U WM Noordzij Peter G PG Verkooijen Helena M HM

Trials 20160310 1

<h4>Background</h4>To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in the Trendelenburg position. This position results in hemodynamic changes that may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as an alternative to the Trendelenburg position during laparoscopic surgery. The objective of this trial ...[more]

PMID: 26964861

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Project description:BackgroundSince postoperative pulmonary complications are one of the main causes of morbidity and mortality in patients undergoing lung resection surgery, we performed a meta-analysis to compare the incidence of postoperative pulmonary complications and hospital death, and the length of hospital stay in patients who received nonintubated or intubated anesthesia during thoracoscopic surgery for lung resection and further explore the tricks in nonintubated anesthesia.MethodsPubMed, Embase, and Cochrane Library were searched from inception to September 2017. We included eligible research comparing nonintubated anesthesia with intubated anesthesia in thoracoscopic surgery for lung resection. The primary outcomes involved postoperative pulmonary complications, hospital death, and hospital stay. The rates and causes of conversion from nonintubated anesthesia to intubated anesthesia were also analyzed.ResultsAfter screening through 754 potentially relevant articles, we included 3 randomized controlled trials and 7 observational studies with 1138 patients. There was no perioperative mortality in 2 groups. The nonintubated group revealed comparable postoperative pulmonary complications (OR?=?0.57; P?=?.07; P for heterogeneity?=?.49, I?=?0%) and shorter hospital stay (WMD?=?-1.10; P?<?.00001; P for heterogeneity?=?.84, I?=?0%) in overall findings with little heterogeneity.ConclusionNonintubated anesthesia in thoracoscopic surgery for lung resection shortened the length of hospital stay compared with intubated anesthesia. However, the incidence of postoperative pulmonary complications was comparable between nonintubated and intubated group. Given the potential perioperative emergencies, such as persistent hypoxemia, carbon dioxide retention, or extensive pleural adhesions, nonintubated anesthesia in lung resection surgery requires extra vigilance to ensure the safety of the patients and the success of the surgery. Powerful randomized controlled trials in the future are essential to provide more certainty and address long-term effectiveness. Only when anesthesiologists and surgeons make efforts together can better clinical outcomes in lung resection surgery be achieved.

Project description:BackgroundRepresentative statistics of surgical care among patients with kidney cancer are scant. With the introduction of the diagnosis related group system in Germany, it is now possible to provide nationwide statistics on surgical care. We studied in-hospital mortality risk in relation to comorbidity and complications, length of hospital stay in relation to surgical approach and comorbidity, and risk of complications in relation to surgical approach among kidney cancer patients undergoing nephrectomy.MethodsWe analyzed the nationwide hospitalization file of the years 2005 and 2006 including 23,753 hospitalizations with a diagnosis of renal cancer and partial or complete nephrectomy and classified comorbidity (Charlson comorbidity index) and complications. Length of stay, risk of in-hospital complications and in-hospital death were analyzed by linear regression and log-linear regression (relative risks (RR) and 95% confidence intervals (95% CI)).ResultsThe overall in-hospital mortality was 1.4%. Per one unit increase of the Charlson comorbidity index, the adjusted risk of in-hospital mortality increased by 53% (95% CI 47-59%). The risks of bleeding or acute posthaemorrhagic anemia, respiratory, urological and gastrointestinal complications and infections ranged between 1.1% and 2.7% with the exception of bleeding or acute posthaemorrhagic anemia with 18.4%. Complications were associated with an increased adjusted in-hospital mortality risk. Highest adjusted mortality risk ratios were observed for gastrointestinal (RR = 3.61, 95% CI 2.32-5.63) and urological complications (RR = 3.62, 95% CI 2.62-5.00). The risk of haemorrhage or acute posthaemorrhagic anemia was lower for total laparoscopic nephrectomies than total open nephrectomies. The adjusted risk of gastrointestinal complications was lower for partial open compared to total open nephrectomy (adjusted RR = 0.66, 95% CI 0.45-0.97). Total laparoscopic nephrectomy was associated with shorter length of stay (-3.3 days; 95% CI 2.9-3.7 days) compared to total open nephrectomy. The estimated age-adjusted increase of length of stay per one unit increase of the Charlson comorbidity index was 1.3 days (95% CI 1.2-1.4 days).ConclusionsIn this representative population-based analysis, we found that the surgical approach is associated with the risk of complications and length of hospital stay. Furthermore, in the era of ageing populations, renal cancer patients with comorbidities should be counseled about their increased in-hospital mortality risk.

Project description:BackgroundThe role of the positive end-expiratory pressure (PEEP) and lung recruitment manoeuvre (LRM) combination (termed open-lung strategy, OLS) during intra-operative mechanical ventilation is not clear.ObjectiveTo determine whether an open-lung strategy constituting medium PEEP (6-8 cmH2O) and repeated LRMs protects against postoperative complications in at-risk patients undergoing laparoscopic colorectal cancer resection under low-tidal-volume ventilation.DesignA prospective, assessor-blinded, randomised controlled trial.SettingSingle university-affiliated hospital, conducted from January 2017 to October 2018.PatientsA total of 280 patients at risk of pulmonary complications, scheduled for laparoscopic colorectal cancer resection under general anaesthesia and low-tidal-volume (6-8 ml kg-1 predicted body weight) ventilation.InterventionThe patients were randomly assigned (1 : 1) to a PEEP of 6-8 cmH2O with LRMs repeated every 30 min (OLS group) or a zero PEEP without LRMs (non-OLS group).Main outcome measuresThe primary outcome was a composite of major pulmonary and extrapulmonary complications occurring within 7 days after surgery. The secondary outcomes included intra-operative potentially harmful hypotension and the need for vasopressors.ResultsA total of 130 patients from each group were included in the primary outcome analysis. Primary outcome events occurred in 24 patients (18.5%) in the OLS group and 43 patients (33.1%) in the non-OLS group [relative risk, 0.46; 95% confidence interval (CI), 0.26 to 0.82; P = 0.009). More patients in the OLS group developed potentially harmful hypotension (OLS vs. non-OLS, 15% vs. 4.3%; P = 0.004) and needed vasopressors (25% vs. 8.6%; P < 0.001).ConclusionAmong at-risk patients undergoing laparoscopic colorectal cancer resection under low-tidal-volume ventilation, an open-lung strategy with a PEEP of 6-8 cmH2O and repeated LRMs reduced postoperative complications compared with a strategy using zero PEEP without LRMs. Of note, LRMs should be used with caution in patients with haemodynamic instability.Trial registrationClinicaltrials.gov identifier: NCT03160144.

Project description:BackgroundPostoperative complications after major gastrointestinal surgery are a major contributor to hospital costs. Thus, reducing postoperative complications is a key target for cost-containment strategies. We aimed to evaluate the relationship between postoperative complications and hospital costs following small bowel resection.MethodsPostoperative complications were recorded for 284 adult patients undergoing major small bowel resection surgery between January 2013 and June 2018. Complications were defined and graded according to the Clavien-Dindo classification system. In-hospital cost of index admission was calculated using an activity-based costing methodology; it was reported in US dollars at 2019 rates. Regression modeling was used to investigate the relationships among a priori selected perioperative variables, complications, and costs.FindingsThe overall complication prevalence was 81.6% (95% CI: 85.7-77.5). Most complications (69%) were minor, but 22.9% of patients developed a severe complication (Clavien-Dindo grades III or IV). The unadjusted median total hospital cost for patients with any complication was 70% higher than patients without complications (median [IQR] USD 19,659.64 [13,545.81-35,407.14] vs. 11,551.88 [8,849.46-15,329.87], P < 0.001). The development of 1, 2, 3, and ≥ 4 complications increased hospital costs by 11%, 41%, 50%, and 195%, respectively. Similarly, more severe complications incurred higher hospital costs (P < 0.001). After adjustments were made (for the Charlson Comorbidity Index, anemia, surgical urgency and technique, intraoperative fluid administration, blood transfusion, and hospital readmissions), a greater number and increased severity of complications were associated with a higher adjusted median hospital cost. Patients who experienced complications had an adjusted additional median cost of USD 4,187.10 (95% CI: 1,264.89-7,109.31, P = 0.005) compared to those without complications.ConclusionsPostoperative complications are a key target for cost-containment strategies. Our findings demonstrate a high prevalence of postoperative complications following small bowel resection surgery and quantify their associated increase in hospital costs.Trial registrationAustralian Clinical Trials Registration number: 12620000322932.

Dataset Information

The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial.

Publications

The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial.

Similar Datasets

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