Fast-Track in Minimally Invasive Gynecology: A Randomized Trial Comparing Costs and Clinical Outcomes.
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ABSTRACT:
SUBMITTER: Lambat Emery S
PROVIDER: S-EPMC8632235 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Objective To compare the techniques for the osteosynthesis of intertrochanteric fractures with dynamic hip screws (DHSs) through the Hardinge and minimally-invasive access routes of the hip, evaluating the operative time, the degree of pain in the immediate postoperative period, the hematimetric loss, and the functional aspects of active mobility. Methods A randomized, double-blinded clinical trial in which 66 patients with intertrochanteric fractures were submitted to osteosynthesis by DHS. The patients were divided into a test group, submitted to the minimally-invasive access, and a control group, in whom the surgery was performed through the Hardinge route. Results Patients submitted to the minimally-invasive treatment presented a lower degree of postoperative pain compared to the group treated by the Hardinge lateral route ( p < 0.001), as well as lower hematimetric loss ( p < 0.001), shorter operative time ( p < 0.001), and improvement in immediate postoperative active mobility tests ( p <0.05). Conclusion The study demonstrated the clinical superiority of the minimally-invasive access route parameters analyzed in relation to the Hardinge access for the fixation of intertrochanteric fractures when DHS is the choice osteosynthesis method. Level of evidence I.
| S-EPMC8856856 | biostudies-literature
Project description:ObjectiveThe authors sought to determine whether the Fast Track mental health intervention delivered to individuals in childhood decreased mental health problems and the need for health services among the children of these individuals.MethodsThe authors examined whether Fast Track assignment in one generation of children (generation 2; G2) from grades 1 through 10 reduced parent-reported mental health problems and health services use in these children's children (generation 3; G3) 18 years later relative to a control group. The Fast Track intervention blended parent behavior-management training, child social-cognitive skills tutoring, home visits, and classroom social-ecology changes across grades 1-10 to ameliorate emerging conduct problems among the G2 children. For this study, 1,057 G3 children of Fast Track participants (N=581 intervention group, N=476 control group) were evaluated.ResultsG3 children of G2 parents who were randomized to the Fast Track intervention group used fewer general inpatient services and fewer inpatient or outpatient mental health services compared with G3 children of G2 parents randomized to the control group. Some of these effects were mediated: randomization to Fast Track predicted fewer internalizing problems and less use of corporal punishment among G2 adults at age 25, which subsequently predicted less general inpatient service use and outpatient mental health service use among the G3 children by the time the G2 parents were 34 years old. There were no significant differences between G3 children from these two groups on the use of other health services or on mental health measures.ConclusionsFast Track was associated with lower use of general inpatient services and inpatient and outpatient mental health services intergenerationally, but effects on parent-reported mental health of the children were not apparent across generations. Investing in interventions for the mental health of children could reduce service use burdens across generations.
| S-EPMC11137839 | biostudies-literature
Project description:BackgroundThe Institute of Medicine has included the comparison of minimally invasive surgical techniques in its research agenda. This study seeks to evaluate a model for the comparison of minimally invasive procedures using patient-reported outcomes.Study designA double-blinded randomized controlled trial (NCT01489436) was conducted. Baseline data were obtained, standardized anesthesia was induced, and patients were randomized to single-port (SP) or 4-port (FP) laparoscopic cholecystectomy. Perioperative care was standardized. The outcomes were pain (Visual Analog Scale) on postoperative day 1 (primary) and quality of life (Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment), serum cytokines, and heart rate variability (secondary). Analysis was intention to treat. Using identical occlusive dressings, patients and the outcomes assessor remained blinded until postoperative day 2.ResultsFifty-five patients were randomized to each arm. There was no difference in demographics. Visual Analog Scale pain score on postoperative day 1 was significantly different from baseline in each group (SP: 1.6 ± 1.9 to 4.2 ± 2.4 vs FP: 1.8 ± 2.3 to 4.2 ± 2.2), but not different from each other (p = 0.83). Patients in the FP arm reported significantly less fatigue on postoperative day 7 than patients in the SP group (3.1 ± 2.1 vs 4.2 ± 2.2; p = 0.009). Fewer patients in the FP group required postoperative oral narcotics before discharge (40% vs 60%; p = 0.056). Cytokines levels and heart rate variability were similar between arms. In patients followed for >1 year, no difference in umbilical hernia rates was noted.ConclusionsEarly postoperative quality of life data captured differences in fatigue, indicating improved recovery after FP within a controlled trial. Physiologic measures were similar, suggesting that the differences between SP and FP are minimal.
| S-EPMC4477204 | biostudies-literature
Project description:BackgroundFor patients with esophageal adenocarcinoma or cancer of the gastroesophageal junction, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison exists between MIE and RAMIE in the Western World for patients with esophageal adenocarcinoma.MethodsThis is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group superiority trial. All adult patients (age ≥ 18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 218) with resectable esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction are randomized to either RAMIE (n = 109) or MIE (n = 109). The primary outcome of this study is the total number of resected abdominal and mediastinal lymph nodes specified per lymph node station.ConclusionThis is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. The hypothesis of the proposed study is that RAMIE will result in a higher abdominal and mediastinal lymph node yield specified per station compared to conventional MIE. Short-term results and the primary endpoint (total number of resected abdominal and mediastinal lymph nodes per lymph node station) will be analyzed and published after discharge of the last randomized patient within this trial.Trial registrationClinicalTrials.gov Identifier: NCT04306458 . Registered 13th March 2020, https://clinicaltrials.gov/ct2/show/NCT04306458; Date of first enrolment 18.01.2021; Target sample size 218; Recruitment status: Recruiting; Protocol version 2; Issue date 10.03.2020; Rev. 02.02.2021; Authors ET, PCvdS, PPG.
| S-EPMC8474742 | biostudies-literature
Project description:Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting.LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs.The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.Dutch Trial Register, NTR5188 . Registered on 9 April 2015.
| S-EPMC5385082 | biostudies-other
Project description:Considerable technological advancements have recently been made with endovascular stent grafts for the treatment of abdominal aortic aneurysm (AAA). However, there is opportunity to further improve the efficiency of endovascular aneurysm repair (EVAR), which may yield better patient outcomes and lower perioperative treatment costs.The Least Invasive Fast-Track EVAR (LIFE) registry was developed to determine the clinical utility and cost effectiveness of the Ovation® Prime stent graft when used under least invasive conditions using a defined fast-track protocol. The LIFE study is a prospective multicenter post-market registry of the ultra-low profile (14F) Ovation Prime stent graft when used in the treatment of patients with AAA using a fast-track protocol, consisting of appropriate patient selection, bilateral percutaneous access, avoidance of general anesthesia and intensive care unit admission, and next-day discharge. The primary endpoint of the study is the proportion of subjects that experience a major adverse event within 30 days of the initial procedure. Primary endpoint data will be compared to a target performance goal. A total of 250 subjects will be enrolled at up to 40 sites in the United States. The first subject in this study was enrolled in October 2014 and enrollment is anticipated to continue through mid-2016.The recent development of ultra low-profile stent grafts enables EVAR using least invasive methods. A structured fast-track EVAR protocol may yield clinical and cost benefits versus standard EVAR.ClinicalTrials.gov Identifier: NCT02224794.
| S-EPMC4684921 | biostudies-literature
Project description:ObjectivesMinimally invasive extracorporeal circulation (MiECC) is suggested to have favourable impact on blood loss compared to conventional extracorporeal circulation. We aimed to compare the impact of both systems on coagulation.MethodsRandomized trial comparing endogenous thrombin-generating potential early after elective coronary surgery employing either MiECC group (n = 30) or conventional extracorporeal circulation group (n = 30). Secondary outcomes were in vivo thrombin generation, bleeding end points and haemodilution, as well as morbidity and mortality up to 30-day follow-up.ResultsCompared to the conventional extracorporeal circulation group, the MiECC group showed (i) a trend towards a higher early postoperative endogenous thrombin-generating potential (P = 0.06), (ii) lower intraoperative levels of thrombin-antithrombin complex and prothrombin fragment 1 + 2 (P < 0.001), (iii) less haemodilution early postoperatively as measured by haematocrit and weight gain, but without correlation to coagulation factors or bleeding end points. Moreover, half as many patients required postoperative blood transfusion in the MiECC group (17% vs 37%, P = 0.14), although postoperative blood loss did not differ between groups (P = 0.84). Thrombin-antithrombin complex levels (rs = 0.36, P = 0.005) and prothrombin fragment 1 + 2 (rs = 0.45, P < 0.001), but not early postoperative endogenous thrombin-generating potential (rs = 0.05, P = 0.72), showed significant correlation to increased transfusion requirements. The MiECC group demonstrated significantly lower levels of creatine kinase-MB, lactate dehydrogenase and free haemoglobin indicating superior myocardial protection, less tissue damage and less haemolysis, respectively. Perioperative morbidity and 30-day mortality did not differ between groups.ConclusionsConventional but not MiECC is associated with significant intraoperative thrombin generation despite full heparinization. No correlation between coagulation factors or bleeding end points with the degree of haemodilution could be ascertained.Clinicaltrials.gov identifierNCT03216720.
| S-EPMC7239600 | biostudies-literature
Project description:Introduction and hypothesisThe objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function.MethodsIn this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon's perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher's exact test, the Wilcoxon test and the Chi-squared test.ResultsOf 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as "more difficult than average" (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation.ConclusionsAlthough there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon's perception of case complexity.
| S-EPMC7247935 | biostudies-literature
Project description:BackgroundPerioperative health care utilization and costs in patients undergoing elective fast-track vs standard endovascular aneurysm repair (EVAR) remain unclear.MethodsThe fast-track EVAR group included patients treated with a 14 Fr stent graft, bilateral percutaneous access, no general anesthesia or intensive care monitoring, and next-day hospital discharge. The standard EVAR group was identified from Medicare administrative claims using a matching algorithm to adjust for imbalances in patient characteristics. Hospital outcomes included operating room time, intensive care monitoring, hospital stay, secondary interventions, and major adverse events (MAEs). Perioperative outcomes occurring from hospital discharge to 30 days postdischarge included MAE, secondary interventions, and unrelated readmissions.ResultsAmong 1000 matched patients (250 fast-track; 750 standard), hospital outcomes favored the fast-track EVAR group, including shorter operating room time (2.30 vs 2.83 hrs, P<0.001), shorter hospital stay (1.16 vs 1.69 d, P<0.001), less need for intensive care monitoring (4.4% vs 48.0%, P<0.001), and lower secondary intervention rate (0% vs 2.4%, P=0.01). Postdischarge outcomes also favored fast-track EVAR with a lower rate of MAE (0% vs 7.2%, P<0.001) and all-cause readmission (1.6% vs 6.8%, P=0.001). The total cost to the health care system during the perioperative period was $26,730 with fast-track EVAR vs $30,730 with standard EVAR. Total perioperative health care costs were $4000 (95% CI: $3130-$4830) lower with fast-track EVAR vs standard EVAR, with $2980 in savings to hospitals and $1030 savings to health care payers.ConclusionA fast-track EVAR protocol using a 14 Fr stent graft resulted in shorter procedure time, lower intensive care utilization, faster discharge, lower incidence of MAE, lower readmission rates, and lower perioperative costs compared to standard EVAR.
| S-EPMC6731968 | biostudies-literature
Project description:ImportanceAvailable data comparing the long-term results of hybrid minimally invasive esophagectomy (HMIE) with that of open esophagectomy are conflicting, with similar or even better results reported for the minimally invasive esophagectomy group.ObjectiveTo evaluate the long-term, 5-year outcomes of HMIE vs open esophagectomy, including overall survival (OS), disease-free survival (DFS), and pattern of disease recurrence, and the potential risk factors associated with these outcomes.Design, setting, and participantsThis randomized clinical trial is a post hoc follow-up study that analyzes the results of the open-label Multicentre Randomized Controlled Phase III Trial, which enrolled patients from 13 different centers in France and was conducted from October 26, 2009, to April 4, 2012. Eligible patients were 18 to 75 years of age and were diagnosed with resectable cancer of the middle or lower third of the esophagus. After exclusions, patients were randomized to either the HMIE group or the open esophagectomy group. Data analysis was performed on an intention-to-treat basis from November 19, 2019, to December 4, 2020.InterventionsHybrid minimally invasive esophagectomy (laparoscopic gastric mobilization with open right thoracotomy) was compared with open esophagectomy.Main outcomes and measuresThe primary end points of this follow-up study were 5-year OS and DFS. The secondary end points were the site of disease recurrence and potential risk factors associated with DFS and OS.ResultsA total of 207 patients were randomized, of whom 175 were men (85%), and the median (range) age was 61 (23-78) years. The median follow-up duration was 58.2 (95% CI, 56.5-63.8) months. The 5-year OS was 59% (95% CI, 48%-68%) in the HMIE group and 47% (95% CI, 37%-57%) in the open esophagectomy group (hazard ratio [HR], 0.71; 95% CI, 0.48-1.06). The 5-year DFS was 52% (95% CI, 42%-61%) in the HMIE group vs 44% (95% CI, 34%-53%) in the open esophagectomy group (HR, 0.81; 95% CI, 0.55-1.17). No statistically significant difference in recurrence rate or location was found between groups. In a multivariable analysis, major intraoperative and postoperative complications (HR, 2.21; 95% CI, 1.41-3.45; P < .001) and major pulmonary complications (HR, 1.94; 95% CI, 1.21-3.10; P = .005) were identified as risk factors associated with decreased OS. Similarly, multivariable analysis of DFS identified overall intraoperative and postoperative complications (HR, 1.93; 95% CI, 1.28-2.90; P = .002) and major pulmonary complications (HR, 1.85; 95% CI, 1.19-2.86; P = .006) as risk factors.Conclusions and relevanceThis study found no difference in long-term survival between the HMIE and open esophagectomy groups. Major postoperative overall complications and pulmonary complications appeared to be independent risk factors in decreased OS and DFS, providing additional evidence that HMIE may be associated with improved oncological results compared with open esophagectomy primarily because of a reduction in postoperative complications.Trial registrationClinicalTrials.gov Identifier: NCT00937456.
| S-EPMC7890455 | biostudies-literature