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Preoperative Single-Dose Intravenous Iron Formulation to Reduce Postsurgical Complications in Patients Undergoing Major Abdominal Surgery: A Randomized Control Trial Feasibility Study (PIRCAS Trial Pilot).

ABSTRACT: Background Preoperative anemia is associated with an increased need for blood transfusion, complications, and prolonged hospital stay. Iron deficiency anemia (IDA) may be treated with oral or intravenous (IV) iron. IV iron repletes iron stores more rapidly. Its impact on perioperative blood transfusion, postoperative complications, patients' recovery, and long-term quality of life is unclear. Newer agents, such as ferric carboxymaltose (FCM), are costly but have higher maximum approved doses and a very low incidence of anaphylactic-type reactions. This study aims to explore the feasibility of a randomized control trial to compare the preoperative treatment of IDA with IV FCM versus oral ferrous fumarate, in patients undergoing elective major abdominal surgery. Experimental design This is an open-label pilot randomized controlled trial. A total of 30 adults with IDA scheduled for elective major abdominal surgery were recruited for the study. They were randomized into two groups to receive either oral iron or IV FCM. Primary outcomes are defined as the time from enrollment to study drug administration, recruitment rate, and follow-up rate up to three months. Secondary outcomes are hemoglobin rise from recruitment to surgery, perioperative blood transfusion, postoperative complications, EQ-5D-3L scores at baseline, and three months and adverse events related to IV FCM therapy. Results All patients received study drugs within five days of enrollment; 30 patients were recruited within four months, 15 patients in each group. Two in each group were withdrawn for surgery postponement. All patients were followed up for three months and there was no crossover of patients. Per protocol, analysis was performed. No severe adverse events related to IV FCM therapy occurred. Both groups had similar baseline characteristics, similar hemoglobin rise from enrollment to the day of surgery [0.2 (+1.6) g/dL in the FCM group and 0.8 (+0.7) g/dL in the Oral Iron group, p=0.3] and similar mean units of perioperative blood transfused (recruitment to discharge) per patient [1.3 (+ 2.1) in the FCM group and 0.9 (+1.3) in the Oral Iron group, p=0.6]. Postoperatively, there was a similar hospital length of stay [11.5 (+13.6 days) in the FCM group and 9.0 (+9.8 days) in the Oral Iron group, p=0.6]; there were similar postoperative complications as reflected by the average Comprehensive Complication Index [12.8 (+19.6) in the FCM group and 22.6 (+30.7) in the Oral Iron group, p=0.3]; similar postoperative health-related quality of life as reflected by mean EQ-5D-3L scores at one month [70.4 (+21.8) in the FCM group and 84.5 (+12.1) in the Oral Iron group] and three months [80.0 (+18.4) in the FCM group and 85.9 (+10.7) in the Oral Iron group]. Conclusions A full-scale randomized controlled trial to evaluate the effectiveness of preoperative IV FCM compared to oral iron in patients with IDA undergoing major abdominal surgery is feasible.

SUBMITTER: Thin TN

PROVIDER: S-EPMC8452824 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPostoperative pulmonary complications (PPCs) have an impact on the recovery of adults after surgery. It is therefore important to establish whether preoperative respiratory rehabilitation can decrease the risk of PPCs and to identify adults who might benefit from respiratory rehabilitation.ObjectivesOur primary objective was to assess the effectiveness of preoperative inspiratory muscle training (IMT) on PPCs in adults undergoing cardiac or major abdominal surgery. We looked at all-cause mortality and adverse events.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to October 2014), EMBASE (1980 to October 2014), CINAHL (1982 to October 2014), LILACS (1982 to October 2014), and ISI Web of Science (1985 to October 2014). We did not impose any language restrictions.Selection criteriaWe included randomized controlled trials that compared preoperative IMT and usual preoperative care for adults undergoing cardiac or major abdominal surgery.Data collection and analysisTwo or more review authors independently identified studies, assessed trial quality, and extracted data. We extracted the following information: study characteristics, participant characteristics, intervention details, and outcome measures. We contacted study authors for additional information in order to identify any unpublished data.Main resultsWe included 12 trials with 695 participants; five trials included participants awaiting elective cardiac surgery and seven trials included participants awaiting elective major abdominal surgery. All trials contained at least one domain judged to be at high or unclear risk of bias. Of greatest concern was the risk of bias associated with inadequate blinding, as it was impossible to blind participants due to the nature of the study designs. We could pool postoperative atelectasis in seven trials (443 participants) and postoperative pneumonia in 11 trials (675 participants) in a meta-analysis. Preoperative IMT was associated with a reduction of postoperative atelectasis and pneumonia, compared with usual care or non-exercise intervention (respectively; risk ratio (RR) 0.53, 95% confidence interval (CI) 0.34 to 0.82 and RR 0.45, 95% CI 0.26 to 0.77). We could pool all-cause mortality within postoperative period in seven trials (431 participants) in a meta-analysis. However, the effect of IMT on all-cause postoperative mortality is uncertain (RR 0.40, 95% CI 0.04 to 4.23). Eight trials reported the incidence of adverse events caused by IMT. All of these trials reported that there were no adverse events in both groups. We could pool the mean duration of hospital stay in six trials (424 participants) in a meta-analysis. Preoperative IMT was associated with reduced length of hospital stay (MD -1.33, 95% CI -2.53 to -0.13). According to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group guidelines for evaluating the impact of healthcare interventions, the overall quality of studies for the incidence of pneumonia was moderate, whereas the overall quality of studies for the incidence of atelectasis, all-cause postoperative death, adverse events, and duration of hospital stay was low or very low.Authors' conclusionsWe found evidence that preoperative IMT was associated with a reduction of postoperative atelectasis, pneumonia, and duration of hospital stay in adults undergoing cardiac and major abdominal surgery. The potential for overestimation of treatment effect due to lack of adequate blinding, small-study effects, and publication bias needs to be considered when interpreting the present findings.

Project description:ImportanceAs greater numbers of older patients seek elective surgery, one approach to preventing postoperative complications is enhanced assessment of risks during preoperative evaluation.ObjectiveTo determine whether a geriatric assessment tool can be implemented in a preoperative clinic and can estimate risk of postoperative complications.Design, setting, and participantsIn this prospective cohort study, patients 70 years of age or older were assessed in a preoperative clinic for elective surgery from July 9, 2008, to January 5, 2011. Patients were screened using the Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) tool developed for this study. Patients were assessed on 5 preoperative activities of daily living recommended by the American College of Surgeons (bathing, transferring, dressing, shopping, and meals), history of falling or gait impairment, and depressive symptoms (2-item Patient Health Questionnaire). Patients also underwent a brief cognitive examination (Mini-Cog) and gait and balance assessment (Timed Up and Go test). A novel question was also asked as to whether patients expected they could manage themselves alone after discharge. Comorbidities and work-related relative value units (categorized into low, moderate, and high tertiles) were also collected. Multivariable logistic regression was performed to estimate risk of postoperative complications. Sustainability of VESPA over time was also evaluated. Medical record review was performed from December 11, 2012, to October 2, 2015, and data analysis was performed from November 15, 2015, to May 18, 2016.Main outcomes and measuresPostoperative surgical and geriatric complications.ResultsOf the 770 patients evaluated, 736 (384 women and 352 men; mean [SD] age, 77.7 [5.7] years) underwent 740 operative procedures; of these patients, 711 had complete data for multivariable analysis. In our sample, 105 patients (14.3%) reported 1 or more difficulties with the 5 activities of daily living, and 270 of 707 patients (38.2%) foresaw themselves unable to manage self-care alone. A total of 131 of 740 patients had geriatric complications, and 114 of 740 patients had surgical complications; 187 of 740 patients (25.3%) had either geriatric or surgical complications. On multivariable analysis, the number of difficulties with activities of daily living (odds ratio [OR], 1.3; 95% CI, 1.0-1.6), anticipated difficulty with postoperative self-care (OR, 1.6; 95% CI, 1.0-2.2), Charlson Comorbidity score of 2 or more vs less than 2 (OR, 1.5; 95% CI, 1.0-2.3), male sex (OR, 1.6; 95% CI, 1.1-2.3), and work-related relative value units (moderate vs low: OR, 1.9; 95% CI, 1.1-3.3; high vs low: OR, 8.8; 95% CI, 5.3-14.5) were independently associated with postoperative complications (overall model area under the receiver operating characteristic curve, 0.77). With these results, a whole-point VESPA score used alone to estimate risk of complications also demonstrated excellent fit (area under the curve, 0.76).Conclusions and relevancePreoperative assessment of older geriatric patients is feasible in the general preoperative clinic and can help identify patients at higher risk of postoperative complications.

Project description:BackgroundPreoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes.MethodsIn a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants.FindingsOf 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints.InterpretationPreoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery.FundingUK National Institute of Health Research Health Technology Assessment Program.

Project description:OBJECTIVES:Incisional hernias are common complications of midline abdominal closure. The 'Hughes Repair' combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial. DESIGN AND SETTING:A feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery. PARTICIPANTS:Patients undergoing midline incisional surgery for resection of colorectal cancer. INTERVENTIONS:Comparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer. PRIMARY AND SECONDARY OUTCOMES:A 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used. RESULTS:A total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns. CONCLUSIONS:The feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee. TRIAL REGISTRATION NUMBER:ISRCTN 25616490.

Project description:BackgroundPatients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.MethodsIn this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. Patients' postoperative courses were followed for 1 year after the index operation. Effectiveness and safety outcomes were compared at a level of significance of 5% between the two techniques.ResultsA total of 100 out of 131 patients (76.3%) were evenly randomised to the small stitches and large stitches groups. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334). The overall comprehensive complication index was 14.4 ± 15.5 in the small stitches group and 19.9 ± 23.4 in the large stitches group (p = 0.168). Specifically, rates of surgical site infection (small stitches 30.0% versus large stitches 36.0%; p = 0.524) and burst abdomen (small stitches 4.0% versus large stitches 0.0%; p = 0.495) did not differ. After 1 year, incisional hernia rate was 7.5% in the small stitches group and 10.0% in the large stitches group (p > 0.999).DiscussionBoth abdominal wall closure techniques investigated in this trial were feasible in relaparotomy patients. This exploratory trial revealed no noticeable difference in the effectiveness or safety of the small stitches technique with Monomax® 2-0 versus the large stitches technique with PDS II® 1 loop. Therefore, surgeons should stay with their preferred suture technique in relaparotomy patients.Trial registrationDeutsches Register Klinischer Studien ( www.germanctr.de ): DRKS00013001.

Project description:OBJECTIVE:To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. DESIGN:Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. SETTING:Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. PARTICIPANTS:441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. INTERVENTIONS:Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. MAIN OUTCOME MEASURES:The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. RESULTS:The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected. CONCLUSION:In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

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Preoperative Single-Dose Intravenous Iron Formulation to Reduce Postsurgical Complications in Patients Undergoing Major Abdominal Surgery: A Randomized Control Trial Feasibility Study (PIRCAS Trial Pilot).

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