Dataset Information

A randomized trial of preoperative oral carbohydrates in abdominal surgery.

ABSTRACT:

Background

Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients.

Methods

A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and control. Visual analogue scale (VAS) scores for seven parameters (thirst, hunger, anxiety, mouth dryness, nausea, weakness and sleep quality) were recorded and compared for two different time periods (up to 24 h postoperatively and from 36 to 48 h postoperatively). The Simplified Acute Physiology Score changes (SAPS)-II between the three groups were also studied.

Results

There were 142 patients American Society of Anesthesiology (ASA) I or II enrolled in the study (CR?=?71 and CH?=?71). There were no significant differences in postoperative SAPS-II scores or lengths of hospital stay (LOS) between the groups. However, in CR patients, the degree of thirst was partially improved by drinking CRLDs (P?=?0.027). In CH patients, on the other hand, feelings of thirst, hunger, mouth dryness, nausea and weakness showed significant improvement (P?ConclusionOral administration of carbohydrate-rich liquid drinks (CRLDs) improves the well-being in patients undergoing CH, but the effect is less evident in patients undergoing CR. No significant improvements were seen in clinical status or in length of hospital stay in either group.

Trial registration

ANZCTR.org.au: ACTRN12614000995673 (registered on 16/09/2014).

SUBMITTER: Sada F

PROVIDER: S-EPMC4216365 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

A randomized trial of preoperative oral carbohydrates in abdominal surgery.

Sada Fatos F Krasniqi Avdyl A Hamza Astrit A Gecaj-Gashi Agreta A Bicaj Besnik B Kavaja Floren F

BMC anesthesiology 20141017

<h4>Background</h4>Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients.<h4>Methods</h4>A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, p ...[more]

PMID: 25364300

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Project description: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.

Project description:BackgroundRehabilitation strategies after abdominal surgery enhance recovery and improve outcome. A cornerstone of rehabilitation is respiratory physiotherapy with inspiratory muscle training to enhance pulmonary function. Pre-habilitation is the process of enhancing functional capacity before surgery in order to compensate for the stress of surgery and postoperative recovery. There is growing interest in deploying pre-habilitation interventions prior to surgery. The aim of this study is to assess the impact of preoperative inspiratory muscle training on postoperative overall morbidity. The question is, whether inspiratory muscle training prior to elective abdominal surgery reduces the number of postoperative complications and their severity grade.MethodsWe describe a prospective randomized-controlled single-centre trial in a tertiary referral centre. The primary outcome is the Comprehensive Complication Index (CCI) at 90 days after surgery. The CCI expresses morbidity on a continuous numeric scale from 0 (no complication) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity. In the intervention group, patients will be instructed by physiotherapists to perform inspiratory muscle training containing of 30 breaths twice a day for at least 2 weeks before surgery using Power®Breathe KHP2. Depending on the surgical schedule, training can be extended up to 6 weeks. In the control group, no preoperative inspiratory muscle training will be performed. After the operation, both groups receive the same physiotherapeutic support.DiscussionExisting data about preoperative inspiratory muscle training on postoperative complications are ambiguous and study protocols are often lacking a clear design and a clearly defined endpoint. Most studies consist of multi-stage concepts, comprehensively supervised and long-term interventions, whose implementation in clinical practice is hardly possible. There is a clear need for randomized-controlled studies with a simple protocol that can be easily transferred into clinical practice. This study examines the effortless adjustment of the common respiratory physiotherapy from currently postoperative to preoperative. The external measurement by the device eliminates the diary listing of patients' performances and allows the exercise adherence and thus the effect to be objectively recorded.Trial registrationClinicalTrials.gov NCT04558151 . Registered on September 15, 2020.

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Project description:BackgroundCurcumin, a popular herbal supplement from the plant turmeric, has prevented ischemic reperfusion and toxin-induced injury in many animal studies and a single-centre randomized human trial. We sought to test whether perioperative oral curcumin (compared with placebo) affects the inflammatory response and risk of postrepair complications after elective abdominal aortic aneurysm repair in humans.MethodsWe conducted a parallel-group, randomized, placebo-controlled trial of patients from 10 hospitals in Canada who were scheduled to undergo elective repair of an unruptured abdominal aortic aneurysm (November 2011 to November 2014). Patients in the treatment group received perioperative oral curcumin (2000-mg doses 8 times over 4 d). Patients, health care providers and local research staff were unaware of the treatment assignment. The primary outcomes were median concentrations of 4 bio markers indicating injury and inflammation (postoperative urine interleukin-18 and perioperative rise in serum creatinine, plasma N-terminal pro-B-type natriuretic peptide and plasma high-sensitivity C-reactive protein).ResultsBaseline characteristics were similar in the 2 groups (606 patients overall; median age 76 yr). More than 85% of patients in each group took more than 80% of their scheduled capsules. Neither curcumin nor placebo significantly affected any of the 4 biomarkers (p > 0.05 for all comparisons). Regarding the secondary outcomes, there was a higher risk of acute kidney injury with curcumin than with placebo (17% v. 10%, p = 0.01), but no between-group difference in the median length of hospital stay (5 v. 5 days, p > 0.9) or the risk of clinical events (9% v. 9%, p = 0.9).InterpretationCurcumin had no beneficial effects when used in elective abdominal aortic aneurysm repair. These findings emphasize the importance of testing turmeric and curcumin before espousing their health benefits, as is currently done in the popular media.Trial registrationClinicalTrials.gov, no. NCT01225094.

Dataset Information

A randomized trial of preoperative oral carbohydrates in abdominal surgery.

Background

Methods

Results

Trial registration

Publications

A randomized trial of preoperative oral carbohydrates in abdominal surgery.

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