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Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial.
Aaen, AA, Voldby, AW, Storm, N, Kildsig, J, Hansen, EG, Zimmermann-Nielsen, E, Jensen, KM, Tibæk, P, Mortensen, A, Møller, AM, et al
British journal of anaesthesia. 2021;(4):521-531
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Abstract
BACKGROUND More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group). METHODS In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications. RESULTS In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found. CONCLUSION Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay. CLINICAL TRIAL REGISTRATION EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).
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Preoperative carbohydrate loading and intraoperative goal-directed fluid therapy for elderly patients undergoing open gastrointestinal surgery: a prospective randomized controlled trial.
Liu, X, Zhang, P, Liu, MX, Ma, JL, Wei, XC, Fan, D
BMC anesthesiology. 2021;(1):157
Abstract
BACKGROUND The effect of a combination of a goal-directed fluid protocol and preoperative carbohydrate loading on postoperative complications in elderly patients still remains unknown. Therefore, we designed this trial to evaluate the relative impact of preoperative carbohydrate loading and intraoperative goal-directed fluid therapy versus conventional fluid therapy (CFT) on clinical outcomes in elderly patients following gastrointestinal surgery. METHODS This prospective randomized controlled trial with 120 patients over 65 years undergoing gastrointestinal surgery were randomized into a CFT group (n = 60) with traditional methods of fasting and water-deprivation, and a GDFT group (n = 60) with carbohydrate (200 ml) loading 2 h before surgery. The CFT group underwent routine monitoring during surgery, however, the GDFT group was conducted by a Vigileo/FloTrac monitor with cardiac index (CI), stroke volume variation (SVV), and mean arterial pressure (MAP). For all patients, demographic data, intraoperative parameters and postoperative outcomes were recorded. RESULTS Patients in the GDFT group received significantly less crystalloids fluid (1111 ± 442.9 ml vs 1411 ± 412.6 ml; p < 0.001) and produced significantly less urine output (200 ml [150-300] vs 400 ml [290-500]; p < 0.001) as compared to the CFT group. Moreover, GDFT was associated with a shorter average time to first flatus (56 ± 14.1 h vs 64 ± 22.3 h; p = 0.002) and oral intake (72 ± 16.9 h vs 85 ± 26.8 h; p = 0.011), as well as a reduction in the rate of postoperative complications (15 (25.0%) vs 29 (48.3%) patients; p = 0.013). However, postoperative hospitalization or hospitalization expenses were similar between groups (p > 0.05). CONCLUSIONS Focused on elderly patients undergoing open gastrointestinal surgery, we found perioperative fluid optimisation may be associated with improvement of bowel function and a lower incidence of postoperative complications. TRIAL REGISTRATION ChiCTR, ChiCTR1800018227 . Registered 6 September 2018 - Retrospectively registered.
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Findings of a feasibility study of pre-operative pulmonary rehabilitation to reduce post-operative pulmonary complications in people with chronic obstructive pulmonary disease scheduled for major abdominal surgery.
Marlow, LL, Lee, AHY, Hedley, E, Grocott, MP, Steiner, MC, Young, JD, Rahman, NM, Snowden, CP, Pattinson, KTS
F1000Research. 2020;:172
Abstract
Background: Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of complications and death following surgery. Pulmonary complications are particularly prominent. Pulmonary rehabilitation is a course of physical exercise and education that helps people with COPD manage their condition. Although proven to improve health outcomes in patients with stable COPD, it has never been formally tested as a pre-surgical intervention in patients scheduled for non-cardiothoracic surgery. If a beneficial effect were to be demonstrated, pulmonary rehabilitation for pre-surgical patients with COPD might be rapidly implemented across the National Health Service, as pulmonary rehabilitation courses are already well established across much of the United Kingdom (UK). Methods: We performed a feasibility study to test study procedures and barriers to identification and recruitment to a randomised controlled trial testing whether pulmonary rehabilitation, delivered before major abdominal surgery in a population of people with COPD, would reduce the incidence of post-operative pulmonary complications. This study was run in two UK centres (Oxford and Newcastle upon Tyne). Results: We determined that a full randomised controlled trial would not be feasible, due to failure to identify and recruit participants. We identified an unmet need to identify more effectively patients with COPD earlier in the surgical pathway. Service evaluations suggested that barriers to identification and recruitment would likely be the same across other UK hospitals. Conclusions: Although pulmonary rehabilitation is a potentially beneficial intervention to prevent post-operative pulmonary complications, a randomised controlled trial is unlikely to recruit sufficient participants to answer our study question conclusively at the present time, when spirometry is not automatically conducted in all patients planned for surgery. As pulmonary rehabilitation is a recommended treatment for all people with COPD, alternative study methods combined with earlier identification of candidate patients in the surgical pathway should be considered. Trial registration: ISRCTN29696295, 31/08/2017.
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Combined epidural-general anaesthesia vs general anaesthesia in neonatal gastrointestinal surgery: A randomized controlled trial.
Gannam-Somri, L, Matter, I, Hadjittofi, C, Vaida, S, Khalaily, H, Hossein, J, Somri, M
Acta anaesthesiologica Scandinavica. 2020;(1):34-40
Abstract
BACKGROUND Post-operative ileus is a frequent complication of gastrointestinal surgery under general anaesthesia. The aim of this study was to investigate whether combined epidural-general anaesthesia is associated with expedited gastrointestinal function recovery in neonates undergoing elective gastrointestinal surgery. METHODS A randomized controlled trial including 60 neonates who underwent gastrointestinal surgery at a university hospital was performed. Thirty neonates received combined epidural-general anaesthesia (CEGA), and 30 neonates received general anaesthesia (GA) alone. The primary outcome was the post-operative time to tolerance of full enteral nutrition. The secondary outcomes were the post-operative time defaecation, the duration of nasogastric drainage, and infections. RESULTS After excluding two neonates from the CEGA group, where repeated attempts at epidural catheterization were unsuccessful, a total of 58 patients completed the study (CEGA: 28; GA: 30). Full enteral nutrition was tolerated earlier in CEGA vs the GA group (4.0 vs 8.0 days; P = .0001). Time to defaecation was shorter in the CEGA group (3.5 vs 5.0 days; P = .0001). Duration of nasogastric drainage was similar between groups (7.0 vs 7.0 days; P = .9502). Fewer patients in the CEGA group experienced post-operative infection (35.7% vs 60.0%; P = .038). CONCLUSION Combined epidural-general anaesthesia is associated with expedited gastrointestinal function recovery and a lower infection risk after gastrointestinal surgery in neonates.
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Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation.
van Rooijen, S, Carli, F, Dalton, S, Thomas, G, Bojesen, R, Le Guen, M, Barizien, N, Awasthi, R, Minnella, E, Beijer, S, et al
BMC cancer. 2019;(1):98
Abstract
BACKGROUND Colorectal cancer (CRC) is the second most prevalent type of cancer in the world. Surgery is the only curative option. However, postoperative complications occur in up to 50% of patients and are associated with higher morbidity and mortality rates, lower health related quality of life (HRQoL) and increased expenditure in health care. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Traditional approaches have targeted the postoperative period for rehabilitation and lifestyle changes. However, recent evidence shows that the preoperative period might be the optimal moment for intervention. This study will determine the impact of multimodal prehabilitation on patients' functional capacity and postoperative complications. METHODS/DESIGN This international multicenter, prospective, randomized controlled trial will include 714 patients undergoing colorectal surgery for cancer. Patients will be allocated to the intervention group, which will receive 4 weeks of prehabilitation (group 1, prehab), or the control group, which will receive no prehabilitation (group 2, no prehab). Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. The primary outcomes for measurement will be functional capacity (as assessed using the six-minute walk test (6MWT)) and postoperative status determined with the Comprehensive Complication Index (CCI). Secondary outcomes will include HRQoL, length of hospital stay (LOS) and a cost-effectiveness analysis. DISCUSSION Multimodal prehabilitation is expected to enhance patients' functional capacity and to reduce postoperative complications. It may therefore result in increased survival and improved HRQoL. This is the first international multicenter study investigating multimodal prehabilitation for patients undergoing colorectal surgery for cancer. TRIAL REGISTRATION Trial Registry: NTR5947 - date of registration: 1 August 2016.
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Comparison of three digestive tract reconstruction methods for the treatment of Siewert II and III adenocarcinoma of esophagogastric junction: a prospective, randomized controlled study.
Li, Z, Dong, J, Huang, Q, Zhang, W, Tao, K
World journal of surgical oncology. 2019;(1):209
Abstract
BACKGROUND The incidence of adenocarcinoma of esophagogastric junction (AEG) has recently risen worldwide, including in Eastern Asia. The aim of the study was to explore the short-term and long-term clinical efficacy of piggyback jejunal interposition reconstruction single-tract reconstruction (PJIRSTR), piggyback jejunal interposition reconstruction double-tract reconstruction (PJIRDTR), and total gastrectomy esophageal jejunal Roux-en-Y anastomosis (TGRY) for the treatment of Siewert II and III AEG patients. METHODS A total of 300 Siewert II and III AEG patients admitted to Shanxi Tumor Hospital from June 2015 to December 2017 were prospectively selected. Patients were randomly divided into PJIRSTR group (n = 98), PJIRDTR group (n = 103), and TGRY group (n = 99) using the random number table method. RESULTS There were no statistically significant differences in total operation time, intraoperative blood loss, time of first anal exhaust, and postoperative hospital stay among the three groups (F = 2.526, 0.457, 0.234, 0.453; P > 0.05). The reconstruction time of PJIRSTR group and PJIRDTR group was longer than that of TGRY group (P < 0.01). There were no significant differences in cases of anastomotic leakage, anastomotic bleeding, abdominal infection, incision infection, ileus, and dumping syndrome in three groups (P > 0.05). The incidence of reflux esophagitis at 3, 6, 12, and 18 months after surgery in the PJIRSTR group and the PJIRDTR group were significantly lower than TGRY group in the same period (P < 0.05). Compared with PJIRDTR group and TGRY group, PJIRSTR group had a small fluctuation range of postoperative nutrition indexes and had basically recovered to the preoperative level at 18 months. Four patients of Visick grade IV presented in TGRY group 18 months postoperatively, which was significantly higher compared with the other two groups. CONCLUSION Compared with PJIRDTR and TGRY, PJIRSTR can significantly reduce the incidence of postoperative reflux esophagitis and improve the long-term nutritional status of patients. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR-IIR-16007733. Registered 07 November 2015 - Retrospectively registered, http://www.chictr.org.cn/searchproj.aspx.
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Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials.
Gillis, C, Fenton, TR, Sajobi, TT, Minnella, EM, Awasthi, R, Loiselle, SÈ, Liberman, AS, Stein, B, Charlebois, P, Carli, F
Clinical nutrition (Edinburgh, Scotland). 2019;(3):1053-1060
Abstract
BACKGROUND & AIMS Preservation of lean body mass is an important cancer care objective. The capacity for prehabilitation interventions to modulate the lean body mass (LBM) of colorectal cancer patients before and after surgery is unknown. METHODS A pooled analysis of two randomized controlled trials of trimodal prehabilitation vs. trimodal rehabilitation at a single university-affiliated tertiary center employing Enhanced Recovery After Surgery (ERAS) care was conducted. The prehabilitation interventions included exercise, nutrition, and anxiety-reduction elements that began approximately four weeks before surgery and continued for eight weeks after surgery. The rehabilitation interventions were identical to the prehabilitation interventions but were initiated only after surgery. Body composition, measured using multifrequency bioelectrical impedance analysis, was recorded at baseline, pre-surgery, 4 and 8 weeks after surgery. The primary outcome was change in LBM before and after colorectal surgery for cancer. A mixed effects regression model was used to estimate changes in body mass and body composition over time controlling for age, sex, baseline body mass index (BMI), baseline six-minute walk test (6MWT), and postoperative compliance to the interventions. NCT02586701 &NCT01356264. RESULTS Pooled data included 76 patients who followed prehabilitation and 63 patients who followed rehabilitation (n = 139). Neither group experienced changes in preoperative LBM. Compared to rehabilitated patients, prehabilitated patients had significantly more absolute and relative LBM at four and eight-weeks post-surgery in models controlling for age, sex, baseline BMI, baseline 6MWT, and compliance to the postoperative intervention. CONCLUSION Trimodal prehabilitation attenuated the post-surgical LBM loss compared to the loss observed in patients who received the rehabilitation intervention. Patients who receive neither intervention (i.e., standard of care) would be likely to lose more LBM. Offering a prehabilitation program to colorectal cancer patients awaiting resection is a useful strategy to mitigate the impact of the surgical stress response on lean tissue in an ERAS setting, and, in turn, might have a positive impact on the cancer care course. CLINICAL TRIAL REGISTRATION NCT02586701 &NCT01356264 (clinicaltrials.gov).
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Supervised exercise training with multimodal pre-habilitation leads to earlier functional recovery following colorectal cancer resection.
Awasthi, R, Minnella, EM, Ferreira, V, Ramanakumar, AV, Scheede-Bergdahl, C, Carli, F
Acta anaesthesiologica Scandinavica. 2019;(4):461-467
Abstract
BACKGROUND Exercise training is a component of the pre-habilitation program. While in one previous study the training was home-based, in a subsequent investigation it was supervised in hospital. The hypothesis of this secondary analysis of the two studies was to determine whether supervised exercise further accelerates the return to baseline walking ability. METHODS Data from two consecutive randomized control trials (RCT) comparing pre-habilitation to the rehabilitation of cancer patients scheduled for colorectal surgery were pooled for analysis. The interventions were similar and included home-based exercise training, nutritional counseling and protein supplementation, and relaxation techniques administered either before surgery (pre-habilitation) or after surgery (rehabilitation). Patients in the second RCT received additional supervised exercise sessions. Functional capacity was assessed with the 6-minute walk test (6 MWT) at baseline, before surgery, and at 4 and 8 weeks after surgery. Adjusted logistic regression was used to determine the improvement of the 6-minute walk distance (6MWD). RESULTS Baseline mean 6MWD of 63 patients in the supervised group was 465.1 m (SD, 115), and that of 77 patients in the nonsupervised group was 407.8 m (SD, 109) (P < 0.01). Perioperative supervised exercise training enhanced further functional capacity and muscle strength when compared with the nonsupervised group (P < 0.01). Those receiving exercise supervision had over two times higher chances to return to baseline after surgery. Supervised pre-habilitation was the best combination (4 weeks OR = 7.71, and at 8 weeks OR = 8.62). CONCLUSION Supervised exercise training leads to meaningful changes in functional capacity thus accelerating the postoperative return to baseline activities.
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Acid/base alterations during major abdominal surgery: 6% hydroxyethyl starch infusion versus 5% albumin.
Kwak, HJ, Lim, OK, Baik, JM, Jo, YY
Korean journal of anesthesiology. 2018;(6):459-466
Abstract
BACKGROUND To compare the effects of intraoperative infusions of balanced electrolyte solution (BES)-based hydroxyethyl starch (HES) and saline-based albumin on metabolic acidosis and acid/base changes during major abdominal surgery conducted using Stewart's approach. METHODS Forty patients, aged 20-65 years, undergoing major abdominal surgery, were randomly assigned to the HES group (n = 20; received 500 ml of BES-based 6% HES 130/0.4) or the albumin group (n = 20; received 500 ml of normal saline-based 5% albumin). Acid-base parameters were measured and calculated using results obtained from arterial blood samples taken after anesthesia induction (T1), 2 hours after surgery commencement (T2), immediately after surgery (T3), and 1 hour after arriving at a postanesthetic care unit (T4). RESULTS Arterial pH in the HES group was significantly higher than that in the albumin group at T3 (7.40 ± 0.04 vs. 7.38 ± 0.04, P = 0.043), and pH values exhibited significant intergroup difference over time (P = 0.002). Arterial pH was significantly lower at T3 and T4 in the HES group and at T2, T3, and T4 in the albumin group than at T1. Apparent strong ion difference (SIDa) was significantly lower at T2, T3, and T4 than at T1 in both groups. Total plasma weak nonvolatile acid (ATOT) was significantly lower in the HES group than in the albumin group at T2, T3 and T4 and exhibited a significant intergroup difference over time (P < 0.001). CONCLUSIONS BES-based 6% HES infusion was associated with lower arterial pH values at the end of surgery than saline-based 5% albumin infusion, but neither colloid caused clinically significant metabolic acidosis (defined as an arterial pH < 7.35).
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Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial.
Senéjoux, A, Siproudhis, L, Abramowitz, L, Munoz-Bongrand, N, Desseaux, K, Bouguen, G, Bourreille, A, Dewit, O, Stefanescu, C, Vernier, G, et al
Journal of Crohn's & colitis. 2016;(2):141-8
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Abstract
BACKGROUND AND AIMS Anal fistula plug [AFP] is a bioabsorbable bioprosthesis used in ano-perineal fistula treatment. We aimed to assess efficacy and safety of AFP in fistulising ano-perineal Crohn's disease [FAP-CD]. METHODS In a multicentre, open-label, randomised controlled trial we compared seton removal alone [control group] with AFP insertion [AFP group] in 106 Crohn's disease patients with non- or mildly active disease having at least one ano-perineal fistula tract drained for more than 1 month. Patients with abscess [collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12. RESULTS In all, 54 patients were randomised to AFP group [control group 52]. Median fistula duration was 23 [10-53] months. Median Crohn's Disease Activity Index at baseline was 81 [45-135]. Fistula closure at Week 12 was achieved in 31.5% patients in the AFP group and in 23.1 % in the control group (relative risk [RR] stratified on AGA classification: 1.31; 95% confidence interval: 0.59-4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 15.4% and 25.6% in controls, respectively [RR of success = 2.17 in complex fistula vs RR = 1.20 in simple fistula; p = 0.45]. Concerning safety, at Week 12, 17 patients developed at least one adverse event in the AFP group vs 8 in the controls [p = 0.07]. CONCLUSION AFP is not more effective than seton removal alone to achieve FAP-CD closure.