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1.
Int J Colorectal Dis ; 39(1): 65, 2024 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-38700747

RESUMO

PURPOSE: Remote ischemic preconditioning (RIPC) reportedly reduces ischemia‒reperfusion injury (IRI) in various organ systems. In addition to tension and technical factors, ischemia is a common cause of anastomotic leakage (AL) after rectal resection. The aim of this pilot study was to investigate the potentially protective effect of RIPC on anastomotic healing and to determine the effect size to facilitate the development of a subsequent confirmatory trial. MATERIALS AND METHODS: Fifty-four patients with rectal cancer (RC) who underwent anterior resection were enrolled in this prospectively registered (DRKS0001894) pilot randomized controlled triple-blinded monocenter trial at the Department of Surgery, University Medicine Mannheim, Mannheim, Germany, between 10/12/2019 and 19/06/2022. The primary endpoint was AL within 30 days after surgery. The secondary endpoints were perioperative morbidity and mortality, reintervention, hospital stay, readmission and biomarkers of ischemia‒reperfusion injury (vascular endothelial growth factor, VEGF) and cell death (high mobility group box 1 protein, HMGB1). RIPC was induced through three 10-min cycles of alternating ischemia and reperfusion to the upper extremity. RESULTS: Of the 207 patients assessed, 153 were excluded, leaving 54 patients to be randomized to the RIPC or the sham-RIPC arm (27 each per arm). The mean age was 61 years, and the majority of patients were male (37:17 (68.5:31.5%)). Most of the patients underwent surgery after neoadjuvant therapy (29/54 (53.7%)) for adenocarcinoma (52/54 (96.3%)). The primary endpoint, AL, occurred almost equally frequently in both arms (RIPC arm: 4/25 (16%), sham arm: 4/26 (15.4%), p = 1.000). The secondary outcomes were comparable except for a greater rate of reintervention in the sham arm (9 (6-12) vs. 3 (1-5), p = 0.034). The median duration of endoscopic vacuum therapy was shorter in the RIPC arm (10.5 (10-11) vs. 38 (24-39) days, p = 0.083), although the difference was not statistically significant. CONCLUSION: A clinically relevant protective effect of RIPC on anastomotic healing after rectal resection cannot be assumed on the basis of these data.


Assuntos
Fístula Anastomótica , Precondicionamento Isquêmico , Neoplasias Retais , Humanos , Neoplasias Retais/cirurgia , Masculino , Projetos Piloto , Feminino , Fístula Anastomótica/etiologia , Fístula Anastomótica/prevenção & controle , Pessoa de Meia-Idade , Precondicionamento Isquêmico/métodos , Idoso , Traumatismo por Reperfusão/prevenção & controle , Traumatismo por Reperfusão/etiologia , Resultado do Tratamento
2.
Clin Nutr ESPEN ; 61: 181-188, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38777431

RESUMO

BACKGROUND & AIMS: Exploration whether Motivational Interviewing (MI) could be learned and implemented with ease within a surgical in-hospital setting and whether participation in the intervention led to significantly higher compliance with ERAS®-recommended protein intake goals. The individual healing process of many patients is delayed because they fail to cover their calorie requirement, which could be counteracted by a patient-centered conversational intervention that is new in perioperative practice. METHODS: This patient-blinded pilot-RCT included 60 patients (≥18 years) following the certified ERAS® bowel protocol for colorectal surgery between March and August 2022. Five perioperative MI interventions were conducted by two health employees certified to perform MI. Key endpoints were the number of protein shakes drunk, calories of proteins ingested and overall calorie intake. RESULTS: A total of 60 patients (34 men [56.7%]; mean [SD] age, 60.7 [13.3] years) were randomized. MI patient-group had significantly higher protein shake intake on all postoperative days except day 3. For days 0-3 MI group drank significantly more shakes overall (median 5.5 vs. 2.0; P = 0.004) and consumed more calories (median 1650.0 vs. 600.0 kcal; P = 0.004) and proteins (median 110.0 vs. 40.0 g; P = 0.005). Total calorie intake for each day by shakes and dietary intake was significantly higher in the MI-intervention group on day 2 (mean 1772.3 vs. 1358.9 kcal; P = 0.03). CONCLUSIONS: MI may contribute to improve compliance with nutritional goals in the certified ERAS® protocol by increasing protein and calorie intake. The findings suggest further investigation of MI to help patients achieve their perioperative nutrition goals in different clinical settings. TRIAL REGISTRATION: DRKS - Deutsches Register Klinischer Studien; DRKS-ID: DRKS00027863; https://drks.de/search/de/trial/DRKS00027863.


Assuntos
Procedimentos Cirúrgicos Eletivos , Recuperação Pós-Cirúrgica Melhorada , Entrevista Motivacional , Estado Nutricional , Humanos , Projetos Piloto , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Ingestão de Energia , Período Pós-Operatório , Cuidados Pós-Operatórios/métodos , Proteínas Alimentares/administração & dosagem , Objetivos
4.
Langenbecks Arch Surg ; 409(1): 134, 2024 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-38644386

RESUMO

PURPOSE: Early mobilization is an essential component of the Enhanced Recovery after Surgery (ERAS®)-pathway. However, a large percentage of patients fail to achieve the ERAS® recommended goal (360 min out of bed from post-operative day 1/POD1). Motivational Interviewing (MI) is an evidence-based type of patient-centered consultation to promote intrinsic motivation. This study aims to evaluate if MI can improve postoperative mobilization. METHODS: This two-arm, patient-blinded pilot randomized controlled trial included ERAS®-patients undergoing elective bowel resections. Conversations were validated by MI Treatment Integrity. Two validated motion sensors (movisens) and self-assessments were used to measure mobilization (POD1-POD3: Time out of bed, time on feet and step count). RESULTS: 97 patients were screened, 60 finally included and randomized. Cumulatively across POD1-3, the intervention group (IG) was longer out of bed than the control group (CG) (median: 685 vs. 420 min; p=0.022). The IG achieved the ERAS®-goal of 360 min/day more frequently across POD1-3 (27.4% vs. 10.61%; p=0.013). Time on feet was 131.5 min/day (median per POD) in IG vs. 95.8 min/day in the CG (p=0.212), step count was 1347 in IG vs. 754 steps/day in CG (p=0.298). CONCLUSION: MI could be conducted low threshold and was well accepted by patients. MI can improve mobilization in the context of ERAS®. Despite better performance, it should be noted that only 27.4% of the IG reached the ERAS®-compliance goal of 360 min/day. The findings of this pilot study stipulate to further test the promising perioperative effects of MI within a multicenter superiority trial. REGISTRATION: This study was registered prospectively in the German Clinical Trials Register on 25.02.2022. Trial registration number is "DRKS00027863".


Assuntos
Deambulação Precoce , Procedimentos Cirúrgicos Eletivos , Recuperação Pós-Cirúrgica Melhorada , Entrevista Motivacional , Humanos , Projetos Piloto , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Método Simples-Cego
5.
JAMA Surg ; 159(5): 484-492, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38381428

RESUMO

Importance: Surgical site infections frequently occur after open abdominal surgery. Intraoperative wound irrigation as a preventive measure is a common practice worldwide, although evidence supporting this practice is lacking. Objective: To evaluate the preventive effect of intraoperative wound irrigation with polyhexanide solution. Design, Setting, and Participants: The Intraoperative Wound Irrigation to Prevent Surgical Site Infection After Laparotomy (IOWISI) trial was a multicenter, 3-armed, randomized clinical trial. Patients and outcome assessors were blinded to the intervention. The clinical trial was conducted in 12 university and general hospitals in Germany from September 2017 to December 2021 with 30-day follow-up. Adult patients undergoing laparotomy were eligible for inclusion. The main exclusion criteria were clean laparoscopic procedures and the inability to provide consent. Of 11 700 screened, 689 were included and 557 completed the trial; 689 were included in the intention-to-treat and safety analysis. Interventions: Randomization was performed online (3:3:1 allocation) to polyhexanide 0.04%, saline, or no irrigation (control) of the operative wound before closure. Main Outcome and Measures: The primary end point was surgical site infection within 30 postoperative days according to the US Centers for Disease Control and Prevention definition. Results: Among the 689 patients included, 402 were male and 287 were female. The median (range) age was 65.9 (18.5-94.9) years. Participants were randomized to either wound irrigation with polyhexanide (n = 292), saline (n = 295), or no irrigation (n = 102). The procedures were classified as clean contaminated in 92 cases (8%). The surgical site infection incidence was 11.8% overall (81 of 689), 10.6% in the polyhexanide arm (31 of 292), 12.5% in the saline arm (37 of 295), and 12.8% in the no irrigation arm (13 of 102). Irrigation with polyhexanide was not statistically superior to no irrigation or saline irrigation (hazard ratio [HR], 1.23; 95% CI, 0.64-2.36 vs HR, 1.19; 95% CI, 0.74-1.94; P = .47). The incidence of serious adverse events did not differ among the 3 groups. Conclusions and Relevance: In this study, intraoperative wound irrigation with polyhexanide solution did not reduce surgical site infection incidence in clean-contaminated open abdominal surgical procedures compared to saline or no irrigation. More clinical trials are warranted to evaluate the potential benefit in contaminated and septic procedures, including the emergency setting. Trial Registration: drks.de Identifier: DRKS00012251.


Assuntos
Biguanidas , Laparotomia , Infecção da Ferida Cirúrgica , Irrigação Terapêutica , Humanos , Infecção da Ferida Cirúrgica/prevenção & controle , Masculino , Feminino , Laparotomia/efeitos adversos , Pessoa de Meia-Idade , Biguanidas/uso terapêutico , Biguanidas/administração & dosagem , Idoso , Cuidados Intraoperatórios/métodos , Adulto
6.
Int J Colorectal Dis ; 39(1): 14, 2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-38168001

RESUMO

PURPOSE: This study aimed to investigate the surgical short- and mid-term outcomes, as well as the impact on quality of life and recovery, following oncological right hemicolectomy. To accomplish this, three patient cohorts were examined, which included laparotomy OA), laparoscopy with intracorporeal anastomosis (LIA), and laparoscopy with extracorporeal anastomosis (LEA). Our hypothesis was that the group undergoing intracorporeal anastomosis would demonstrate superior outcomes compared to the other cohorts. METHODS: The analysis included a total of 135 patients who were enrolled between 2015 and 2020. In addition to retrospectively collected data, we conducted follow-up surveys using a validated Gastrointestinal Quality of Life Index (GIQLI) questionnaire and semi-structured interviews. These surveys were conducted between July and September 2021 to gather comprehensive information regarding the patients' quality of life. RESULTS: The study cohort was divided into OA (n = 67), LEA (n = 14), and LIA (n = 54). The duration of surgery was significantly longer in the laparoscopic groups (median = 200.5 (LEA) and 184.0 (LIA) min vs 170.0 min (OA); p = 0.007), while the length of hospital stay was significantly shorter (median = 6.0 and 7.0 days vs 9.0 days; p = 0.005). The overall postoperative complication rate was significantly higher in the laparotomy group compared to the intracorporeal group (64.2% vs 35.2%; p = 0.006), with the extracorporeal group having a rate of 42.9%. Reoperation within 30 days occurred exclusively in the open surgery group (n = 9; 13.43%; p = 0.007). The overall response rate to the survey was 75%. Overall, the GIQLI score was comparable among the three groups, and there were no significant differences in the questions related to recovery, regained function, and contentment. CONCLUSION: The laparoscopic approaches demonstrated significantly lower complication rates compared to laparotomy, while no significant differences were observed between the two laparoscopic techniques.


Assuntos
Neoplasias do Colo , Laparoscopia , Humanos , Estudos Retrospectivos , Qualidade de Vida , Colectomia/efeitos adversos , Colectomia/métodos , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Anastomose Cirúrgica/efeitos adversos , Anastomose Cirúrgica/métodos , Neoplasias do Colo/cirurgia , Resultado do Tratamento
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