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Postoperative Complications clinical trials

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NCT ID: NCT06404892 Not yet recruiting - Clinical trials for Postoperative Complications

ARISCAT, ASA and LAS VEGAS Risk Scores and the Incidence of Postoperative Pulmonary Complications in Thoracic Surgery

Start date: July 1, 2024
Phase:
Study type: Observational

Postoperative pulmonary complications (PPC) are among the main complications after the anesthetic-surgical procedure. It can be said that thoracic surgery results in impaired respiratory function in the postoperatively, due to the decrease in lung volumes and capacities (the vital capacity decreases by approximately 50-60% and functional residual capacity decreases by approximately 30% in the first 24 hours after surgery) diaphragm dysfunction, gas exchange impaired, cough and ineffective mucociliary clearance. Thus, our hypothesis is that the application of preoperative risk scores normally used for non-cardiac and non-thoracic surgeries may be effective on the predictability of the occurrence of CPP in patients undergoing ventilation single-lung. This is a prospective observational study in order to evaluate the performance of the ASA, ARISCAT and LAS VEGAS risk scores for predict the occurrence of postoperative pulmonary complications (PPC) in patients undergoing thoracic surgery with single-lung ventilation.

NCT ID: NCT06391632 Recruiting - Clinical trials for Postoperative Complications

Construction of a Prediction Model for MACCE in Elderly Patients After Elective Non-cardiac Surgery

Start date: March 1, 2023
Phase:
Study type: Observational

Severe cardiovascular and cerebrovascular complications, including cardiac death, non-fatal angina/myocardial infarction, non-fatal heart failure, stroke, severe arrhythmia, etc., are one of the main types of postoperative complications in elderly patients, and are also the main causes of perioperative death in elderly patients. With the aging population and the large proportion of elderly patients undergoing non-cardiac surgery, it is increasingly important to establish a prediction model for postoperative severe cardiovascular and cerebrovascular events in elderly patients undergoing noncardiac surgery.

NCT ID: NCT06391060 Completed - Rectal Cancer Clinical Trials

Gender Differences in Robotic Surgery for Rectal Cancer: a Retrospective Study

Start date: July 15, 2021
Phase:
Study type: Observational

Objective: To investigate gender-based differences in outcomes following robotic surgery for rectal cancer. Methods: A retrospective study was conducted on 155 patients (82 males, 73 females) who underwent robotic surgery for rectal cancer. Demographic, pre-operative, operative, and post-operative data were collected and analyzed. Pre-operative study: All patients underwent a standardized pre-operative work-up, which included a physical examination, comprehensive colonoscopy with biopsy, rigid rectoscopy, pelvic magnetic resonance imaging (MRI) scan, computed tomography (CT) of the thorax and abdomen, and measurement of carcinoembryonic antigen (CEA) levels. Tumor staging followed the TNM staging criteria (American Joint Committee on Cancer), with the T and N stages determined by the most advanced findings from any imaging modality Data collected: Retrospective evaluation and comparison of demographic characteristics, pre-operative TNM stage, distance from anal verge, tumor size, tumor grade, American Society of Anesthesiologists (ASA) score, and body mass index (BMI) were conducted among both patient groups. Peri-operative and post-operative data, including morbidity and mortality, were assessed, alongside parameters such as distal resection margin (DRM), proximal resection margin (PRM), harvested lymph nodes (HLN), and Clavien-Dindo Classification (CDC) scores. Diagnosis of anastomotic leakage was confirmed by clinical suspicion (e.g., changes in drainage, fever, abdominal pain) and further validated through contrast enema observed during follow-up computed tomography (CT). Hospital stay and readmission rates were monitored for up to 90 days post-surgery. Post-operative follow-up: Post-operative outcomes encompassed operative duration, estimated blood loss, time to first flatus passage, duration of liquid diet, and length of hospital stay following surgery. Operative duration comprised the time from initial skin incision to closure, including the time needed for robotic surgery docking and undocking. Upon experiencing initial flatulence, patients transitioned to a liquid diet. Hospital stay duration was measured from the time of surgery to discharge. The overall cost of surgery, including surgical procedures, anesthesia, medications, and post-operative care, was considered in the total expenditure analysis.

NCT ID: NCT06386354 Not yet recruiting - Clinical trials for Postoperative Complications

Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications

Porcerito
Start date: May 1, 2024
Phase:
Study type: Observational

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient.

NCT ID: NCT06385912 Completed - Ovarian Cancer Clinical Trials

Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer

Start date: July 1, 2006
Phase:
Study type: Observational

The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is: Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy? The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question.

NCT ID: NCT06378853 Completed - Pancreatic Cancer Clinical Trials

Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients

Start date: January 1, 2019
Phase:
Study type: Observational

By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients.

NCT ID: NCT06378073 Active, not recruiting - Clinical trials for Surgery-Complications

Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups. In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS"

NCT ID: NCT06372912 Recruiting - Clinical trials for Bariatric Surgery Candidate

Early Postoperative Complications in Patients Undergoing Bariatric Surgery

Start date: April 1, 2024
Phase:
Study type: Observational

This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery.

NCT ID: NCT06355362 Not yet recruiting - High-risk Surgery Clinical Trials

Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality

HeCoMo
Start date: May 1, 2024
Phase:
Study type: Observational

Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature. The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic. In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study. In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities.

NCT ID: NCT06351475 Not yet recruiting - Clinical trials for Postoperative Complications

Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

ALBUCHIP
Start date: September 2024
Phase: N/A
Study type: Interventional

Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day. Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial. Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence. Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial. Intervention - 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery. - Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned. Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28 Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study. Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery.