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Perioperative Complication clinical trials

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NCT ID: NCT06077422 Recruiting - Pain, Postoperative Clinical Trials

Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain

Start date: January 11, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries.

NCT ID: NCT06065137 Recruiting - Hypersensitivity Clinical Trials

Standardised Drug Provocation Testing in Perioperative Hypersensitivity

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and outcome of systematic drug provocation testing with anaesthetics at therapeutic doses in adult patients undergoing diagnostic work-up for perioperative hypersensitivity.

NCT ID: NCT06049693 Completed - Endometrial Cancer Clinical Trials

Iron Prehabilitation in Endometrial Cancer

IROGYN
Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. In the present study the investigators will evaluate the impact of perioperative iron supplementation on the incidence of perioperative infections.

NCT ID: NCT06035627 Recruiting - Clinical trials for Surgical Site Infection

The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.

Start date: May 15, 2023
Phase:
Study type: Observational [Patient Registry]

There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled study will be planned in the future to examine the effect of IPH on SSI in patients who will undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery clinic and operating room of a university hospital. It will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.

NCT ID: NCT06003517 Recruiting - Clinical trials for Perioperative Complication

Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data

Start date: December 10, 2022
Phase:
Study type: Observational

Based on the data from the anesthesia record electronic system, patient safety incident (PSI) electronic reporting system and related PSI retrospective cohort in the past 10 years, this project intends to carry out structured and consistent (real world data)RWD processing, and conduct (real world evidence)RWE research related to perioperative safety and quality control in order to characterize the epidemiology of perioperative PSIs, explore the related factors, and construct a prediction model, and on the basis of which to construct a standardized platform for reporting and analysis of perioperative PSIs based on RWD. On this basis, a standardized platform for PSI reporting and analysis was constructed based on RWD.

NCT ID: NCT05936853 Active, not recruiting - Pediatric ALL Clinical Trials

The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA)

EPIVA
Start date: August 3, 2023
Phase: N/A
Study type: Interventional

More than half a million children have an anaesthetic each year in the UK. Though anaesthesia is usually thought to be safe and necessary to improve health, concerns remain the effects that the drugs used may have on brain development in children and the potential long-term consequences for health. The two techniques used to keep someone asleep during anaesthesia are either giving the appropriate drugs through a small plastic tube into a vein or introducing different drugs into the lungs in gas form. Gene expression is the process by which instructions in DNA are used to make products such as proteins. Anaesthetic drugs may change how a child's genes are expressed; a process called epigenetics. Studies have shown that different anaesthetic drugs can cause epigenetic changes in animals and affect the processing ability of their brains. This study will focus on children aged under 3 undergoing general anaesthesia for planned hypospadias surgery (a developmental condition where the look and function of the penis may not be completely normally). Participants will either receive their general anaesthetic in gas form or through directly into their veins - both techniques are commonly used. A small blood sample (between 1 and 2 teaspoons) will be collected at the start and end of the operation whilst under anaesthetic. Samples will be analysed to look for any changes in signals on DNA (epigenetic changes) and other markers. Further analysis may then look at other measures of gene expression and additional processes/markers that could be affected. There is relatively less medical research carried out in children and this work will show whether this type of study is possible in this age-group and provide information for future trials. It will help towards improving our understanding of the effects of anaesthesia ultimately help doctors and families make better informed decisions.

NCT ID: NCT05925998 Not yet recruiting - Clinical trials for Perioperative Complication

Mitochondrial Function in the Peri-operative Setting: an Observational Study

MITOSIS
Start date: July 5, 2023
Phase:
Study type: Observational

Complications after surgery are common and a burden for patients and health services. Therefore it is important that clinicians improve surgical outcomes. Mitochondria are the part of the body's cells that manage energy. Research has already shown that how our body's mitochondria behave can predict who survives in intensive care patients. The investigators think this could also predict who is more likely to develop complications after surgery. Therefore a study has been designed to find out if changes in mitochondria are related to postoperative complications. This will help doctors improve how they prepare patients for surgery and potentially how they manage their treatment, and result in improving outcomes for patients after surgery. This study will recruit patients scheduled for major abdominal surgery as part of their treatment. The investigators will take samples of breath, blood and muscle to measure changes in mitochondria from the day before surgery to 7 days postoperatively. The muscle samples will only be taken when the patient is asleep having their operation. These samples will be used to analyse mitochondria. This study will be in two phases. Phase 1 is a pilot of up to 10 patients focussed on feasibility. Following this there will be an interim data analysis. The results may allow further optimisation to reduce the patient burden, eg reduction in sampling frequency, or avoiding need for muscle biopsy. The second phase will be a full cohort study of up to 40 patients, focussed on association of mitochondrial markers with clinical outcomes, such as postoperative complications, oxygen levels, pain, confusion and length of intensive care stay. The results of this study could improve how doctors select and prepare patients for surgery. It may also affect how doctors manage their treatment during and after operations. This could result in reducing complications and illness burden for patients after surgery.

NCT ID: NCT05891535 Recruiting - Clinical trials for Perioperative Complication

Stentless Florence Robotic Intracorporeal Neobladder (FloRIN)

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Objective: To investigate perioperative and mid-term functional outcomes of stentless FloRIN reconfiguration as compared to standard technique performed with ureteral mono J placement. Patient and dataset Clinical and surgical data of all consecutive patients treated at our Institution from January 2021 to February 2022 with RARC, lymph node dissection (LND) and FloRIN reconfiguration were gathered in this single institution randomized 1:1 prospective series. All patients with clinical stage T1-T4N0-N1M0 amenable to radical cystectomy with curative intent and FloRIN reconfiguration were included. The sample size for a non-inferiority trial was calculated for different endpoints. Preoperative work-up included chest and abdomen contrast-enhanced computed tomography (CT) scan. Main exclusion criteria were: 1) presence of one or multiple tumor metastases at preoperative staging; 2) histopathological confirmation of bladder tumor at the level of prostatic urethra; 3) treatment without curative intent (cT4b, salvage or palliative cystectomies); 4) presence of urethral stricture. After preliminary multidisciplinary evaluation, patients were randomly assigned with 1:1 ratio to the mono-J stent placement or the stentless group. For the present study, only patients with a minimum 6 month-follow up were evaluated. Patient demographics, including ASA score and Charlson Comorbidity Index (CCI), peri- and postoperative features including operative time, conversion rate, estimated blood loss (EBL), Visual Analogue Scale (VAS) pain intensity scale, length of hospital stay (LOS) early (≤30 days) and delayed (>30 days) complications rate, and pathological data were thoroughly gathered. Follow-up schedule included blood analysis and CT scan performed three months after surgery, then every 6 months from the first to the third postoperative year, followed by annual imaging assessment according to individual risk profile, as postulated by the EAU guidelines. In case of newly diagnosed postoperative hydronephrosis, only patients with grade > 2 or symptomatic were assessed as functional failure. All eligible patients were offered the possibility to undergo neoadjuvant cisplatin-based chemotherapy before RARC. Patients with non-muscle invasive bladder cancer, cN+ disease and those presenting with severe cardiovascular morbidity or high preoperative creatinine levels, strongly contraindicating cisplatin administration, underwent immediate radical cystectomy. The enhanced recovery after surgery protocol (ERAS) was regularly applied. Suitable patients underwent a nutritional assessment with a specific immune-nutrition, 7 days preoperatively.

NCT ID: NCT05869578 Not yet recruiting - Clinical trials for Perioperative/Postoperative Complications

Registry of Anesthesia and Perioperative Medicine

RAMP
Start date: June 1, 2023
Phase:
Study type: Observational [Patient Registry]

To assess mortality and morbidity associated to anesthesia interventions

NCT ID: NCT05859620 Recruiting - Clinical trials for Myocardial Infarction

Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery

ImplementPMI
Start date: July 1, 2021
Phase:
Study type: Observational

The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients. Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.