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Complication, Postoperative clinical trials

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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: NCT06088823 Recruiting - Clinical trials for Complication,Postoperative

Paresthesia in Hand and Antebrachium Following CardiacSurgery: Incidence, Risk Factors and Clinical Course

Start date: October 6, 2023
Phase:
Study type: Observational

To describe the incidence and severity of Paresthesia in Hand and Antebrachium in patients that have undergone CardiacSurgery.

NCT ID: NCT06080893 Recruiting - Anemia Clinical Trials

The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures

Start date: October 10, 2023
Phase:
Study type: Observational [Patient Registry]

Hip fractures (HF) are the most common and serious pathology affecting the hip and are associated with a high mortality risk in elderly patients. The prevalence of HF is increasing day by day and surgery is often required for its treatment. Perioperative anemia not only hinders the early recovery and rapid rehabilitation of elderly patients, but also adversely increases the need for blood transfusion, prolongs hospital length of stay (HLS) and even increases the risk of death. Although the blood transfusion threshold is restrictive, approximately one or two thirds of elderly patients with hip fracture surgery (HFS) require blood transfusion during hospitalization, and blood transfusion also has potential side effects.The most important factor in the development of anemia in HF is blood loss; however, there are other mechanisms (renal failure, inflammation, iatrogenic hemodilution) that lead to the selection of different therapeutic approaches.Oral or intravenous iron supplementation is a well-accepted alternative to counteract or prevent perioperative anemia, stimulate erythropoiesis and increase Hgb level in elderly patients. However, there are few studies addressing the relationship between iron therapy and clinical outcomes or mortality. Because ferric carboxymaltose (FCM) allows doses of 2 g in a single session (and can be administered by a short IV infusion of 15-20 minutes), and furthermore, FCM is excellently tolerated and safe for patients. This study was planned to investigate the relationship between FCM supplementation and blood transfusion volume, HLS, postoperative infection and mortality.

NCT ID: NCT06014619 Recruiting - Skin Cancer Clinical Trials

Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

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

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

NCT ID: NCT05995925 Recruiting - Clinical trials for Complication,Postoperative

Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)

OPICU
Start date: January 3, 2024
Phase:
Study type: Observational

This clinical trial will be carried out as a national multicenter observational cohort trial in Turkey. Our starting point is the need to triage postoperative patients daily due to the limited intensive care unit (ICU) bed capacity. Our hypothesis is that patients requiring emergency or unplanned ICU admission generally meet the ICU admission criteria. However, postoperative patients admitted to the ICU for planned reasons often do not meet the ICU admission criteria and can be monitored in a lower-level unit (Postoperative Care Unit - PACU) for close observation purposes. The primary aim is to assess the efficient utilization of ICU beds. We try to compare the treatments provided during ICU follow-up, for planned and unplanned patients requiring ICU admission. Our secondary outcome is to identify criteria that can predict ICU indications based on patients' preoperative characteristics and evaluate the postoperative complications according to the Clavien-Dindo classification. Our aim is to categorize patients admitted to the ICU into two groups: planned and unplanned/emergency cases and compare the necessity of ICU care between these two groups. The need for ICU treatment will be determined based on the criteria established in the following* study. The presence of any of these criteria will indicate the need for ICU admission, while the absence of these criteria may identify patients admitted to the ICU only for monitoring purposes (i.e., unnecessary ICU admissions).

NCT ID: NCT05637606 Recruiting - Blood Pressure Clinical Trials

HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery

HISTAP
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.

NCT ID: NCT05593783 Recruiting - Clinical trials for Complication,Postoperative

The Use of the "Comprehensive Complication Index" for Urinary Lithiasis Surgery.

Start date: October 21, 2022
Phase:
Study type: Observational

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Data regarding post operative descriptions will be recorded and comprehensive complication index will be used for the assesment of the burden.

NCT ID: NCT05575089 Recruiting - Clinical trials for Bariatric Surgery Candidate

Inspiratory Muscle Training and Pulmonary Function in Patients Submitted to Bariatric Surgery

Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Obesity is defined as a body mass index greater than or equal to 30 kg / m2 and represents a public health problem that affects the world population. It is associated with a higher frequency of cardiovascular, metabolic diseases, and respiratory morbidities, which affect the quality of life of patients. Its treatment comprises different strategies, however, due the conventional treatments, surgical treatment has been the most sought after today. Objectives: To evaluate the effectiveness of preoperative inspiratory muscle training in the evolution of respiratory muscle strength in patients undergoing bariatric surgery. Methodology: Randomized clinical trial. All patients will be assessed in the pre operative period and randomized into 2 groups: control group and intervention group. The main variables are maximum inspiratory and expiratory muscle strength (MIP and MEP), peak cough flow (PCF) and pain. Control group will perform proposed respiratory physiotherapy, aerobic exercises and use of incentive inspirometry, the intervention group will perform proposed physiotherapy, aerobic exercises and use of Powerbreathe for inspiratory muscle training. Both groups will perform 10 non consecutive face-to-face physiotherapy sessions ( up 30 days before surgery). After the surgical intervention, they will be evaluated on the first and 30th postoperative days in relation to the same variables and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. After the intervention, they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. After the intervention, they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. Categorical variables will be summarized in absolute and relative frequencies (percentages). Information regarding numerical variables will be expressed as means, standard deviations or medians, and interquartile range, depending on the distribution of the variable. All variables will be tested in relation to their distribution. To analyze the results between groups will be used the mixed linear models and for intragroup analysis, two-way ANOVA (time and group) for the following variables: MIP and MEP, PCF and pain. Expected results: Preoperative inspiratory muscle training can maintain/improve respiratory muscle strength until the moment prior to surgery, thus better preparing the patient for the condition of surgical stress, in addition to decreasing the incidence of pulmonary complications during the hospitalization period and / or in the 30 postoperative days.

NCT ID: NCT05489757 Recruiting - Clinical trials for Complication of Surgical Procedure

Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery

SPY Q-ICG PAS
Start date: February 16, 2022
Phase: N/A
Study type: Interventional

The accurate assessment of intraoperative tissue perfusion is essential in any branch of surgery. Anastomotic leakage (AL) is one of the most feared complications following gastrointestinal surgery, with potentially threatening consequences resulting in worsened short- and long-term outcomes. Consistently, a recent meta-analysis showed a correlation between AL and shorter disease-free survival in colorectal surgery. Despite its multifactorial origin, AL is highly related to inadequate visceral perfusion. Traditionally, perfusion assessment and subsequent anastomotic viability have been evaluated by surgeons using intraoperative indicators, such as color, pulsation of vessels, presence of peristalsis and bleeding from the resection lines. However, these clinical parameters are not able to reliably assess the real visceral perfusion and their evaluation is limited in minimally invasive surgery. Hence, the growing interest for innovative techniques able to properly assess tissue perfusion. Among these, the fluorescence angiography (FA) with indocyanine green (ICG) has become increasingly popular during the last decade, although its approval for biomedical purposes by the Food and Drug Administration (FDA) dates back to 1956. ICG is an amphiphilic, non-toxic, tricarbocyanine iodide dye that can be safely injected intravenously and is exclusively eliminated by the liver, without any absorption. Thanks to its fluorescent properties, it allows the real-time visualization of tissue vascularization. FA with ICG has shown promising results for the evaluation of perfusion in numerous surgical procedures, thus leading to modifications of the surgical strategy and consequently to a decrease in the rates of AL. On the other hand, ICG interpretation is subjective, based on the evaluation of fluorescence performed by the operating surgeon. These results lack into a high inter-observer variability and affect the possibility to obtain objective, reproducible and reliable tissue perfusion assessments. Quantitative fluorescence angiography with ICG (Q-ICG) could overcome these limitations. In Q-ICG the fluorescence signal is elaborated by a new computer quantification algorithm and translated into a fluorescence-time curve (FTC), from which several Q-ICG parameters and values can be extracted. Given the power of ICG in reflecting the perfusion of examined tissues, a new quantification algorithm has the potential to turn the subjective parameters derived from surgeon's perspective into objective numeric values. The primary aim of this study is to evaluate which Q-ICG values provided by a new quantification algorithm correspond to subjective perfusion parameters usually evaluated by the surgeon in patients undergoing left colon, rectal or esophagogastric resections. The secondary aim is to evaluate possible correlations between Q-ICG values provided by the quantification algorithm and perioperative outcomes.

NCT ID: NCT05277441 Recruiting - Clinical trials for Complication of Surgical Procedure

A Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification

ComPedS
Start date: January 1, 2017
Phase:
Study type: Observational

Postoperative adverse events may be associated with substantial morbidity and mortality. However, inconsistent definitions of complications and unexpected events have limited accurate analysis of surgical outcomes. In 2004, the Clavien-Dindo classification for postoperative complications has been introduced and has since then been validated in numerous studies, with more than 20.000 citations. Despite the appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of grading systems for adults into a pediatric cohort without modification or validation. In a recent study we have shown that few items of the classification do not offer relevant information in pediatric cohorts and we have added organizational and management errors, not integrated in the initial proposal by Dindo et al. Especially, the variety of options for the management of complications based on institutional protocols and logistics is emphasized and a more focused and detailed assessment of the invasiveness of procedures in children is introduced.