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Postoperative Complications clinical trials

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NCT ID: NCT05491434 Recruiting - Sarcopenia Clinical Trials

Sarcopenia in Colorectal Cancer Patients, Intervention Study

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The sarcopenia is a new concept for evaluating the functional status of patients, introduced during the last 20 years. This is defined as the relationship between the deterioration of muscle mass and the decrease in strength, the metabolic rate, the aerobic capacity and subsequently the evaluation of the functional status. The sarcopenia has been estimated to affect 5% to 13% of people aged between 60 and 70 years, increasing from 11% to 50% in those aged 80 years and older. In a study by Lieffers et al. of a total of 234 patients with colorectal cancer, with a mean age of 63 years according to the values observed by Prado et al., the prevalence of sarcopenia would be around 39%, being able to reach up to 60% in patients with chronic diseases. The goal of this study is to compare the cumulative incidence of post-surgical complications due to infection at 30 days between the group of patients without sarcopenia and the group of patients with sarcopenia with an intervention based on a nutritional supplement + physical exercise.

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: NCT05487638 Completed - Clinical trials for Postoperative Complications

The Effect of Telephone Nursing Education and Counseling Services Given to Satisfaction Level and Self-Care Strength

Start date: June 3, 2022
Phase: N/A
Study type: Interventional

In the post-discharge period, it is important to follow the patients from home by telephone and to provide the necessary nursing education and counseling services, increasing the self-care powers of the patients, increasing their quality of life, adapting to the social life after discharge and facilitating the patient's adaptation to the post-discharge process. When the literature is examined, it can be said that the study is original since there are no studies on this subject. The aim of this study is to determine the effect of nursing education and counseling service given to patients who have undergone CABG, on the level of discharge satisfaction and self-care power of patients.

NCT ID: NCT05485857 Completed - Clinical trials for Postoperative Complications

Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery

Start date: November 29, 2022
Phase: N/A
Study type: Interventional

The method of arranging and restoring the position of the small intestine under laparoscopy is used to determine whether it can promote the recovery of intestinal function after colorectal surgery.

NCT ID: NCT05483179 Completed - Colorectal Cancer Clinical Trials

Association Between New Effort-independent Cardiopulmonary Exercise Test Variables and Postoperative Complications After Elective Colorectal Surgery

Start date: April 15, 2022
Phase:
Study type: Observational

A cardiopulmonary exercise test (CPET) is increasingly used for preoperative risk assessment. Oxygen uptake (VO2) at peak exercise (VO2peak) and VO2 at the ventilatory anaerobic threshold (VO2VAT) are the most commonly used preoperative CPET variables that are associated with postoperative outcomes following colorectal cancer surgery. The aim of this study is to investigate the association between two relatively new preoperative submaximal and effort-independent CPET variables, the cardiopulmonary optimal point (COP) and the Oxyen uptake efficiency plateau (OUEP) and postoperative outcomes in colorectal cancer surgery. In additiion, the association between the oxygen uptake at the COP en OUEP and postoperative outcomes wil be explored.

NCT ID: NCT05479825 Recruiting - Clinical trials for Postoperative Complications

Tubeless Intersegmentectomy Plane Identification With Fluorography

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic). Methods: A one- armed, prospective randomized controlled study was designed. The intersegmental plane was not so clear during the tubeless minimally invasive segmentectomy, and the presentation of the plane sometimes cost more time. This study will evaluate consecutive patients with the combination of inflation- deflation method and fluorography with the ICG injection.

NCT ID: NCT05474677 Enrolling by invitation - Clinical trials for Suture Size, Incisional Hernia

The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Background: Incisional hernia is a common complication of midline laparotomy, and it is associated with high morbidity and high costs. Suture size used in the closure of the abdominal wall fascia was not studied independently. Objective: Identify the best suture size for closure of the fascia following laparotomy incisions, by assessing the suture size 2\0 versus zero. Research methods: Prospective, multicentric, randomized controlled and double-blind trial. Patients undergoing elective or emergency laparotomy in Royal Hospital, Sultan Qaboos University Hospital and Armed Force Hospital between 2022 and 2023. We aimed for a total of 276 patients (n=138 per group). The abdomen will be closed in intervention group with continuous PDS 2\0 sutures and size zero in control group. Patients will be followed for immediate post-operative wound complications and late complication after 6 months then after one year.

NCT ID: NCT05471882 Not yet recruiting - Clinical trials for Postoperative Complications

Predicting Neuromuscular Recovery in Surgical Patients Using Machine Learning

PINES
Start date: November 1, 2022
Phase:
Study type: Observational

Despite emerging efforts to decrease residual paralysis and postoperative complications with the use of quantitative neuromuscular monitoring and reversal agents their incidences remain high. In an optimal setting, neuromuscular blocking agents are dosed in a way that there is no residual block at the end of surgery. The effect of neuromuscular blocking agents, however, is highly variable and is not only influenced by their dose, but also by several patient-related factors such as muscle status, metabolic activity, and anesthesia management. Accordingly, the duration of action is difficult to predict. The PINES project will use artificial intelligence methods to develop a model that can accurately predict the course of action of neuromuscular blocking agents. It will be used to predict time to complete neuromuscular recovery (train-of-four [TOF] ratio >0.95) and may provide as a decision support in the individual management of timing and dosing of neuromuscular blocking drugs and their reversal agents.

NCT ID: NCT05459038 Not yet recruiting - Surgery Clinical Trials

Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.

Start date: September 2022
Phase: N/A
Study type: Interventional

Tibia shaft fractures are common long bone fractures in the field of Orthopaedic Trauma. In the USA, a total of 492.000 tibial fractures were reported per year by the National Center of Health Statistics (NCHS). Intramedullary nailing (IMN) is the treatment of choice for shaft fractures. However, rotational malalignment (RM) remains an iatrogenic pitfall with a prevalence up to 30%. From a clinical point of view, there is limited knowledge on how to avoid RM during IMN. Clinical estimation of tibial alignment is difficult, resulting frequently in RM following IMN. Low-dose CT-assessment is considered the gold standard to objectify RM, but is performed after surgery when the opportunity for direct revision has passed. Both difficulties in intraoperative clinical judgement of tibial alignment as well as postoperative detection of RM when the possibility for direct revision has passed, do support the need for an easy-to-use intraoperative fluoroscopy protocol to minimize the risk for RM during IMN of tibial shaft fractures. Recently, a standardized intraoperative fluoroscopy protocol named the 'C-Arm Rotational View (CARV)' was determined in order to improve the accuracy of alignment control during IMN of tibial shaft fractures. CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used. Promising preliminary results were found to reduce the risk on RM following IMN of tibia fractures. However, a prospective trial is needed to determine the performance of CARV in clinical practice. Therefore, a prospective multi-center randomized controlled trial is designed to assess the clinical feasibility and potential benefits of the CARV-protocol. The following primary research question was defined: can the risk for RM following IMN of tibial shaft fractures be minimized by use of the CARV-protocol?

NCT ID: NCT05455801 Completed - Clinical trials for Surgical Site Infection

Study to Analyze the Surgical Site Infections in a Group of Patients Who Were Randomly Applied a Negative Pressure Therapy Dressing Versus Conventional Dressing

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Surgical site complications generate a series of consequences that prolong hospital stay, increase interventions and procedures, and consequently considerably increase healthcare costs. Hence, the importance of studying measures to reduce these complications and the most feared of them is surgical site infection. The objective of the study is to analyze the complications of the surgical site in a group of participante with risk factors for developing them after undergone abdominal surgery in the period described.