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Complication, Postoperative clinical trials

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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.

NCT ID: NCT05271344 Recruiting - Pancreatic Cancer Clinical Trials

Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.

SIO3D
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

The purpose of this trial is to demonstrate that synbioimmunonutrition (SI) combined with omega-3 fatty acids (O3) and Vitamin D (D) is superior to conventional 7-day preoperative immunonutrition in terms of reducing overall morbidity, in cases of duodenopancreatectomy for tumoral lesion.

NCT ID: NCT05243771 Recruiting - Quality of Life Clinical Trials

Norwegian Stoma Trial

Start date: September 1, 2022
Phase:
Study type: Observational

The Norwegian Stoma Trial is an open-label multicenter trial investigating the use of stomas, both diveriting and permanent, in the surgical treatment of rectal cancer. The objective is to compare the chosen strategy to surgical complications, health realted quality of life and length of stay.

NCT ID: NCT05194943 Recruiting - Clinical trials for Bariatric Surgery Candidate

Trends and Safety in Revisional Bariatric Surgery in Italy

Start date: November 1, 2021
Phase:
Study type: Observational

Background: Revisional bariatric surgery (RBS) represents a further solution for patients who experience an inadequate response following initial bariatric surgery or significant weight regain following an initial satisfactory response. Studies including the follow-up of patients with complications after RBS are still lacking. Aim: to analyze the trend, mortality, and complications at 30 days after RBS in Italy. Secondary aim: 30-day readmission rate, reoperations for any reason related to bariatric surgery. Design: longitudinal, prospective, multicenter study. Time interval: 10 months October 2021 - July 2022). Setting: 11 high-volume bariatric centers of the Italian National Health Service (SSN), university hospitals, hospitals, accredited private centers. Methods: All patients undergoing RBS from 01.11.2021 through 31.04.2022 will be enrolled in a prospective, online database, registering indications, technique, mortality, intraoperative and perioperative complications, readmission for any reason. All participating centers follow the same preoperative work-up protocol, indications, informed consent, and postoperative follow-up, including scheduled telephone and outpatient visits after 7, 15 and 30 postoperative days. Inclusion criteria: revisional procedures; no concomitant procedure, but hiatal hernia repair; age >18<60 years; compensated comorbidities; informed consent including COVID-19 addendum; adherence to specific admission, in-hospital and follow-up protocols. Patients undergone RBS during 2016-2020 will be considered a control group. The study will not involve any modification of the usual protocols. Statistical analyze: to make qualitative quantitative comparison regarding clinical and anthropometric factors between the two study groups (2021-22; 2016-20), the z-test for two proportions and t-test (two-tailed) will be used, respectively. The significance is fixed at 0.05 and all analyzes will be performed with the SPSS v.27 software. Expected results: enroll about 500 patients to obtain information on the safety of RBS and the current trends in Italy.

NCT ID: NCT05188001 Active, not recruiting - Myocardial Injury Clinical Trials

Hemodynamics and Myocardial Injury After Non-cardiac Surgery

MINS
Start date: January 1, 2022
Phase:
Study type: Observational

The incidence of myocardial injury after non-cardiac surgery (MINS) is approximately 12-15% and is associated with an increased risk of 30-day mortality, 1-year mortality, and 2-year major vascular events. Using both traditional longitudinal analysis techniques and novel methods in machine learning, investigators will explore whether intraoperative and postoperative vital signs can enhance MINS surveillance by providing temporal prediction of MINS events.

NCT ID: NCT05159505 Recruiting - Scoliosis Clinical Trials

Interdisciplinary Scoliosis Correction Program.

Start date: December 1, 2021
Phase:
Study type: Observational

The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles.

NCT ID: NCT05144451 Recruiting - Clinical trials for Liver Transplantation

Transcranial Doppler During Liver Transplantation

Start date: November 28, 2021
Phase: N/A
Study type: Interventional

This is a prospective study that would investigate the transcranial doppler (TCD) changes during the living donor liver transplantation and the association between the TCD changes and the post-transplant neurological complications.

NCT ID: NCT05069402 Recruiting - Clinical trials for Complication,Postoperative

Impact of Various Diets on Surgical Complications

IMM4
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. Immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. This study was designed to assess the actual clinical significance of oral immunonutrition.

NCT ID: NCT04943419 Completed - Colorectal Cancer Clinical Trials

Myeloid-derived Suppressor Cells in Colorectal Cancer

Start date: April 1, 2016
Phase:
Study type: Observational

The aim of the study is to evaluate whether the preoperative level of myeloid-derived suppressor cells is associated with postoperative complications classified by Clavien-Dindo categories. Levels of all MDSC, polymorphonuclear MDSC (PMNMDSC), monocytic MDSC (MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMN MDCS) were established and compared in patients with postoperative complications, severe postoperative complications (>= IIIA according to Clavien-Dindo) and severe septic complications.

NCT ID: NCT04909567 Recruiting - ERAS Clinical Trials

Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery

OPT
Start date: October 26, 2021
Phase: N/A
Study type: Interventional

Colorectal cancer is one of the most common cancers globally. A majority are operated on for the purpose of cure. Complications after surgery are common, involve long length of stay and increase the risk of later recurrence of cancer. Optimization of physical and mental function before surgery can reduce the risk of complications and provide a faster recovery. However, a standardized form for how optimization should be performed does not exist. At Danderyd Hospital, Stockholm, Sweden, we are starting up an optimization center where patients are offered optimizing measures while waiting for surgery. This form of structured treatment has not been studied before and we therefore want to investigate outcomes in a randomized study. All patients with colorectal cancer who are being examined for surgery are offered participation in the study. Randomization of 518 patients in to either an intervention group where the patients; are optimized for concomitant diseases, treated for malnutrition and overconsumption of alcohol and tobacco, undergoes an exercise program and receives psychosocial support before surgery, or a control group where patients are prepared for surgery according to current routines. Primary outcome is the difference in severe complications between the groups. Secondary outcome is difference in length of stay as well as fitness and mental well-being before and 30 days after the operation.If optimization before surgery reduces complications and shortens length of stay, the model can also be used by other operating specialties. This may result in a great improvement for the healthcare in general.