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Surgery--Complications clinical trials

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NCT ID: NCT04162860 Recruiting - Esophageal Cancer Clinical Trials

Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

Start date: December 4, 2019
Phase: N/A
Study type: Interventional

The primary objective of the preSponge randomized controlled trial (RCT) will be to assess the potential protective effects of preemptive endoscopic negative pressure therapy (ENP) on postoperative morbidity in high-risk patients undergoing total minimally invasive transthoracic esophagectomy with gastric pull-up reconstruction and high intrathoracic anastomosis (thoracoscopic and laparoscopic Ivor Lewis esophagectomy).

NCT ID: NCT04161599 Recruiting - Wounds and Injuries Clinical Trials

Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.

ORALEV2
Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.

NCT ID: NCT04124757 Recruiting - Clinical trials for Neuromuscular Blockade

Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety

EURORELAX
Start date: February 11, 2020
Phase: N/A
Study type: Interventional

Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular block (NMB) improves the surgical working conditions over a moderate NMB and effectively precludes sudden deterioration of the surgical field. However, whether the improvement of surgical working conditions translates into less intra- and postoperative complications remains uncertain. Small prospective or retrospective studies shown an decrease of the incidence of intraoperative adverse events and postoperative complications after a deep NMB. There is a need to confirm these outcome data prospectively, in a large number of patients and clinics and during a variety of surgical procedures.

NCT ID: NCT04059731 Recruiting - Colorectal Cancer Clinical Trials

Postoperative Diet With Hyperproteic Supplement Versus a Supplement With Imunonutrients, in Colorectal Cancer Surgery

NUTRICOLON
Start date: June 20, 2019
Phase: N/A
Study type: Interventional

The study is a randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate the non-inferiority in efficacy and therapeutic safety of the postoperative diet with oligomeric-hyperprotéic-normocaloric supplement (group 1) versus a supplement with imunonutrients (group 2), in a multimodal rehabilitation regimen (ERAS) of colorectal surgery for colon cancer and that arrive at surgery in a normal nutritional state or without any intervention on their nutritional status, according to the scale Malnutrition Screening Tool (MST).

NCT ID: NCT04027088 Recruiting - Gastric Cancer Clinical Trials

Effect of Preoperative Immunonutrition in Upper Digestive Tract

Start date: August 10, 2019
Phase: N/A
Study type: Interventional

Randomized, double-blind, multicenter clinical trial that will evaluate the effects of immuno-nutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach, and pancreas). The aim is to compare the specific effect of the immunonutrients respect to an equivalent formula in caloric-protein value but without immunonutrients, in the surgical evolution of the cancer patient.

NCT ID: NCT04021186 Recruiting - Clinical trials for Surgery--Complications

An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.

Start date: July 5, 2019
Phase: N/A
Study type: Interventional

Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Furthermore it is examined whether this optimization in treatment can result in reduced hospitalization time and fewer re-admissions. Hypothesis: Continuous blood glucose measurement and insulin therapy will optimize the postoperative phase of the embedded head and neck patient receiving Dexamethasone by reducing the incidence of hyperglycaemia and associated complications.

NCT ID: NCT03981835 Recruiting - Surgery Clinical Trials

Management of Antiplatelet Regimen During Surgical Procedures

MARS
Start date: August 1, 2019
Phase:
Study type: Observational [Patient Registry]

There are key differences today in clinical practice regarding perioperative management of post-PCI patients on DAPT undergoing NCS. Moreover, there are significant differences between bridging agents, and improved safety of current-generation DES. Given the significant limitations of current studies a well-designed registry to study current U.S. practice patterns and the bleeding or ischemic risks associated with the various perioperative DAPT management strategies including bridging and no bridging will significantly add to the understanding of the current problem and associated risks of patients. These data could form the basis for conducting future randomized clinical trials (RCTs) in this area. NCS in post-PCI patients on chronic DAPT presents a complex interaction of both ischemic and bleeding risks. The MARS registry will study the area of perioperative antiplatelet therapy management through a multicenter observational national registry designed to collect pre-operative, intra-operative and post-operative clinical strategies, therapeutic interventions and outcomes data. This proposal outlines the role of a highly experienced clinical trial team to conduct a multicenter prospective registry. This question is highly relevant to a diverse group of medical providers and millions of patients in the US and around the world; this will be the first such U.S. registry to address this critically important public health issue. Study objectives: i. To collect data on contemporary clinical practice in the U.S. on managing post percutaneous coronary intervention (PCI) DAPT in patients scheduled to undergo NCS and CS. ii. To assess ischemic and bleeding endpoints in this group of patients during the study period. iii. To generate initial data to plan for future large-scale randomized clinical trials on perioperative management of DAPT.

NCT ID: NCT03978325 Recruiting - Physical Activity Clinical Trials

Preoperative Exercise for Patients Undergoing Complex Cancer Surgery

PRE-HIIT
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Treatment for people with cancer of the lung or the oesophagus (food-pipe) often involves surgery. This surgery is complex and there is a high risk that patients will develop severe complications afterwards, leading to a longer hospital stay and higher hospital costs, and impacting greatly on recovery and quality of life. If patients' lungs and heart can be optimised before surgery, then recovery may be improved. While fitness can be improved by exercise, the lead-in time to surgery following a cancer diagnosis is often very short, and research is needed to examine what types of exercise might be most effective at increasing fitness over a short period. This project will investigate if high intensity interval training (HIIT) can increase fitness levels in people scheduled for surgery for cancer of the oesophagus or the lungs. HIIT alternates between periods of high intensity exercise, cycling on a stationary bike, followed by a period of more relaxed exercise. This approach is known to improve fitness but has not previously been investigated in patients awaiting complex cancer surgery. Groups will be compared for changes in pre-surgery fitness levels, any complications they may experience after surgery, general physical recovery after surgery and the cost of care after surgery. The investigators anticipate that patients who undergo HIIT before surgery will have less complications and better recovery after surgery, a significantly improved quality of life, and lower costs of care.

NCT ID: NCT03959904 Recruiting - Clinical trials for Surgery--Complications

The Impact of Abdominal Wall Closure Technique on Incidence of Incisional Hernia in Kidney Transplantation

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

STUDY SUMMARY Incisional hernias, or swellings of the abdominal scar after surgery, remain problematic especially after transplant surgery. This is because they can cause complications, including trapping of bowel or the transplant. This can cause life threatening emergencies but is at the very least unsightly and uncomfortable for the patient. Transplant patients are especially likely to develop hernias because of the diseases causing the renal failure and the drugs that they take to dampen the immune system. There is evidence from other surgery that the stitching methods that are used to close the wounds might decrease the risk of surgical hernias. This is achieved by placing smaller and more numerous sutures (stitches) in the wound to increase the strength of the repair. However, this has never been tested formally in transplant where it may provide significant benefit. We intend to do some initial investigation of whether using the smaller stitches may provide benefit over more traditional methods that are currently being used. We will look at early complications after surgery but also the rate of hernia formation later. We hope to improve outcomes and reduce complications for our transplant patients by doing this. In addition we will collect blood and tissue samples from both live kidney donors and the recipients to microscopically analyse their collagen to identify potential factors which may indicate risk of hernia formation.

NCT ID: NCT03838575 Recruiting - Surgery Clinical Trials

ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions

ROSSINI 2
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

ROSSINI 2 is a phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor), multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of several in-theatre interventions, used alone or in combination, to reduce SSI rates in patients undergoing surgery.