300,000+ clinical trials. Find the right one.

72 active trials for Surgery- Complications

Non-invasive Methods and Surgical Risk Stratification in Cirrhotics Undergoing Elective Extrahepatic Surgery

The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

Start: August 2020

Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

Start: August 2019

Incidence of Post-operative Atrial Fibrillation Secondary to Abdominal Surgery

Background and purpose Post-operative AF (POAF) is considered a phenomenon rather than a definite diagnosis and the current clinical guidelines have no specific recommendations regarding its management. Few prospective studies have been performed in non-cardiac conditions and consequences of POAF in patients without known heart disease is not well described. However, recent data suggest an association between POAF in relation to non-cardiac surgery and increased post-operative mortality and stroke. POAF in relation to abdominal surgery seems common (incidence: 8-18%); however, the true incidence is uncertain. The available studies are few, heterogenous and often methodologically inadequate. The study aims at reporting the true incidence of AF, and associated complications, in relation to abdominal surgery. Material and methods Designed as a prospective, single-centre, cohort study of consecutive adult patients undergoing acute or elective abdominal surgery at Department of Abdominal Surgery at Bispebjerg Hospital. Patients who are pregnant or where follow-up is not possible will be excluded. Patients will be examined pre-operatively by ECG and signal processed surface ECG (wavECG). Heart rhythm monitoring will be worn from admission and until discharge (preferably ?72 hour post-operatively). Examinations are repeated 90 days post-operatively. Additional follow-up will be based on patient charts for ?12 months. Primary endpoint is occurrence/recurrence of AF. The study will include 300 patients. Perspective If more thorough heart rhythm monitoring of patients undergoing abdominal surgery leads to identification of more patients with AF, routine continuous heart rhythm monitoring should be considered recommended in upcoming guidelines to prevent associated complications.

Start: June 2020

ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy

In the study, the enhanced recovery after surgery (ERAS) program is applied to total pancreatectomy (TP) and low-risk pancreaticoduodenectomy (PD) patients identified by a small number of acinar cells in the cut edge of the pancreas. The research setting is randomized and controlled. All patients arriving at the Tampere University Hospital (TAUH) for PD or TP surgery are recruited into the study. Recruited patients are randomized to the ERAS protocol and to the standard protocol recovery program. The ERAS program differs from the normal care protocol preoperatively, intraoperatively and postoperatively as explained in the following section. In the ERAS protocol, both on the previous day of the surgery and on the following days, the patient is discussed with the patient about the benefits of the protocol used and the recovery program objectives. The purpose is to motivate and encourage the patient. On the day of surgery, the patient's intake of food and fluids is allowed to be closer to the surgery and the patient is also given a carbohydrate drink two hours before surgery. The nasogastric tube set at the beginning of surgery is removed at the end of the surgery and peripancreatic or perihepatic drains are not routinely placed. After surgery, drinking is allowed after four hours and the patient is encouraged to move as actively as possible in the bed. On the first and second postoperative day, the patient is allowed to enjoy normal food and drink according to his or her ability, and pancreatic capsules are given in the course of food. Additionally, the analgesic to be administered through the epidural cannula is dosed as far as possible to allow mobilization of the patient. The discussion on the benefits and recovery targets of the ERAS protocol are continued. On the third postoperative day, the epidural infusion is discontinued and the pain medication is moved to opioid-based pain management. This is continued until specific criteria for passing to the follow-up care are met. Typical complications (pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage) are registered during hospitalization and their severity ratings according to ISGPS, ISPGF and Clavien-Dindo classifications are also determined. Other variables registered are the number of intensive care days, situations requiring new surgeries, 30 and 90 day mortality, the completion time of the criteria for passing to follow up care, and the total length of hospitalization. In addition, the need for readmissions is registered. The implementation of the ERAS protocol is followed by a separate tracking template, in which the nurses record the progress of the goals specified in the protocol on a daily basis. The results of the study are analyzed with the intention-to-treat principle.

Start: September 2020

Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery

The purpose of this small randomized pilot study is to evaluate adherence to strict transfusion protocols in both the control and ANH group examining compliant and noncompliant transfusion rates and reasons for violation of the protocol if present. Data on transfusion requirements for both groups (with and without ANH) will be evaluated to determine sample size and feasibility of performing a larger study on ANH in our patient population. The ultimate purpose of a larger study would be to determine if acute normovolemic hemodilution results in a reduction in red blood cell units transfused in patients undergoing cardiac surgery involving cardiopulmonary bypass (CPB) and to carefully determine provider adherence to specific transfusion triggers for the administration of each unit of harvested and banked blood transfused. Secondary endpoints that will be evaluated in a larger study include any difference in the number of other blood products transfused including fresh frozen plasma, platelets, and cryoprecipitate as well as differences in coagulation status as measured by thromboelastography (TEG), INR/PTT, platelet count, and fibrinogen level, and ICU/hospital length of stay.

Start: November 2017

Celecoxib vs. Acetaminophen/Codeine/Caffeine for Post-operative Analgesia in Rhinoplasty.

The primary aim of this study is to evaluate whether celecoxib (CELEBREX) is equivalent to acetaminophen-codeine-caffeine (TYLENOL# 3) for the management of pain after primary elective open septorhinoplasty with osteotomies. Secondary objectives include comparison of adverse medication effects and complications (e.g., bleeding events and bruising) that occur postoperatively. Half of the study participants will receive celecoxib, and half will receive acetaminophen-codeine-caffeine. We hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding, but that participants taking CELEBREX will experience less medication-related side effects and less bruising postoperatively.

Start: March 2020

Variability of Heart Rate as a Marker of Complication of Colorectal Surgery

Heart rate variability reflects the autonomic nervous system on the intrinsic activity of sinus node cells. Sympathetic hyperactivity is an adaptation to stress, while parasympathetic hyperactivity is present at rest. Thus, any variability in the heart frequency rate reflects variations in sympathetic and parasympathetic components in the autonomic nervous system. Failure to return to normal or a reduction in the variability of the heart rate in the postoperative period is correlated with complications in colorectal surgery.

Start: June 2020

Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap

Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap

Start: July 2019

3D-HD Optic Systems Influence Surgical Performance

Randomized controlled trial in which two different laparoscopic systems: standard 2D and Olympus VISERA Elite II 3D will be compared in terms of laparoscopic skills, length of surgery, intraoperative complications and surgeon's fatigue in a group of senior surgeons and senior residents will be measured when performing laparoscopic Roux-en-Y gastric bypass.

Start: February 2020

The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients

The goal of this study is to perform a randomized clinical trial to assess the effects of vitamin C versus placebo on wound healing in mandibular fracture patients.

Start: October 2017

A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery

The purpose of this study is to develop an all-encompassing frailty model using laboratory and functional studies. A frailty model will help us determine prior to surgery who will require rehabilitation and skilled nursing needs beyond discharge. This model will also help us determine who will likely be readmitted and why they will be readmitted. Understanding these things can help us prevent some of them from occurring in the future.

Start: January 2018

The Utility of Enhanced Pre and Post-surgical Work-out to Prevent the Spread of COVID-19 in a Large Urology Department

Since the outbreak of COVID-19 hit Spain in March 2020, most of the elective surgeries have been canceled everywhere. As soon as the epidemiology phase of the pandemic changed and the restrictions have been eased, different protocols have been put in place to screen patients for SARS-CoV-2 before surgery in order to reduce the spreading of the disease in hospitalized patients. To the best of the current state of knowledge, no recommendations or protocols have been established to guide surgeons in dealing with patients developing unspecific symptoms after surgeries, which could sign either of a post-op complication or COVID-19. The investigators have developed an enhanced pre and post-surgical protocol both to screen patients for COVID-19 before surgery and to promptly identify those patients suspicious for the viral infection during the post-op.

Start: March 2020

Prophylaxis of Surgical Wound Infection With Topical Antibiotics

Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.

Start: December 2018

Use of Wearables for Early Detection of Complications After Major Acute Abdominal Surgery

The purpose of the study is to investigate whether glucose profile, sleep disturbances and heart rate variability measured with wearable devices is associated with postoperative recovery and complications within 30 days after major emergency abdominal surgery. The study is designed as an explorative, prospective cohort study. 40 patients undergoing major emergency abdominal surgery at Zealand's University Hospital Køge are included in the study, and inclusion occurs within 24 hours of end of surgery. Patients will be followed for 30 days, and three scheduled study visits are planned during follow up at postoperative day 10, 20 and 30. Glucose is measured continuously with a wearable subcutaneous sensor (Dexcom G6). Glucose readings are validated in the perioperative setting using blood glucose measurements obtained with standard finger-pricks 3-5 times a day during hospitalization. Actigraphy is used for assessing sleep- and activity patterns for the full study period. Heart rate variation is measured with a compact Holter monitor. Furthermore, the study assesses patient-reported quality of recovery, glucose metabolism, nutritional status and mobility. Various data on demographics, peri- and postoperative data will be extracted from the electronic patient chart.

Start: October 2019

Carbohydrate Loading and Diabetes in Colorectal Surgery

The goal of this study is to evaluate the feasibility of conducting a large study that would assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2 diabetes. Traditionally, prior to surgeries involving a general anesthetic, patients have been told not to eat or drink anything after midnight due to the risk of aspiration. More recent research have shown that it is safe to have clear fluids up to 2 hours before an operation and this is reflected in the current anesthesia clinical guidelines. Moreover, it has been shown that subjecting patients to a state of starvation causes stress on the body that may lead to complications such as poor wound healing, infections, and delayed return to bowel function. A sugar drink before surgery has been shown to be beneficial and can lead to decreased complication rates and decreased length of stay after surgery. However, it is currently not known if it is safe for patients with type 2 diabetes to have a sugar drink before their surgery since they have trouble processing sugars and a subset of patients with diabetes are at increased risk of aspiration due to delayed stomach emptying. This feasibility study is designed to answer the question of whether a large scale trial can be conducted examining the benefits of a pre-operative sugar drink in patients with type 2 diabetes.

Start: March 2018

Does Prehabilitation Improve Outcome in Coloncancer Surgery?

The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.

Start: October 2020

Perioperative Management Evaluation in Patients With CIED

Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives. Objective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine. Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics Primary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery/intervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming / device revision). Inclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age >18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available Patient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing > 700 interventions are expected.

Start: November 2018

Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

In the ProPEL study the effect of a protocol designed for elderly patients about to undergo emergency abdominal surgery will be investigated. The protocol addresses issues of both frailty and ceiling-of -care decisions.

Start: January 2020

The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty

This study evaluates whether participating in a home-based exercise program leads to lower levels of complication rates and patient-reported disability after surgery. Half of the participants will be randomized into the exercise group, while the other half will be randomized into the control group.

Start: February 2020

Preoperative Oral Nutritional Supplement vs Conventional Dietary Advice in Major Gastrointestinal Surgery

Surgical outcome is associated the nutritional status of the patients. Perioperative nutritional supplement for malnutritional patient were recommended. There are several guidelines were recommended the perioperative nutrition for malnutrition patients. But in our hospital, there are no consensus guideline applied for the clinical practice. The nutritional supplement was judged by only attending physical This study was conducted to comparing the perioperative nutritional supplement with oral supplement with conventional approach with only dietary advice alone for all patients who undergoing major gastrointestinal surgery.

Start: November 2017