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Complication clinical trials

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NCT ID: NCT03228108 Completed - Prostate Cancer Clinical Trials

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

pro-SWAP
Start date: April 3, 2018
Phase: Phase 4
Study type: Interventional

This study aims to assess the effectiveness and cost-effectiveness of rectal swab culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral ciprofloxacin (control group), while the other half will receive rectal culture-guided oral antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis, comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative oral antibiotic based on the culture results will be prescribed (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin). The investigators hypothesise that the targeted prophylaxis group (intervention group) will have a lower rate of post-biopsy infectious complications compared to the control group.

NCT ID: NCT03174509 Recruiting - Complication Clinical Trials

Is Positive Pressure Extubation a Safe Procedure?

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and without positive pressure in the airways).

NCT ID: NCT03147586 Active, not recruiting - Bladder Cancer Clinical Trials

Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

This is a randomised double-blinded placebo-controlled phase IV trial with two parallel treatment groups receiving either immune nutrition diet (IND) or conventional diet for 2weeks peri-radical cystectomy. Patients will be stratified according to the gender, body mass index, and the type of urinary diversion (orthotopic neobladder or ileal conduit). The primary end-point is to determine, in intention to treat analysis, the influence of IND on 90-day postoperative morbidity. Secondary study end-points will be the effect of IND on infectious as well as non-infectious complications over 90 days, compliance and adverse effects of IND. Finally, an ancillary study will be performed to evaluate whether the IND costs could counterbalance, by its benefits, the health care costs.It is envisaged to finish patients' recruitment within 24 months

NCT ID: NCT03113513 Active, not recruiting - Quality of Life Clinical Trials

Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse

Start date: May 1, 2016
Phase: N/A
Study type: Interventional

To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

NCT ID: NCT03105713 Recruiting - Surgery Clinical Trials

Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery

PASC
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Building on the Norwegian Patient Safety Program's target areas, the Patients' Surgical Checklist (PASC) will empower surgical patients to become more involved in their own safety and contribute to preventive safety measures. A safety checklist for patients to use has been developed and validated for use in surgical patients. In a Stepped Wedge Cluster RCT effects of patients using their own checklists to avoid preventable patient harm are examined. The project will re-use existing health and personal data collected from patient records and patient reported data as outcome measures. A consortium of all relevant stakeholders and users participate: two hospitals with seven surgical clusters, patient representatives, representatives of general practitioners, and interdisciplinary in-hospital professionals. The important project partners are information and communications technology companies (Helse-Vest IKT and CheckWare service delivery), general practitioners, and national and international research partners leading in the field of patient safety, implementation science and health economics.

NCT ID: NCT03075280 Completed - Complication Clinical Trials

Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in improving patients' early recovery.

NCT ID: NCT03045965 Recruiting - Ovarian Cancer Clinical Trials

Hysterectomy and OPPortunistic SAlpingectomy

HOPPSA
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason - has no increased risk of complications - has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures - implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.

NCT ID: NCT03032471 Terminated - Stroke Clinical Trials

Swiss SOS MoCA - DCI Study

Start date: July 20, 2017
Phase:
Study type: Observational

The primary objective of this multicenter observational study is to determine the effect size of the relationship between DCI and neuropsychological impairment 14-28 days and 3 months after aSAH. Secondary objectives are the feasibility to administer and the validity of the MoCA in an intensive care unit setting, as well as the test/retest reliability of the MoCA in patients with acute brain damage in absence of aSAH.

NCT ID: NCT02954913 Completed - ColoRectal Cancer Clinical Trials

Simultaneous Resection of Colorectal Cancer With Synchronous Liver Metastases

RESECT
Start date: February 14, 2017
Phase: N/A
Study type: Interventional

Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary colorectal tumour and liver metastases within 12 months, is a common problem faced by colorectal and hepatobiliary surgeons.(Adam) The "traditional approach" is to perform staged resections unless the liver resection required is limited (i.e. small wedges of peripheral lesions). The downside of performing staged vs. simultaneous resections is that patients must undergo two major operations instead of one, which limits a patient's ability to return to their pre-surgical state of health in a timely fashion, increasing health care costs (Ejaz) and delaying the start of adjuvant chemotherapy. The disadvantages of a simultaneous approach include longer operating room times potentially increasing the major postoperative complication rate including blood transfusions, surgical site infections, anastomotic leaks and post-hepatectomy liver failure. Recent data from tertiary cancer centres suggest that simultaneous resection of the colon and rectum along with liver resection of any magnitude is feasible and safe.(Silberhumer) Although encouraging, this data comes from specific patients from a highly selected institution, results that are perhaps not generalizable. This proposal is a feasibility study consisting of a pilot single arm prospective study at two different large-volume Hepatobiliary Centres of patients with synchronous colorectal cancer with liver metastases undergoing simultaneous resection of the colon or rectum and liver to evaluate their complication rates (including the calculation of the comprehensive complication index), quality of life, cost evaluation, and proportion of eligible patients recruited over a 12-month period. The results of this pilot study will provide us with the information necessary to build a large multicentre randomized controlled trial comparing staged vs. simultaneous resection for synchronous colorectal cancer liver metastases.

NCT ID: NCT02937610 Completed - Clinical trials for Head and Neck Cancer

Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon

Start date: October 2011
Phase: N/A
Study type: Observational

PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.