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Surgery clinical trials

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NCT ID: NCT04434066 Active, not recruiting - Surgery Clinical Trials

Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

Start date: January 8, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.

NCT ID: NCT04419597 Active, not recruiting - Surgery Clinical Trials

Hemopatch Safety and Efficacy Evaluation Versus Standard Practice for Sealing the Dura in Cerebrospinal Fluid Leaks

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

Posterior fossa surgeries are generally complicated by difficulties in creating a watertight dural closure, which often requires the use of dural substitutes. In particular, surgical procedures at this location are associated with an increased rate of fluid leakage (cerebrospinal fluid (CSF)) or inflow (blood, air, etc.) creating hydrodynamic complications. Effective sealing of the dura is required to prevent such complications and infections by minimizing the introduction of irritating blood products into the CSF. Since true hermetic dural seals are often impossible to achieve, dural sealants have been developed that can be applied to the sutured dural perimeter to help prevent complications related to CSF. Adjuvant use of such sealants may be prudent, particularly in posterior fossa surgeries, as the incidence of CSF leakage has been reported to be as high as approximately 15-28% with such surgeries, with an increased risk of leakage. 5.84 times greater than supratentorial procedures.

NCT ID: NCT04415138 Active, not recruiting - Surgery Clinical Trials

Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System

Start date: March 10, 2020
Phase:
Study type: Observational [Patient Registry]

Robotic assistance allows performance of mitral valve operations with a truly minimally invasive and totally thoracoscopic approach, with significant advantages for patients compared to sternotomy-based surgery. Nonetheless, its diffusion has been limited by: 1) significant learning curve and technical requirements; 2) increased immediate financial costs due to dedicated equipment and materials. The aim of the present study is to perform a prospective data collection and evaluation of the in-hospital and follow-up clinical results of mitral valve repair using the last generation DaVinci X robotic platform. A cost-effectiveness analysis of this approach will be also conducted, under a global healthcare system perspective (including the overall patients' pathway starting from diagnosis of mitral valve disease until the completion of the 1st postoperative year). Since the 'competitor' surgical technique is not represented by sternotomy-based mitral surgery, but instead by minimally invasive, video-assisted mitral surgery, patients operated on using such technique will serve as controls.

NCT ID: NCT04410419 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Carbohydrate Loading and Diabetes in Colorectal Surgery

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04379921 Active, not recruiting - Surgery Clinical Trials

Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch

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

One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.

NCT ID: NCT04218812 Active, not recruiting - Surgery Clinical Trials

Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation

PROMAESIS
Start date: March 12, 2019
Phase: N/A
Study type: Interventional

Electrical source imaging is part of the presurgical evaluation of patients with drug-resistant focal epilepsy. The software packages that will be used in this study have Declaration of Conformity within the European Economic Area (CE mark) for this specific medical use. In spite of being part of the clinical standard, the evidence for the accuracy and clinical utility of these methods are derived from several smaller-scale and retrospective studies. The PROMAESIS study will provide solid evidence of the accuracy and clinical utility of automated ESI.

NCT ID: NCT04198714 Active, not recruiting - Surgery Clinical Trials

Pudendal Nerve Block in Vaginal Surgery

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

The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.

NCT ID: NCT04175743 Active, not recruiting - Surgery Clinical Trials

Double-blind, Placebo-control, Study to Evaluate the Safety and Pharmacokinetics of CT-044 HCl, in Healthy Volunteers

Start date: December 4, 2019
Phase: Phase 1
Study type: Interventional

This study will be conducted to assess safety, tolerability, and PK of CT-044 HCl in normal healthy volunteers, in a traditional sequential multiple ascending dose paradigm. The multiple-dose escalation is designed to mimic the manner in which the product (CT-044 HCl) would be used to manage ongoing pain in patients (i.e., multiple dosing).

NCT ID: NCT04171297 Active, not recruiting - Surgery Clinical Trials

Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery

IDEA1
Start date: September 25, 2019
Phase:
Study type: Observational

An international multicenter observation study to evaluate the diagnostic accuracy and predictive value of ultrasound using the IDEA terminology in the detection of deep endometriosis in women scheduled for surgery.

NCT ID: NCT04127864 Active, not recruiting - Colorectal Cancer Clinical Trials

Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery

TruCulture
Start date: October 14, 2019
Phase:
Study type: Observational

At Zealand University Hospital, Denmark, the investigators will examine the immune function of patients with colorectal cancer before and after tumor resection. The immune function will be assessed with functional profiling of the immune function (TruCulture®) The study aims to describe alterations in the perioperative immune response to surgery. The generatied knowledge will lead to better under standing of perioperative pathophysiology.