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Complication clinical trials

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NCT ID: NCT06146270 Not yet recruiting - Surgery Clinical Trials

Russian Registry of Surgical OutcomeS

RuSOS
Start date: March 1, 2024
Phase:
Study type: Observational

Identification of risk factors that cause a high probability of an unfavorable outcome in the postoperative period is an urgent problem. The creation of national databases (registries) makes it possible to maximally cover a certain patient population by identifying its characteristic risk predictors. As literature data show, existing registries differ in the criteria for inclusion in the study, in the characteristics of the populations studied, and there is often no common view on the classification of postoperative outcomes. Goal of a study is a creation of a Russian national calculator for the risk of postoperative complications and mortality. Two-level observational retrospective-prospective study was planned. Setting: National multicenter study of surgical inpatients. Patients: Adult patients undergoing elective and emergency surgery. Types of interventions: in obstetrics, in gynecology, on the breast, in urology and kidneys, in endocrine surgery, in maxillofacial surgery, in orthopedics and traumatology, on the lower floor of the abdominal cavity, on the liver and biliary tract, on the upper floor of the abdominal cavity cavities, in thoracic surgery, in vascular surgery, in neurosurgery, in cardiac surgery, in other areas (with mandatory specification). The study was organized by the Federation of Anesthesiologists and Reanimatologists of Russia. Primary (30-day mortality, 30-day complications) and secondary (hospital mortality, hospital complications, length of stay in anesthesiology, resuscitation and intensive care departments, length of hospital stay, multiple organ failure (2 or more points on the SOFA scale (Sequential)) Organ Failure Assessment), 90-day mortality, 90-day complications, intensive care after-effects syndrome, readmission, 1-year mortality) outcomes were determined. The required sample size and statistical analysis methods are described. The planned duration of the study is 2024-2028.

NCT ID: NCT05761275 Not yet recruiting - Quality of Life Clinical Trials

Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery. The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation/aspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.

NCT ID: NCT05617846 Not yet recruiting - Complication Clinical Trials

Application of Antiosteoporosis Therapy in Osteolysis

Start date: December 28, 2024
Phase:
Study type: Observational

To report the postoperative complications and limb function of patients with osteolysis after surgery for bone tumors of the extremities who received anti-osteoporosis therapy in Henan Cancer Hospital in the next 10 years.

NCT ID: NCT04576234 Not yet recruiting - Complication Clinical Trials

Comparative Study Between Two Routes of Enteral Feeding

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

The study assess, evaluate and compare the efficacy of two methods of enteral feeding on complications and nutritional status among ICU patients. The study had utilized two methods of enteral feeding consisted of intermittent enteral feeding by syringe pump and hospital blended enteral feeding by feeding bag and assess the patient before and after feeding for 10 days by using three tools help to monitor hemodynamic parameters, GIT system assessment and laboratory findings assessment which help to evaluate nutritional status and complications. The results showed that the complications in the intermittent enteral feeding group were lower than those in feeding bag group.

NCT ID: NCT04037982 Not yet recruiting - Death Clinical Trials

RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors

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

Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.

NCT ID: NCT03864939 Not yet recruiting - Complication Clinical Trials

Application of Dried Human Amnion Graft to Improve Postprostatectomy Incontinence and Potency

Start date: April 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP) in a tertiary center in Germany.

NCT ID: NCT02744937 Not yet recruiting - Complication Clinical Trials

Continuing Low Dose Aspirin Before Prostate Biopsy

Start date: April 2016
Phase: Phase 4
Study type: Interventional

Objectives: To determine whether TRUS-guided prostate biopsy performed in patients continuing low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of bleeding complications. Eligibility: Men over 40-year-old with an elevated serum prostate-specific antigen level and/or abnormal digital rectal examination findings are candidates for PB. Design of trial Prospective Randomized Trial Study treatment: Continuing low-Dose aspirin before transrectal prostate biopsy Primary endpoint: The incidence, duration, and severity of bleeding complications Statistical analysis and sample size estimation: Fisher's exact test or chi-square test will be used to explore the differences between two groups for categorical variables, and Student t-test will be used for continuous variables. Under the assumption of a difference of 25% of bleeding complications in each group, with α=0.05 and power=0.80, 60 subject are needed in each arm. Assuming the drop-out rate to be 20%, the targeted recruit number is 150 in total.

NCT ID: NCT02732613 Not yet recruiting - Body Weight Clinical Trials

Selection of Laryngeal Mask Airway in Patients With Slender Somatotype

Start date: April 2016
Phase: N/A
Study type: Interventional

The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's recommendation based on the patient's ideal weight. But sometimes the patient is tall and slim, the actual weight is much less than the ideal weight. This phenomenon might affect the success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal Mask Airway size based on ideal weight could improve the success rate of insertion; therefore, this study was designed to prove whether this conclusion also applies to the tall and thin patients.