Clinical Research Directory

ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.

In this study cameras placed at the bedside will be evaluated for their ability to safely and accurately measure vital signs, such as heart rate and breathing, continuously after heart surgery. Camera-based measurements will be compared with the usual checks that nurses perform several times a day using sensors on the skin or finger clip. The goal is to see whether camera monitoring can help notice changes in a patient's condition earlier. Another aim of the study is to find out whether the camera monitoring can predict if a patient's health is improving or worsening. Patients and healthcare staff will be asked by the investigators about their experience to learn whether this type of monitoring is acceptable in daily care.

Surgeons' Prediction of Dental Surgery Complications and the Influence of Patient Characteristics: Development of an AI Model

The goal of this observational study is to learn how to better predict and prevent intra- and postoperative complications in oral surgery in adult patients referred for oral surgical procedures. The study aims to understand how accurately surgeons can foresee complications and which patient, tooth, and surgery related factors influence the outcomes. The research questions are: * What is the incidence of intra and postoperative complications in oral surgery? * Which factors predict these complications, and how accurately can surgeons anticipate them? * Can the development of an AI tool reduce postoperative complications? Participants will: * Receive standard oral surgery treatment at a private referral clinic (Specialtandlægerne Sjælland). * Have clinical information collected about their procedure, medical history, and personal characteristics (including anxiety level). * Conduct a short questionnaire, the STAI-6 and the I-PANAS-SF. * Have the surgeon record their prediction of whether complications are expected. * Be followed in the postoperative lapse to document whether complications occur after surgery.

Hysterectomy and OPPortunistic SAlpingectomy

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.

Predictive Value of Preoperative Rectus and Diaphragm Muscle Thickness for Postoperative Complications in Gastrointestinal Cancer Surgery

The aim of this observational study is to investigate the relationship between preoperative rectus abdominis and diaphragm muscle thickness and postoperative complication rates in patients undergoing surgery for gastrointestinal system malignancies. The main research question is whether rectus abdominis and diaphragm muscle thickness can be used to predict postoperative complications in these patients, and whether there are specific cut-off values for these muscle thicknesses. Participants will be selected from operable gastrointestinal malignancy cases, and preoperative measurements of rectus abdominis and diaphragm muscle thickness will be performed using ultrasonography.

Lipid Balance in Adult Sickle Cell Patients

This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.

Complications of the Alveolar Opening Maneuver in Children on Mechanical Ventilation

The objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). These procedures are part of the standard care provided in the Pediatric Intensive Care Unit (PICU) and are used to improve pulmonary oxygenation and respiratory mechanics. Through this study, we aim to gather information that will help improve the safety and effectiveness of these interventions in critically ill patients.

Frailty in Outpatient Digestive Endoscopy

The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures. A geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications. The questions we want to try to answer are: * Prevalence and severity of fragility in digestive endoscopy. * Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.

Study of Post-anesthesia Management in Patients Undergoing Neurosurgery

The postoperative complications of neurosurgery are various and complex, which brings heavy economic and social burden to families. Timely detection and early intervention can help reduce the incidence of adverse events and mortality. The main purpose of this study is to analyze the possible factors related to postoperative complications of Neurosurgery, so as to achieve the prospective prevention and treatment of postoperative complications of neurosurgery.

Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)

Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.

Esophageal Protection Study: A Multicenter Study

Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the esophagus caused by thermal energy being transmitted to the esophagus from the heart. The esophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe esophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the esophagus from ablation-related injury compared to the standard care temperature monitoring probe currently used. The ensoETM is a CE marked and FDA-cleared device, with an intended purpose of controlling patient temperature and has received marketing authorization from FDA to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. The purpose of this study is to determine if the long-term efficacy outcome results obtained in single pilot studies can be replicated in a prospective, multi-center randomized controlled trail comparing the the esophageal cooling probe versus a standard of care esophageal temperature monitoring probe. There is a 50:50 chance of the esophageal cooling probe being used during AF ablation for participants.

Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site

Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.

Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

Russian Registry of Surgical OutcomeS

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.

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

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.

SEBBIN Round, Anatomical and Biconvex Gluteal Implants

This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

SEBBIN Silicone Gel-filled Testicular Implants

This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery

During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas of vascular suffering of the skin that sometimes cause necrosis of the same. Skin necrosis is the most important adverse event in oncoplastic and reconstructive surgery of the breast, since it causes delays in adjuvant treatments to surgery, worsening of the cosmetic result, and, on occasions, loss of the implant and reconstruction. Indocyanine color green (ICG) angiography has been proposed as a diagnostic alternative to determine the vascular perfusion of the skin envelope of the breast during surgery, which would allow the removal of tissue at risk of necrosis to avoid this complication during the postoperative period. However, the scientific literature does not currently allow an adequate assessment of this diagnostic procedure due to the absence of prospective studies that have evaluated its sensitivity, specificity, and predictive values. The objective of this prospective study is to evaluate ICG angiography of skin flaps of the breast and the surgeon's decision in women with breast cancer or at high risk for breast cancer undergoing oncoplastic surgery or mastectomy with the help of skin or skin-nipple. Based on the results of this study, the sensitivity, specificity, and predictive values of this technique for the prediction of adverse events during the postoperative period will be established.

Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

This protocol describes a prospective cohort study. It addresses an important challenge in the prevention of colorectal cancer and duodenal cancer: how to safely and effectively remove large polyps.

Cold Snare Endoscopic Mucosal Resection Trial

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer

The primary focus in this study is to investigate and improve the surgical technique. In addition the collection of clinical data during diagnostic and follow up and the collection of tumor and blood gives us the opportunity to investigate tumor biology and its relevance in terms of determine appropriate treatment strategy both surgically and oncological and to assess and predict treatment outcome. The aim of this study is to compare short and long-term outcomes between open D3 and laparoscopic CME (complete mesocolic excision) with CVL (central vascular ligation) right colectomy for right-sided colon cancer. Our primary hypothesis is that laparoscopic surgery improves quality of life by reducing pain, postoperative complications and thereby reduces hospital stay and convalescence. On the other hand it is to prove non-inferiority of the laparoscopic group compared to the open group by means of oncological outcome (survival, recurrence). Secondary aim is to evaluate surgical quality by comparing actual vascular stump length between the two groups by postoperative CT and compare number of lymph nodes removed with the specimen. With the use of liquid biopsy we want to detect circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) and evaluate their value as tumor markers by comparing the prognostic and predictive value. The hypothesis is that ctDNA and CTCs are more sensitive than standard parameters and imaging (CT CEA).

PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and/or Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.

This is a prospective, multicentre, phase III, randomised, controlled intervention study. Two groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). Each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). \- PASCA interventional group For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary. \- Control group For the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management. =\> For all patients, regardless of group All patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications: * Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and/or the start of his or her consolidation treatment. * Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment; * Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment; * Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.

Application of Antiosteoporosis Therapy in Osteolysis

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.

Real World Study of End-stage Liver Disease in China

The aims of this study are exploring the current situation of end-stage liver disease in China, and the optimization of diagnosis and treatment. Liver cirrhosis often accompanied by a series of complications. Therefore, it is necessary to standardize the diagnosis and treatment of liver cirrhosis and its complications. End-stage liver disease mainly refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that liver function can not meet the physiological needs of human body. This study is a single-center, prospective and observational real-world study aimed at investigating and analyzing the current diagnosis and treatment of liver cirrhosis and end-stage liver disease in China.