Clinical Research Directory

Postoperative Vaginal Compression After Prolapse Surgery - an RCT

The goal of this clinical trial is to learn if omitting postoperative vaginal compression (packing) can facilitate a more efficient recovery after elective surgery for uterovaginal prolapse. The main questions it aims to answer are: Will the omission of vaginal compression result in a non-inferior (unchanged) rate of prolapse recurrence within the first three months after surgery? Does the omission of vaginal compression lead to a shorter hospital stay and a faster return of normal bladder function? Researchers will compare a group that receives no postoperative vaginal compression to a control group that receives standard vaginal gauze packing for two hours to see if skipping the packing leads to shorter hospital stays and faster bladder emptying without increasing the risk of the prolapse returning.

Multimodal AI-Guided Recovery Management After Lung Cancer Surgery

This study is a multicenter, prospective, randomized controlled trial designed to evaluate the effectiveness and safety of a multimodal artificial intelligence (AI)-guided postoperative recovery management system in patients after lung cancer surgery. Eligible patients will be enrolled after surgery when their clinical condition is stable and will be randomly assigned to either an AI-guided recovery management group or a usual postoperative care group. Patients in the AI-guided group will receive usual postoperative care plus a multimodal AI-based recovery management system. The system will collect patient-reported symptoms, vital signs, physical activity, respiratory rehabilitation information, recovery-related data, and, when needed, wound or chest-related images or short videos. Based on these data, the system will provide recovery feedback, general nursing advice, respiratory rehabilitation reminders, activity guidance, and risk stratification alerts. For red-flag symptoms or high-risk conditions, the system will advise patients to contact the clinical team or seek medical care. Patients in the usual-care group will receive standard postoperative management after lung cancer surgery and will complete symptom assessments at the same prespecified time points, but they will not receive AI-generated individualized recovery feedback or AI-generated risk alerts. The primary outcome is the number of MDASI-LC-derived target symptom threshold events within 30 days after surgery. Target symptoms include pain, fatigue, disturbed sleep, shortness of breath, and cough. Secondary outcomes include overall target symptom burden, quality of recovery, time to recovery to a mild-symptom state, functional interference, respiratory rehabilitation adherence, physical activity adherence, unplanned healthcare utilization, pulmonary complications, and unplanned readmission.

Empowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach

The purpose of this clinical trial is to learn about the effects of a nursing support program designed for families of children aged 1 to 3 years who have undergone heart surgery. This program aims to improve parents' caregiving skills and support the healthy growth of their children. The primary questions the study aims to answer are: Does the nursing program positively affect the physical growth of children, such as their height and weight? Does the program improve children's scores on general development tests (Denver II)? Do parents' attitudes toward child feeding and their confidence in parenting skills increase? Researchers will divide participants into two groups: Experimental Group: Families who participate in the nursing education program and receive an informative booklet. Control Group: Families who only receive an informative booklet and continue with routine hospital follow-ups. The researchers will compare these two groups to see if participating in the nursing program leads to better results for the children's development and the families' skills. Participants will be asked to: Attend 5 different education and counseling sessions, starting one week before surgery and continuing until the child reaches 1 year of follow-up. Meet with the researcher at specific intervals (at 1, 2, 3, 6, 9, and 12 months) for one year to monitor the child's development (height, weight, head circumference) and skills. Complete surveys regarding child feeding attitudes and parenting skills at the 6th and 12th month follow-ups.

Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery

Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality. Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively. In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery. IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery. The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.

Effect of Teach-Back-Based Discharge Education in Lower Extremity Surgery Patients

This study aims to determine the effect of discharge education based on the Teach-Back method on patients' learning needs and readiness for hospital discharge following lower extremity surgery. Lower extremity surgeries are associated with pain, limited mobility, and decreased self-care ability, which may negatively affect recovery and quality of life. Effective discharge education is therefore essential to support postoperative recovery and continuity of care. This randomized controlled experimental study will be conducted with patients undergoing lower extremity surgery in an orthopedic clinic. Participants will be randomly assigned to an intervention group receiving Teach-Back-based discharge education and a control group receiving routine discharge education. Data will be collected at three time points (before the intervention, at discharge, and 15 days after discharge) using standardized instruments, including the Readiness for Hospital Discharge Scale-Short Form and the Patient Learning Needs Scale. The findings of this study are expected to contribute to improving discharge education practices, enhancing patient readiness for discharge, and reducing postoperative complications and unmet educational needs.

Rocking Chairs as Post-operative Treatment for Older Adults After Hip Surgery

Feasibility and acceptability randomized controlled trial exploring the use of a rocking chair after a total hip arthroplasty in adults who are aged 65 or older. Primary aims include its feasibility and acceptability; exploratory aims include the impact of rocking on pain, gastrointestinal effects, anxiety, ambulation, and additional healthcare visits.

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.

Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures

The goal of this randomized controlled trial is to assess recovery in patients undergoing benign laparoscopic gynecologic surgery. The main question it aims to answer is: do liberalized postoperative restrictions improve patient recovery after laparoscopic gynecologic surgery? Researchers will compare postoperative recovery surveys from the control group (patients given standard postoperative restrictions limiting activity for 2 weeks) to the research group (patients given liberalized postoperative instructions allowing them to engage in their normal activities of daily life at their own discretion without prescribed activity restrictions) to see if liberalized postoperative restrictions improve the recovery experience. Participants will be asked to fill out a brief questionnaire at two time intervals, 1 week after surgery and 2 weeks after surgery.

CABG-AI-Supported Discharge Education

This randomized controlled trial will evaluate the effectiveness of artificial intelligence-supported individualized discharge education for patients undergoing coronary artery bypass graft (CABG) surgery. Participants will be assigned to either the intervention group, which will receive personalized AI-generated discharge education delivered through a nurse-avatar video in addition to standard verbal education, or the control group, which will receive standard discharge education only. The study will compare postoperative pain, anxiety, physiological stress response, recovery, and satisfaction with discharge education between the two groups. Outcomes will be measured during hospitalization and at the routine postoperative follow-up visit. The findings may help improve patient education methods and postoperative recovery in cardiac surgery patients.

Effect of Postoperative Holistic Nursing Care on Children's Satisfaction and Nursing Image Perception

This randomized controlled study aims to evaluate the effect of holistic nursing care applied during the postoperative period on children's satisfaction with care and their perception of nursing image. The study will be conducted in the Pediatric Surgery Clinic of Antalya Training and Research Hospital with children aged 8 to 11 years who undergo surgical procedures. Participants will be randomly assigned to either an intervention group or a control group. All children will receive routine postoperative nursing care. In addition to routine care, children in the intervention group will participate in a mandala coloring activity accompanied by music. This supportive activity is designed to help children relax, express their feelings, and improve their hospital experience. Data will be collected using standardized questionnaires that measure children's satisfaction with nursing care and their perception of nurses. The study aims to determine whether holistic nursing practices can improve children's satisfaction and positively influence how they perceive the nursing profession.

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Multisensory and Cognitive Interventions in the ICU: Effects on Health and Recovery

The goal of this clinical trial is to examine the effects of sensory and cognitive stimulation on physiological, psychological, and functional recovery in adult patients after cardiac surgery who are treated in the intensive care unit (ICU). The main questions it aims to answer are: * Does sensory and/or cognitive stimulation reduce anxiety and improve hemodynamic stability in ICU patients? * Does it enhance physical function and independence during early rehabilitation in the ICU? Researchers will compare four groups: 1. Standard care (control), 2. Cognitive stimulation, 3. Auditory stimulation (music), 4. Multisensory stimulation (touch + smell) to assess which intervention is most effective in improving recovery parameters. Participants will: * Be randomly assigned to one of four groups during early mobilization in the ICU * Receive a 30-minute intervention session depending on group assignment * Be evaluated for heart rate, blood pressure, oxygen saturation, anxiety (VAS), physical function (PFIT, FIM), and satisfaction before and after the session

Nutrition to Support Postoperative Recovery

Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. However, to date these recommendations do not address a broad group of nutrients likely to reverse common deficiencies. Team members have created a palatable, broad-spectrum and stable nutritional shake that we will give to patients after surgery. We propose to test the nutritional shake in frail older surgical patients at Dartmouth Health to determine if a nutrition shake provided after surgery improves recovery of physical function and cognitive abilities. Half the patients will receive the shake and the other will receive the standard of care postoperative nutritional instructions after surgery. We will collect information regarding physical function and cognitive abilities of all the patients while in the hospital and 90 days after surgery. We will use this data to apply for funding for a powered randomized trial to determine the role of nutrition in optimizing physical and cognitive recovery from surgery in older patients.

Agreement Between ChatGPT-5 and Anesthesiologists in Predicting Postoperative ICU Requirement

Accurate prediction of postoperative intensive care unit (ICU) requirement is essential for patient safety and efficient use of limited ICU resources. In routine clinical practice, decisions regarding postoperative ICU admission are primarily based on anesthesiologists' preoperative clinical judgment, which may vary among clinicians. This prospective, observational study aims to evaluate the agreement between predictions made by ChatGPT-5(Chat Generative Pre-trained Transformer) and anesthesiologists regarding postoperative ICU requirement using routinely collected preoperative patient data, and to compare these predictions with actual postoperative ICU admission outcomes. The study does not involve any intervention, treatment modification, or additional procedures beyond standard clinical care. All patient data are anonymized, and clinical management is not influenced by the model's predictions

Nurse-Led Early Mobilization After Colorectal Surgery

This study was designed to evaluate the effectiveness of a nurse-led early mobilization protocol on postoperative recovery outcomes in patients undergoing elective colorectal surgery. The outcomes assessed include walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, incidence of postoperative complications, and length of hospital stay. Research Question: In patients undergoing colorectal surgery (P), does a nurse-led early mobilization protocol (I), compared with standard mobilization practices (C), improve postoperative recovery outcomes (O), including walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, postoperative complication rates, and length of hospital stay?

Complications of Surgical Geriatrics Hospitalized in the Orinoco Region

The life expectancy of the Colombian population is increasing. Older patients are frequently hospitalized and treated in surgical wards, and are treated as the general surgical population. However, geriatric patients are frequently found with additional comorbidities, besides the primary surgical diagnosis. Some diseases, like hip fractures, diverticulitis, and cancer, are common in this age range. The preoperative, intraoperative, and postoperative period requires a special care and planning to avoid complications related to the physical status, medications, and comorbidities. Studies about the geriatric surgical population are limited in the Orinoco region. The implementation of a comprehensive geriatric assesment in surgical services requires follow-up of outcomes.

Efficacy of Liposomal Bupivacaine Scalp Nerve Block for Postoperative Pain Management After Supratentorial Craniotomy

This is a prospective, randomized, controlled trial conducted at Beijing Tiantan Hospital to evaluate the efficacy and safety of liposomal bupivacaine for scalp nerve block in managing postoperative pain after elective supratentorial craniotomy. A total of 118 eligible patients (aged 18-64, ASA I-III) will be randomly assigned in a 1:1 ratio to one of two groups. The intervention group will receive a scalp nerve block using liposomal bupivacaine. The control group will receive a scalp nerve block using standard 0.5% bupivacaine. All patients will undergo standardized general anesthesia. The primary outcome is postoperative pain intensity, measured by the Numerical Rating Scale (NRS) at multiple time points: 2, 12, 24, 48, and 72 hours after surgery. Secondary outcomes include the Glasgow Coma Scale (GCS) score, patient satisfaction, cumulative opioid consumption, and the incidence of adverse events. The study aims to determine if a single administration of liposomal bupivacaine provides superior and prolonged analgesia compared to conventional bupivacaine, potentially improving pain management and recovery for craniotomy patients. The study duration is from October 2024 to May 2027.

Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis

Investigators tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.

Prevention of Rebound Pain After Axillary Block

This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Machine Learning for Predicting Spinal Anesthesia Duration

Spinal anesthesia provides significant advantages over general anesthesia in knee arthroplasty, including reduced blood loss, faster recovery, and fewer complications. However, predicting its duration is critical for patient safety and effective postoperative management. This study evaluates the usability of machine learning (ML) algorithms to predict the termination time of spinal anesthesia and the patient's readiness for mobilization. Using demographic, surgical, and anesthetic variables, ML models were trained to estimate anesthesia duration. Accurate predictions may improve intraoperative planning, optimize postoperative care, and enhance patient outcomes. Integrating ML-based predictive systems into anesthesia practice can contribute to safer, more efficient, and personalized perioperative management.

Romanian Validation and Cross-cultural Adaptation of the QoR-15Ro

Optimal postoperative recovery after any surgical procedure requiring anesthesia is essential to achieving high-quality care. The Quality of Recovery questionnaire (QoR-15) was validated by its authors in 2013 in the study "Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15." This instrument enables a comprehensive evaluation by integrating traditional physiological measures with the patient's subjective perception of their health status. With the consent of the original author, the present study aims to validate the Romanian version of the questionnaire and adapt it to our clinical environment.

PAN-ICIS Study: ICIS for Early Detection of Infectious Complications in Pancreatic Surgery

This study examines a new blood test called ICIS, which may help detect infections earlier after pancreatic surgery. Patients will have routine blood samples taken during their hospital stay, with no extra procedures required. By tracking how ICIS changes over time, investigators aim to improve early infection detection, support safer recovery, and reduce postoperative complications.

Sedation With Dexmedetomidine-esketamine Combination and Delirium in ICU Patients

Patients in the intensive care unit (ICU) often develop anxiety and agitation, sleep disturbances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in postoperative ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the neuropsychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in postoperative ICU patients may reduce delirium.

Posthectomy in Pediatric Elective Surgery : a Comparison of Perioperative Analgesia Using Echo-guided Penile Block and Pudendal Block With neurostimuLation Technique

Context : Posthectomy is a surgical procedure that concerns around 30% of the male population, mainly in pediatrics. As this procedure is mainly performed on an outpatient basis, the implementation of an enhanced rehabilitation protocol after surgery in pediatrics helps to reduce the incidence of postoperative pain, notably by providing multimodal analgesia, including locoregional anesthesia. Current recommendations from pediatric locoregional anesthesia societies favor penile block and the use of ultrasound in pediatric anesthesia to reduce anesthetic set-up time and the volume of local anesthetic, but also to increase the duration of sensory block and the success rate. However, several studies have shown the inferiority of penile block in anatomical landmarks compared with pudendal block under neurostimulation. As a result, pediatric anesthesiologists at Caen University Hospital prefer to use pudendal blocks under neurostimulation for posthectomy surgery. To date, no study has compared penile block under ultrasound with pudendal block under neurostimulation for postoperative analgesia after posthectomy surgery. On the other hand, a study of postoperative analgesia in hypospadias surgery showed a clear superiority of penile block under ultrasound over pudendal block in terms of both immediate postoperative pain and duration of postoperative analgesia. It therefore seems pertinent to compare these two techniques in posthectomy surgery. Objective: We propose a prospective, open-label, non-inferiority study with the primary objective of comparing the efficacy of echo-guided penile block versus pudendal block in neurostimulation for posthectomy surgery. Methods: This randomized, single-center study will include 240 patients divided into two groups. The experimental group will receive optimized medical and surgical management, with a penile block under ultrasound, while the control group will receive a pudendal block under neurostimulation. The planned duration of the study is 3 years. Hypothesis tested: We hypothesize that ultrasound-guided penile block is non-inferior to neurostimulated pudendal block for postoperative analgesia in scheduled posthectomy surgery. The secondary objectives are to evaluate the time taken to perform the block, the volume of local anesthetic used, the need for sufentanil reinjection intraoperatively, the quantitative evaluation of analgesia using the EVENDOL score, the consumption of nalbuphine in the post anesthesia care unit, the occurrence of postoperative vomiting, and the length of stay in the post anesthesia care unit. The rate of complications related to the performance of locoregional anesthesia is also observed.