Clinical Research Directory

Intraoperative Targeted Versus Liberal Blood Pressure Management in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

The goal of this clinical trial is to learn whether two approaches to anesthesia and blood pressure management can improve care for adults having off-pump coronary artery bypass grafting (OPCAB). OPCAB is a type of heart bypass surgery performed without routinely using a heart-lung machine. The main questions this study aims to answer are: * Does keeping mean arterial pressure (MAP), a measure of average blood pressure, at 65 mm Hg or higher during surgery lower the chance of major complications or death within 30 days after surgery compared with usual clinician-directed blood pressure management? * Does remimazolam provide more stable blood pressure and heart rate than propofol when used to maintain general anesthesia during surgery? The researchers expect that targeted blood pressure management may lower the chance of major postoperative complications. They also expect that remimazolam may provide more stable blood pressure and heart rate than propofol. Researchers plan to enroll 416 adults having elective OPCAB surgery. Participants will be randomly assigned to one of four groups. Each group will receive one of two blood pressure strategies and one of two medicines for maintaining general anesthesia. Participants will: * Receive either targeted blood pressure management or usual clinician-directed blood pressure management during surgery. * Receive either remimazolam or propofol to maintain general anesthesia after the same standard anesthesia induction. * Have routine monitoring during surgery and assessments during recovery after surgery. * Complete follow-up assessments after surgery, including assessments of complications, recovery, and longer-term health. Some participants will also provide blood samples for a biomarker substudy. The study will also explore whether the effect of the blood pressure strategy differs depending on which anesthetic medicine is used.

Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes

Axillary web syndrome (AWS), sometimes called "cording," is a condition that can develop after breast cancer surgery in which the lymph nodes under the arm are removed or sampled. It appears as one or more tight, painful cord-like structures running from the armpit down the inner arm. It can limit shoulder movement, cause pain, and interfere with daily activities. It is not yet clear how often AWS occurs, when it typically appears after surgery, which patients are most likely to develop it, or whether it is related to the arm swelling (lymphedema) that some patients experience after breast cancer treatment. Most previous studies looked back at patient records rather than following patients forward in time, so the answers remain uncertain. In this study, women who are having breast cancer surgery with either sentinel lymph node biopsy or axillary lymph node dissection will be examined before their operation and then at set times afterward: 2, 4, and 8 weeks, and 3 and 6 months. At each visit, the study doctor will examine the armpit and arm for cords, measure how far the shoulder can move, ask the patient to rate any pain, and measure the circumference of both arms to check for swelling. The study does not change the surgery or treatment a patient receives. It adds only these examinations and measurements, which are not painful and do not require blood tests or imaging. The researchers hope the results will help identify which patients are at higher risk, so that rehabilitation can be started earlier.

CT Volumetry and Hepatic Vascular Deformation Mapping to Predict Post-Hepatectomy Liver Failure

Removing a large part of the liver (major hepatectomy) can cure primary and secondary liver cancers, but it carries the risk of post-hepatectomy liver failure (PHLF), a serious complication in which the liver left behind - the future liver remnant (FLR) - cannot meet the body's metabolic needs. PHLF occurs after roughly 5% to 15% of major hepatectomies and is the leading cause of postoperative death. Before surgery, surgeons routinely use CT scans to measure how much liver will remain (CT volumetry). Volume alone does not tell the whole story. After a large resection the remaining liver can rotate and shift into the empty space left behind, kinking or compressing the veins that drain it. The resulting congestion can make an apparently adequate remnant fail. This prospective, multicenter, observational cohort study tests whether adding two elements to standard CT volumetry improves the preoperative prediction of liver failure: 1. Hepatic vascular deformation mapping (VDM), a three-dimensional image-analysis technique that quantifies the geometry and displacement of the hepatic veins and the portal vein; and 2. A set of simple, reproducible measurements that any radiologist can make on a standard CT scan (hepatic vein diameters, congestion index, spleen volume, liver attenuation, and the distances from the veins to the planned resection plane). Consecutive adults undergoing major hepatic resection (three or more Couinaud segments) at several tertiary hepatobiliary centers will be enrolled. The preoperative CT scans already performed as part of routine care are analyzed centrally by a core imaging laboratory. There is no additional imaging, no extra hospital visit, and no study-specific intervention: every patient receives standard surgical care. Participants are followed for at least 30 days after surgery to record liver failure (International Study Group of Liver Surgery criteria, operationalized by the "50-50" rule on postoperative day 5) and radiologic evidence of hepatic congestion. Three nested prediction models are compared - volumetry alone; volumetry plus VDM; and volumetry plus VDM plus the simple radiology parameters - and the best-performing model is converted into a practical risk score. Because the study runs across several centers, the model can be validated by leaving one center out at a time, which gives an honest estimate of how well it would perform at a new hospital. The goal is a generalizable, easy-to-use tool that tells surgeons, before the operation, which patients are genuinely at risk of post-hepatectomy liver failure.

Hernia Sac Flap Coverage of Mesh in Bony-Edged Ventral Hernia Repair

This trial asks whether covering the inner, bowel-facing surface of a hernia mesh with a flap of the patient's own hernia sac improves healing after repair of a complex ventral (abdominal wall) hernia in which one edge of the defect is bone - for example hernias next to the breastbone and ribs, above the pubic bone, or at the iliac crest. In these "bony-edged" hernias the mesh is both hardest to fix and hardest to cover. There is no fascia on the bony side for the surgeon to stitch the mesh to, and the lining layer of the abdomen cannot be closed underneath the mesh because the plane that carries it stops at the bone. The mesh may therefore be left in contact with the bowel, which can lead to dense adhesions, mesh erosion, chronic pain and, rarely, a fistula. Normally the hernia sac - the thin membrane that lines the hernia - is cut away and discarded. In this trial the surgeon instead preserves it as a living, blood-supplied flap, rotates it underneath the mesh, and stitches it in place as a new lining layer that separates the mesh from the bowel and covers the bony edge. The technique uses only the patient's own tissue: no extra mesh, no donor site and no added cost. One hundred and eighty adults undergoing planned (non-emergency) open repair of a bony-edged complex ventral hernia will be randomly assigned in equal numbers to one of two groups: standard retromuscular (sublay) mesh repair with the added sac flap (90 participants), or standard retromuscular mesh repair alone, with the sac handled in the conventional way (90 participants). Every other step of the operation is the same in both groups. The main question is whether the sac flap reduces the number of participants who develop any wound or mesh problem in the first 30 days after surgery. This is measured as a composite called a surgical site occurrence, which includes wound infection, seroma, haematoma, skin or soft-tissue death, wound breakdown, mesh exposure and fistula. The trial also compares complications needing a drainage or operative procedure, hernia recurrence at 12 months, overall complication severity, operating time, blood loss, hospital stay, readmission, reoperation, pain, quality of life and death. Participants, ward and clinic staff, the doctors who assess the wounds, the radiologist who reads the follow-up scans and the trial statistician will not know which operation was performed; only the operating surgeon will. The group assignment is revealed only during the operation, after the surgeon has confirmed that the defect truly has a bony edge and that the sac is suitable for a flap. Participants are followed for 12 months.

Postoperative Hypocalcemia After Thyroidectomy

This retrospective cohort study investigates predictors of postoperative hypocalcemia following thyroidectomy procedures at Minia University Hospital over a 10-year period (2014-2024). Postthyroidectomy hypocalcemia is one of the most common complications of thyroid surgery, affecting 20-50% of patients. The study aims to identify demographic, clinical, laboratory, and surgical factors associated with the development of both transient and permanent hypocalcemia. Results will inform risk stratification, patient counseling, and perioperative management strategies.

Enhanced Recovery After Urogynaecological Surgery - Early Urinary Catheter Removal in an Asian Population

It is estimated that more than 50% of parous women are impaired by pelvic organ prolapse (POP). By 85 years of age, 11-19% of women will have undergone at least one operation for POP, and this is expected to increase due to Singapore's aging population. Currently, locally, patients remain inpatient for minimum 2 days post-operatively as removal of indwelling catheter (IDC) and trial of void is done on 1st to 2nd post operative day. However, there is a trend towards same-day surgery and same-day removal of IDC in western populations with good success (ranging 40-90% success). Inpatient stays can be prolonged due to voiding dysfunction after removal of IDC which require reinsertion of IDC and another trial of void the next day. Thus, the investigators seek to investigate if removal of IDC is feasible on first post-operative day. If successful, this will change current local practice, improve time to ambulation and reduce length of hospital stay and costs. Early catheter removal after pelvic organ prolapse surgery reduces time to spontaneous void, post-void residual volume, length of admission, and pain score. Aims: 1. To investigate if early catheter removal reduces time to spontaneous void and post-void residual urine volume or risks of urinary retention 2. To determine if early catheter removal results in earlier ambulation and shorter length of admission. 3. To determine if patient satisfaction is improved with early catheter removal.

Effectiveness of Hypotension Prediction Index (HPI) in Preventing Hypotension in the Post-Anesthesia Care Unit (PACU)

Postoperative hypotension in the post-anesthesia care unit (PACU) is common and linked to adverse outcomes. The Hypotension Prediction Index (HPI) predicts hypotensive events intraoperatively, but its PACU application is unexplored. This study aims to investigate the effectiveness of HPI-guided monitoring in preventing PACU hypotension.

Perioperative HALP and Surgical Outcomes

Esophagectomy is associated with substantial postoperative morbidity despite advances in perioperative care. The Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) score has been proposed as a composite biomarker reflecting nutritional, inflammatory, and immune status; however, its perioperative behavior and clinical significance after esophagectomy remain unclear. This retrospective cohort study evaluates perioperative changes in HALP and examines the associations of preoperative, postoperative day 1, and postoperative day 7 HALP measurements with postoperative complications, including overall and major complications, anastomotic leakage, ICU readmission, and length of hospital stay. The study aims to clarify the potential role of perioperative HALP as a marker of postoperative recovery and adverse clinical outcomes following esophagectomy.

DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction

This multicenter retrospective observational study will develop and validate a CTA-based quantitative risk score-the DIEP Morphological Deviation Score (DIEP-MDS)-to estimate the risk of flap-related vascular compromise and flap failure in patients undergoing DIEP flap breast reconstruction. The score will quantify the extent to which an individual's perforator anatomy deviates from normative anatomic distributions derived from a reference population of individuals without breast cancer or reconstructive surgery. Specifically, a cohort of randomly selected individuals with available CTA imaging will be used to establish population-level reference distributions for key anatomic features relevant to DIEP perforator morphology, including length, diameter, and muscle thickness. The study will determine whether greater deviation in DIEP morphology, as quantified by the DIEP-MDS, is associated with an increased risk of flap-related vascular compromise and flap failure. The score will be evaluated in an internal surgical cohort and externally validated in an independent multicenter surgical cohort. In addition, the study will pre-specify an analysis to assess whether a dual-pedicle strategy is associated with a lower risk of flap-related vascular compromise compared with a single-pedicle strategy across DIEP-MDS risk strata.

GNRI and Rectus Femoris Muscle Thickness in Older Patients Undergoing Hip Fracture Surgery

This prospective observational study will evaluate whether nutritional risk and reduced muscle mass are associated with postoperative outcomes in adults aged 65 years or older undergoing surgery for hip fracture. Nutritional risk will be assessed using the Geriatric Nutritional Risk Index (GNRI), which is calculated from routine preoperative serum albumin, body weight, and ideal body weight. Rectus femoris muscle thickness will be measured before surgery using a brief, noninvasive ultrasound examination of the non-fractured thigh. Participants will receive routine clinical care, and no treatment or anesthesia method will be assigned by the study. Clinical information will be collected from hospital records, including postoperative length of hospital stay, surgical site infection, and mortality. Survival status will be evaluated at 30 and 90 days after surgery using hospital records and/or telephone follow-up.

The Impact of Intra-Abdominal Pressure on Mortality and Morbidity in Patients Undergoing Open-Heart Surgery

This prospective observational study evaluated whether increased intra-abdominal pressure, meaning increased pressure inside the abdomen, is associated with postoperative complications and mortality in adults undergoing elective open-heart surgery with cardiopulmonary bypass. Intra-abdominal pressure was measured through the urinary bladder at three time points: after anesthesia induction, after closure of the sternum, and two hours after admission to the intensive care unit. Participants with an intra-abdominal pressure of 12 mmHg or higher at any measurement were compared with those whose pressure remained below 12 mmHg. The study examined postoperative recovery outcomes, including time to extubation, length of stay in the intensive care unit and hospital, postoperative complications, and mortality. It also aimed to identify perioperative factors associated with increased intra-abdominal pressure. No study-specific treatment or intervention was assigned, and all patients received standard perioperative care.

A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children

The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) undergoing transcatheter device closure. The main question it aims to answer is: Can an AI model that integrates demographics, laboratory results, electronic health record text, echocardiography reports, chest radiographs, and electrocardiogram accurately predict the risk of complications at the individual patient level? Data will be retrospectively collected from routine clinical care records of pediatric patients who underwent transcatheter closure for pmVSD. Deep learning methods will be used to extract features from text and images to train and validate the prediction model.

PTSD of Surgeons or Anesthesiologists on Prognosis of Surgical Patients

The objective of this prospective cohort study is to explore the association between the development of post-traumatic stress disorder (PTSD) in surgeons and anesthesiologists and postoperative prognosis in surgical patients they care for during the COVID-19 pandemic. There are 2 cohorts included in this study. The first cohort consists of registered surgeons and anesthesiologists in the study center. The development of PTSD will be evaluated with a series of questionnaires and scales. This cohort defines exposure (with PTSD). The second cohort consists of surgical patients managed by the surgeons and anesthesiologists in the first cohort. The postoperative outcome of these patients will be evaluated thus to explore the association between PTSD in physicians and adverse patient outcomes. The second cohort defines the outcomes( response).

Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)

The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access). The main questions it aims to answer are: Does using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing? Researchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI. Participants will: Undergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care. Receive an initial single-suture placement before the large TAVI delivery system is inserted. Be evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group). Have their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge. Complete a 72-hour safety and complication evaluation.

Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study

Liver resection is an important surgical treatment for patients with liver diseases. Despite advances in surgical and anesthetic management, postoperative complications remain a major concern and may affect patient recovery. Maintaining stable blood circulation during surgery is an important part of perioperative care. Terlipressin is a vasoactive medication that may help maintain blood pressure and improve hemodynamic stability during surgery. However, the relationship between intraoperative continuous terlipressin infusion and postoperative outcomes after laparoscopic hepatectomy remains unclear. This prospective observational cohort study aims to evaluate the association between continuous intraoperative terlipressin infusion and postoperative severe complications in patients undergoing laparoscopic hepatectomy. Patients undergoing laparoscopic hepatectomy at the First Affiliated Hospital of Sun Yat-sen University will be enrolled and followed according to a predefined study protocol. Perioperative clinical information, anesthetic management data, terlipressin exposure, and postoperative outcomes will be collected and analyzed. The primary outcome is the occurrence of severe postoperative complications, defined as Clavien-Dindo grade III or higher complications.

Clinical Effects of Intraoperative Heat and Moisture Exchange Systems During Thoracic Surgery: A Prospective Observational Cohort Study

General anesthesia with endotracheal intubation bypasses the physiological warming and humidification functions of the upper airway, allowing cold and dry gases to reach the lower respiratory tract. This may impair mucociliary clearance, increase secretion viscosity, promote atelectasis, and contribute to postoperative pulmonary complications (PPCs). Patients undergoing thoracic surgery, particularly those requiring one-lung ventilation (OLV), are at increased risk for PPCs because of altered ventilation-perfusion matching, reduced functional residual capacity, and impaired secretion clearance. Although respiratory gas humidification is routinely used during anesthesia, evidence regarding the comparative clinical effects of active heated humidification (AHH) and passive heat and moisture exchangers (HMEs) during thoracic surgery remains limited. This prospective observational cohort study aims to evaluate the association between intraoperative respiratory gas humidification methods and postoperative pulmonary complications and perioperative clinical outcomes in adult patients undergoing elective video-assisted thoracoscopic surgery (VATS).

Impact of a Transmission Checklist in Post Anesthesia Care Unit on Immediate Respiratory Complications

This work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted.

Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery

This study evaluates the usefulness of bioelectrical impedance analysis (BIA) for perioperative fluid evaluation and prediction of postoperative complications in oncological patients undergoing colorectal surgery. Bioelectrical impedance analysis is used to assess body fluid status and body composition before and after surgery. The study aims to determine whether perioperative BIA measurements may contribute to improved assessment of fluid balance and early identification of patients at increased risk of postoperative complications. The study is conducted at the Institute of Oncology Ljubljana in patients undergoing colorectal surgery for oncological indications.

Postoperative VR for Recovery After Bariatric Surgery

The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could improve postoperative recovery from bariatric surgery.

Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)

The goal of this clinical trial is to compare primary wound closure (PC) versus delayed primary closure (DPC) after standardized wound decontamination using the High-Efficiency Incision and Drainage with Irrigation (HIEDI) technique in patients undergoing open appendectomy for complicated appendicitis in Sana'a, Yemen. The main questions it aims to answer are: * Does primary closure with HIEDI result in a non-inferior or lower incidence of Surgical Site Infection (SSI) at 30 days compared with delayed primary closure with HIEDI? * Does primary closure with HIEDI reduce length of hospital stay and improve the trajectory of objective wound healing compared with delayed primary closure with HIEDI? * What is the impact of each closure method on patient satisfaction and health-related quality of life? Researchers will compare the two groups to determine the optimal, evidence-based standard of care for wound management in complicated appendicitis within a resource-limited setting. Participants will: * Undergo open appendectomy for intraoperatively confirmed complicated appendicitis (perforation or gangrene). * Receive standardized HIEDI wound decontamination (meticulous debridement and pulsatile irrigation with minimum 500 mL povidone-iodine 1:10 solution). * Be randomly allocated to either primary closure (all layers closed at surgery) or delayed primary closure (skin/subcutaneous tissue left open and closed 3-5 days later). * Attend follow-up visits at days 7, 14, and 30 for wound assessment, infection surveillance, and outcome evaluation.

POSSUM, P-POSSUM, Clinical Frailty Scale, Clinical Frailty Scale and Charlson's Comorbidity Index in Abdominal Surgery.

Abdominal surgery represents the most frequent activity in the surgical block. Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales. A prospective observational study will be carried out during 2021. All patients undergoing abdominal surgery will be included. Demographic variables, personal and surgical history, preoperative and intraoperative data, and variables related to surgery will be collected. At 30 days postoperatively, the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred. With these data, the POSSUM, the P-POSSUM, the Clinical Frailty Scale and the Charlson comorbidity index will be calculated.

P-POSSUM for Outcomes After Abdominal Surgery

Postoperative complications after abdominal surgery can lead to prolonged recovery, intensive care admission, and death. The P-POSSUM score is a commonly used surgical risk prediction tool, but its performance may vary between hospitals and patient populations. Frailty, especially in older patients, may also affect postoperative outcomes and may improve risk prediction when added to existing scoring systems. This ambispective observational cohort study evaluates the prognostic value of the P-POSSUM score, with additional assessment of frailty and routine perioperative clinical data, for predicting postoperative complications and treatment outcomes in adult patients undergoing abdominal surgery at Bach Mai Hospital. The study includes retrospective data from January 2025 and prospective data collection through May 2026. No intervention is assigned by the investigators. All patients receive routine perioperative care according to clinical practice. The study will assess the predictive performance of P-POSSUM for postoperative complications and mortality, and will explore whether adding frailty-related variables improves risk prediction.

Timing of Recruitment Maneuver in Robotic Prostate Surgery

Robotic prostate surgery is commonly performed under general anesthesia with carbon dioxide pneumoperitoneum and steep Trendelenburg positioning. These conditions may reduce lung volumes, impair respiratory mechanics, and increase the risk of atelectasis and postoperative pulmonary complications. Recruitment maneuvers combined with individualized positive end-expiratory pressure may improve intraoperative oxygenation and lung compliance; however, the optimal timing of recruitment maneuver application in robotic prostate surgery remains unclear. This prospective randomized study aims to compare the effects of recruitment maneuver timing on postoperative pulmonary complications in adult patients undergoing elective robotic prostate surgery. Participants will be randomized into two groups. In the Supine Recruitment Group, the recruitment maneuver will be performed before carbon dioxide insufflation while the patient is in the supine position, followed by individualized PEEP determination. In the Trendelenburg Recruitment Group, the recruitment maneuver will be performed after pneumoperitoneum and Trendelenburg positioning, followed by individualized PEEP determination. Patients will be evaluated for postoperative pulmonary complications up to postoperative 72 hours or until discharge, whichever occurs first.

Preoperative Fasting and the Gut Microbiome Before Hip Replacement

Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk. Preoperative therapeutic fasting has been shown to remodel the gut microbiome, lower proinflammatory cytokines, and improve metabolic parameters. This single-center, prospective, randomized, two-arm controlled trial at Charité - Universitätsmedizin Berlin investigates whether a structured 20-day preoperative fasting intervention (alternating cycles of the Buchinger Fastenbox and intermittent fasting) modulates two co-primary endpoints - plasma IL-8 (a central proinflammatory marker) and gut microbial alpha-diversity (Shannon index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-/B-/NK-cell subsets, activation/exhaustion markers, monocyte HLA-DR), microbiome composition and function, continuous glucose-monitoring and daily metabolic measures, patient-reported outcomes (HOOS, PROMIS-33, infection self-report), and clinical outcomes (postoperative complications per EBJIS criteria, length of stay). Adults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized metabolic-syndrome criteria) and randomized 1:1 to the fasting intervention versus standard care. Stool and whole-blood samples are collected at baseline (Day -21), and at Day +7 post-operatively for shotgun-metagenomic sequencing and multiparameter flow cytometry, with additional cytokine blood samples at Day -1 and 6 h / 24 h / 72 h post-operatively. Continuous glucose monitoring is performed in all participants from Day -21 until surgery. Planned enrollment is 130 participants.