Clinical Research Directory

Virtual Reality for Postoperative Recovery After Major Abdominal Surgery

Major abdominal surgery often leads to significant postoperative pain, anxiety, and prolonged hospital stays, which can delay overall recovery. This study aims to evaluate the effectiveness of immersive Virtual Reality (VR) as a non-pharmacological intervention to enhance the quality of recovery and reduce the length of hospital stay. Patients in the intervention group will engage in standardized VR sessions featuring guided relaxation and mindfulness-based stress reduction, starting from the evening before surgery through the third postoperative day. The study compares this VR-enhanced protocol against standard perioperative care within an Enhanced Recovery After Surgery (ERAS) framework. The findings are expected to determine if VR can serve as a feasible and effective tool to improve clinical outcomes and patient well-being in surgical wards.

Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.

This is a bicentric, prospective, non-pharmacological, randomized study designed to compare the efficacy and safety of awake neuraxial anesthesia with sedation versus general anesthesia in frail patients undergoing elective major laparoscopic or robotic abdominopelvic surgery. A total of 100 frail patients aged over 60 years, with ASA physical status \>2 and evidence of frailty and/or cognitive vulnerability, will be randomized to receive either standard general anesthesia with mechanical ventilation or thoracic neuraxial anesthesia combined with non-GABAergic sedation while maintaining spontaneous breathing. The primary objective is to evaluate the feasibility in terms of recruitment of a RCT conducted in a population of frail or cognitively impaired patients undergoing major laparoscopic abdominal surgery, randomized to a neuraxial or general anesthetic approach in which the effects on the onset of postoperative delirium and postoperative cognitive dysfunction (POCD) will be determined. Secondary outcomes include the occurrence of postoperative organ dysfunction (respiratory, cardiovascular, renal, and metabolic), length of hospital stay, time to recovery after surgery, and postoperative mortality. Patients will undergo comprehensive perioperative clinical, laboratory, and ultrasound assessments, including lung and renal ultrasound evaluations. Neurological and functional status will be assessed during hospitalization, at 1 month, and via telephone follow-up at 1 year after surgery. The aim of the study is to evaluate the feasibility and safety of performing two different anesthetic techniques on fragile patients.

Analysis of the Composition of the Intestinal Microbiota in Patients Post-intestinal Anastomosis

Recent research suggests a significant link between gut microbiota and anastomotic leakage (AL) in colorectal surgery. Patients who develop AL have a higher abundance of bacteria from the Lachnospiraceae family and lower microbial diversity. Considering the bibliographic data, our main interest is to analyze the microbial population of patients in our social environment and then look for differences in the microbiome between those who have suffered an anastomotic dehiscence (around 8-9% according to the results of our hospital's Surgery Department) and those who have not.

Dalargin for Prevention of Organ Disfunction in High-Risk Abdominal Surgery

Major abdominal surgeries (e.g., gastrectomy, pancreatectomy, colectomy) carry a high risk of life-threatening postoperative complications, including multiorgan disfunction syndrome (MODS), acute kidney injur (AKI), miocardial injury after non-cardiac surgery (MINS) and severe infections. These complications are driven by ischemia-reperfusion injury, leading to oxidative stress and a systemic inflammatory response. Despite advances in surgical and anesthetic techniques, there are no effective pharmacological strategies for personalized prevention of these events, which adversely affect recovery and survival. In this context, opioid receptor agonist, particularly senthetic analogs of Leu-enkephalin such as Dalargin, have emerged as promising agents for pharmacologica preconditioning. Preclinical evidence suggests their ability to mitigate oxidative stress and inflammation by moduating key signaling pathways . The potential for these peptides to protect andothelial function and reduce organ damage presents a novel therapeutic avenue. This study aims to clinically test the hypothesis that perioperative intravenous infusion of Dalargin reduce the incidence and severity of postoperative organ dysfunction. Patients undergoing high-risk abdominal surgery will be randomized to receive either a 72-hour continuous of Dalargin (following a defined dosage regimen) or an identical placebo infusion. the study will also integrate an assessment of genetic polymorphism ( e.g., in NRF2, OLR1, TLR9 genes) to explore personalized approaches to risk stratification and prevention.

Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

The aim of the planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Furthermore, this trial aims to provide preliminary data on the clinical outcome of such assistance systems.

Effect of Preoperative Abdominal Effleurage on Postoperative Constipation

This randomized controlled study aims to evaluate the effect of preoperative abdominal superficial effleurage training on the development of postoperative constipation in patients undergoing abdominal surgery. Participants will be randomly assigned to an intervention group receiving abdominal superficial effleurage training in addition to routine care or to a control group receiving routine care only. The effleurage technique will be taught preoperatively and performed by patients postoperatively. Postoperative constipation will be assessed on the 10th postoperative day using the Bristol Stool Form Scale. The findings of this study are expected to contribute to non-pharmacological nursing interventions for the prevention of postoperative constipation.

External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery

Postoperative pain after laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery) is often severe, and inadequate analgesia may lead to increased opioid use, opioid dependence, and poor functional recovery. Current analgesic techniques such as neuraxial block have safety concerns (e.g., hypotension, neurological injury), while transversus abdominis plane (TAP) block is ineffective for blocking the lateral cutaneous branches of intercostal nerves in the upper abdomen. The External Oblique Intercostal Plane Block (EOIB) is a novel regional block technique that has shown promise in reducing postoperative opioids and pain in small-scale studies, but evidence for its use in major upper abdominal surgery is limited. This randomized controlled trial (RCT) aims to evaluate the analgesic efficacy and safety of bilateral EOIB combined with standard multimodal analgesia versus standard multimodal analgesia alone in patients undergoing elective laparoscopic major upper abdominal surgery. The primary outcome is the total postoperative opioid consumption (measured as Morphine Milligram Equivalents, MME) within 24 hours. Secondary and additional outcomes include pain scores (Verbal Rating Scale, VRS), recovery quality (QoR-15 scale), incidence of adverse events, and hospital stay.

Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure

This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.

Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery

Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk. In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery.

Pip Care to Improve Surgical Patient Outcomes

Pip Care is developing a personalized, interactive surgical journey platform with a live health coach that works directly with health systems to optimize the perioperative care process. Our Health Insurance Portability and Accountability Act (HIPAA)-compliant platform, Pip, can be integrated into any electronic medical record (EMR), thus alleviating the administrative burden by making operational workflows more efficient. The PIP empowers patients and their families to be more involved in their care by breaking down a patient's healthcare plan into definable, easy-to-understand, and easy-to-complete tasks. Additionally, a health coach completes a health intake to create a personalized perioperative care plan, meets regularly with the patient to encourage goal accomplishment, and facilitates care coordination. This project has 2 phases; Phase I is to assess usability of the Pip Care platform in surgical patients, Phase II is a RCT (Randomized Controlled Trial) to assess surgical clinical outcomes while using Pip compared to standard of care.

Therapeutic Effects of Pranayama Breathing Technique and Deep Breathing Exercises on Pain and Anxiety After Abdominal Surgery

This study will be conducted to evaluate the therapeutic effects of pranayama breathing technique and deep breathing exercises on pain and anxiety after abdominal surgery.

Development of a Patient-Reported Outcome Measure to Assess Recovery After Abdominal Surgery

As surgery enters the era of value-based care, it is advocated that postoperative recovery be measured using patient-reported outcomes (PROs) as they provide a mean to incorporate the patient's perspectives and experiences into research and clinical decision-making. In abdominal surgery, this is currently precluded by the lack of PRO measures specifically developed and validated in the context of postoperative recovery. The core goal of this research project is to develop a PRO measure aimed to assess postoperative recovery from the perspective of patients undergoing abdominal surgery. This project complies with the US Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for PRO development and will be conducted in three phases: Phase 1: Qualitative interviews with patients to develop a conceptual framework and generate relevant items. Phase 2: Use of Rasch Analysis for item-reduction and scale formation. Phase 3: Further assessment of measurement properties based on traditional psychometric methods.

Effect of Hot Pack Application on Gastrointestinal Motility After Abdominal Surgery

Study Title: The Effect of Hot Water Pack Application to the Lumbar Region on Gastrointestinal Motility in Postoperative Abdominal Surgery Patients Study Type: Interventional (Randomized Controlled Trial) Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Outcome Assessor) Primary Purpose: Supportive Care Condition: Postoperative Gastrointestinal Motility in Abdominal Surgery Patients Interventions: Experimental: Hot Water Pack Application Intervention: Application of a hot water pack (heated to 40-42°C) to the lumbar region for 20 minutes, three times a day, in the first 48 postoperative hours. Purpose: To evaluate its effect on gastrointestinal motility and postoperative recovery. Control: Routine Care Intervention: Standard postoperative care without hot water pack application. Primary Outcome Measures: Time to First Postoperative Gas (Hours) \[Time Frame: Up to 72 hours\] Time to First Postoperative Stool (Hours) \[Time Frame: Up to 72 hours\] Time to Initiation of Oral Intake (Hours) \[Time Frame: Up to 72 hours\] Secondary Outcome Measures: Incidence of Postoperative Nausea and Vomiting (PONV) \[Time Frame: Up to 72 hours\] Severity of Abdominal Distension \[Time Frame: Up to 72 hours\] Quality of Recovery-15 (QoR-15) Scale Score \[Time Frame: Postoperative Days 1 and 3\] Gastrointestinal Symptom Rating Scale (GSRS) Score \[Time Frame: Postoperative Days 1 and 3\] Eligibility Criteria: Inclusion Criteria: Abdominal surgery in the general surgery ward Age ≥ 18 years BMI between 18.50-24.99 kg/m² Able to communicate verbally Conscious, oriented, and willing to participate Exclusion Criteria: Previous gastrointestinal surgery Postoperative complications History of small bowel resection, ileostomy, or colostomy History of inflammatory bowel disease, emergency surgery, neoadjuvant therapy, appendectomy Chronic opioid use Chronic constipation (≤ 2 bowel movements per week) Abdominal radiotherapy ICU admission or postoperative bleeding Estimated Enrollment: 80 participants (40 intervention, 40 control)

Mobilisation and Breathing Exercises After Abdominal Surgery at Sahlgrenska University Hospital

The aim of the study is to evaluate the effect of a new care strategy, including earlier and more intensive mobilization and individually adapted breathing exercises, regarding length of stay, recovery, complications and which factors predict interventions early in the postoperative course after various abdominal surgical procedures.

Virtual Reality Glasses and Stress Ball Applications in Dressing Change

According to the statistical data of the Ministry of Health for the year 2021 in Türkiye, approximately 4.7 million surgical interventions are performed annually. According to the 2017 data from the National Health Service-Associated Infections Surveillance Network, the Surgical Site Infection (SSI) rate in our country is 0.72%, and it is stated that it can be prevented by approximately 60%. Dressing application holds an important place in surgical wound management, wound healing, and preventing complications. Patients may experience pain, anxiety, and fear due to unknown factors and previous experiences during the dressing change which holds an important place in wound care management. The aim is to minimize patients\' negative emotions/situations during dressing changes by diverting their attention elsewhere using virtual reality (VR) glasses and stress balls. Upon reviewing the literature, no study was found that examines the effect of applying VR glasses and stress balls during abdominal surgery dressing changes on pain, vital signs, anxiety, fear, comfort, and satisfaction levels in adults. In this regard, the aim of the research is; to examine the effects of VR glasses and stress ball application on pain, vital signs, anxiety, fear, comfort, and satisfaction levels during dressing changes in patients undergoing abdominal surgery. The study was designed as a pre-test post-test control group randomized experimental model. The sample of the study consists of adult patients who underwent abdominal surgery in Isparta City Hospital General Surgery Service-1. In the study sample, 120 individuals were included in total 40 with VR glasses, 40 individuals using stress balls, and 40 in the control group. Patient Information Form, Visual Analog Scale, and State-Trait Anxiety Scale will be used in data collection. Data from the study will be analyzed with number, percent, average, x-square, variance, and t-test in a computer environment. In consideration of the data, it is believed that important findings will be obtained in increasing satisfaction and comfort by eliminating pain, anxiety, and fear during dressing changes in patients.

Impact of NOL Index Intraoperative Guided Remifentanil Analgesia

The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP). The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients. The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.

Effects of ACBT and Blow Bottle Technique in Patients With Abdominal Surgeries Under General Anesthesia

A postoperative pulmonary complication (PPC) is the most common serious complication after Abdominal surgery under GA which lead to longer hospital stays and have deleterious outcomes on lung volumes, mucociliary clearance, accumulation of mucus, saliva and cough reflex. Chest physiotherapy for airway clearance which includes postural drainage, chest percussion, vibrations, Along with these, breathing exercises such ACBT and Blow bottle technique are recommended to clear secretion which aid in enhancing pulmonary function by effectively mobilizing and eliminating excess bronchial secretions. This study of randomized clinical trial will check the comparative effect of ACBT and Blow Bottle Technique in patients with abdominal surgeries under GA by taking a sample of 44 patients through non probability convenience sampling technique. Subject of both gender will be included between the age of 30 to 50 years who will undergoes with elective abdominal surgeries under GA (Cholecystectomy, Hysterectomy ,Appendectomy, Hemorrhoidectomy) and Laparoscopic /open. Elective surgeries under spinal anesthesia, emergency surgeries, cardiothoracic surgeries and hemodynamically unstable subjects will be excluded. 22 subjects will receive ACBT and other 22 subjects will receive Blow bottle technique for 20 minutes duration per session, two sessions per day for a period of 5 days. The status of airway clearance, oxygen saturation and lungs volumes will be measured pre and post intervention on day 1 and at the end of 5th day by using BCSS, Pulse oximeter and Spirometer.