Clinical Research Directory

Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study

The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.

Lung Mechanics and Ventilation Efficiency in Robotic Surgery

Robotic surgery requires pneumoperitoneum and specific surgical positioning such as steep Trendelenburg, reverse Trendelenburg, or supine positioning. These intraoperative conditions may lead to cranial displacement of the diaphragm, reduced lung compliance, and increased airway pressures, potentially impairing respiratory mechanics and gas exchange. Previous studies have primarily evaluated respiratory mechanics during robotic surgery at single time points or within specific surgical procedures. However, dynamic changes occurring during critical phases of robotic surgery have rarely been evaluated prospectively. This prospective observational cohort study aims to evaluate phase-specific changes in lung mechanics and ventilation efficiency during robotic surgery. Key parameters including mechanical power (MP), ventilation efficiency index (VEI), static compliance, and driving pressure will be analyzed across predefined intraoperative phases.

Cardiac Performance During Steep Trendelenburg Position in Patients Undergoing Robotic Surgery Surgery.

The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent. The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions. In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery.

A Prospective Single-center Randomized Controlled Trial of Robotic Surgery With Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon Cancer

This study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer. At the same time, the safety and advantages of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer were compared.

Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction

Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques. Its use has expanded in both therapeutic and risk-reducing settings, including ductal carcinoma in situ (DCIS) and early-stage invasive breast cancer, where the NAC is not clinically or radiologically involved. Multiple observational and cohort studies support the oncological safety of NSM in appropriately selected patients, provided meticulous surgical technique and pathological assessment are employed to minimise the risk of residual disease. Robotic-assisted NSM has emerged as a minimally invasive alternative to conventional open techniques. Robotic platforms offer enhanced three-dimensional visualisation, improved instrument articulation, and ergonomic advantages that may facilitate precise dissection while reducing surgeon fatigue. Single-port robotic systems enable NSM to be performed through a single axillary incision, potentially reducing visible scarring and postoperative discomfort while maintaining oncological principles. Early series from high-volume centres have demonstrated the technical feasibility and short-term safety of robotic NSM, with outcomes broadly comparable to open NSM and signals of potential aesthetic benefit. However, these data are largely non-randomised and derived from single-centre experiences. Despite the increasing adoption of both conventional and robotic NSM, there remains a paucity of high-quality prospective evidence evaluating patient-reported outcomes (PROs). Validated instruments such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS) provide robust measures of patient satisfaction, psychosocial well-being, and aesthetic outcome, yet randomised comparisons of robotic versus open NSM using these tools are lacking. In particular, there is limited evidence examining whether the proposed cosmetic and experiential advantages of robotic surgery translate into meaningful improvements in PROs across different reconstructive pathways. Breast reconstruction is a critical determinant of postoperative quality of life following mastectomy. Both implant-based reconstruction and autologous reconstruction using deep inferior epigastric perforator (DIEP) flaps are established techniques, each with distinct risk profiles, recovery trajectories, and long-term outcomes. Autologous DIEP reconstruction is associated with superior long-term satisfaction and physical well-being in many patients, while implant-based reconstruction remains the most commonly performed approach nationally. Evaluating NSM techniques across both reconstructive modalities enhances the generalisability and clinical relevance of trial findings. The REBORN Network Trial is a multicentre, randomised controlled study conducted within an Irish cancer network using a hub-and-spoke model for robotic surgery delivery. Patients undergoing mastectomy with immediate reconstruction are stratified by reconstruction type (implant-based or DIEP flap) and randomised to receive either robotic-assisted or conventional open NSM. Robotic procedures are centralised within a designated surgical hub, while open procedures are delivered either locally or centrally, depending on reconstructive requirements. This design enables equitable access to robotic surgery while maintaining oncological safety and surgical expertise. By comparing robotic-assisted and open NSM within both implant and DIEP reconstruction cohorts using validated PRO measures, this study aims to determine whether robotic technology confers measurable benefits in patient satisfaction, body image, and aesthetic outcome. The findings will inform patient counselling, surgical decision-making, and future service development within networked breast cancer care systems.

Public Perceptions Toward Robotic Surgery, Telesurgery and Telemedicine

This study aims to systematically assess the public's and clinicians' levels of awareness, attitudes, risk perception, acceptance, and potential concerns regarding robotic surgery and telesurgery. It also analyzes the key factors influencing their attitudes and explores the needs of physicians regarding training systems for robotic and telesurgery, as well as the factors affecting their preparedness.

Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast. However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries. This study will compare: * Robotic nipple-sparing mastectomy * Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients. Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.

Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial

Endotracheal intubation is a respiratory management technique used during general anesthesia. It is essential for certain surgical procedures as it ensures a secure airway for the patient. However, during the placement of the endotracheal tube, the passage of the tube through the vocal cords can cause pain stimulation, leading to an increase in heart rate and blood pressure. Lidocaine reversibly blocks the conduction of nerve impulses along nerve fibers by preventing the movement of sodium ions across the nerve membrane. Topical application of lidocaine near the vocal cords before endotracheal tube placement may be a way to reduce the surgical pleth index and changes in vital signs (heart rate, blood pressure) caused by excessive endotracheal tube stimulation. This study aims to investigate the benefit of topical spraying of lidocaine on the vocal cords before endotracheal tube placement during routine da Vinci surgery. The primary outcomes were the pharmacological effects of spraying either lidocaine or normal saline (control group) on the vocal cords. These included: post-intubation hypertension (defined as an increase in systolic blood pressure of more than 20% from baseline), changes in mean arterial pressure before and after intubation, and objective pain indices such as the Surgical Pleth Index. Secondary outcomes included post-intubation hypotension (defined as mean arterial pressure less than 70 mmHg), as well as postoperative complaints and severity of sore throat, pain on swallowing, and hoarseness.

The Effect of Dexmedetomidine on Postoperative Cognitive Function in Geriatric Patients

In pelvic surgeries, using laparoscopic surgical procedures provides advantages such as reduced postoperative pain and complications, early mobilization, shorter hospital stays, lower costs, better cosmetic outcomes, and faster return to daily activities. In robotic surgeries, the instruments have superior maneuverability compared to the human wrist, allowing for more precise work in delicate areas with a three-dimensional view while eliminating the surgeon's hand tremor. On the other hand, despite advances in surgical techniques, anesthesia management, and intensive care, a significant proportion of geriatric patients experience cognitive decline after surgery. Postoperative cognitive function decline can reduce the quality of life and lead to significant damage to family and social support systems. Postoperative cognitive dysfunction (POCD), defined as a decline in cognitive function following surgeries performed under general anesthesia, is a common postoperative cognitive impairment, particularly in the elderly population. Studies have shown that the incidence of POCD in individuals aged 60 and above ranges between 20% and 40%. Additionally, POCD is associated with prolonged hospital stays, reduced mobility, and increased mortality. Patients undergoing robotic laparoscopic radical surgery assume the Trendelenburg position, which provides better exposure of the pelvic organs. However, in robotic-assisted laparoscopic surgeries, patients must be placed in a steep Trendelenburg position. Prolonged pneumoperitoneum and excessive head-down tilt can increase the permeability of the blood-brain barrier. As a result of the Trendelenburg position, intracranial pressure may increase, leading to brain hypoxia, inadequate cerebral blood flow, low arterial oxygen content, anemia, and high brain oxygen consumption. Impaired cerebral oxygenation can directly affect brain function. Compared to conventional laparoscopic surgery, patients undergoing robotic-assisted laparoscopic surgery tend to exhibit prolonged emergence from anesthesia and increased psychomotor agitation due to factors such as stress response, trauma, anesthesia, bleeding, and transfusion. This condition is influenced by factors such as decreased cerebral blood flow and hypotension. Therefore, real-time monitoring methods are needed to detect and address cerebral hypoxia. While diagnostic tools like computed tomography (CT), echocardiography (ECHO), electroencephalography (EEG), and magnetic resonance imaging (MRI) reveal brain damage at a later stage, near-infrared spectroscopy (NIRS) is a continuous, safe, and non-invasive method for detecting cerebral hypoxia. Identifying oxygen deficiency in the brain can allow adjustments in treatment strategies and help prevent postoperative cognitive dysfunction, potentially reducing patients' intensive care and hospital stay durations while minimizing complications. Recently, certain medications have been used to prevent postoperative cognitive dysfunction. Dexmedetomidine, a drug with neuroprotective properties, is commonly used perioperatively in patients undergoing surgery under general anesthesia. Pharmacologically, dexmedetomidine is an α2-adrenergic agonist with sedative, analgesic, anxiolytic, and diuretic effects. However, previous clinical studies evaluating the effects of dexmedetomidine on POCD in elderly patients have yielded inconsistent results. This study aims to investigate the effects of dexmedetomidine on recovery from anesthesia and postoperative cognitive function in elderly patients undergoing robotic urologic surgery, particularly focusing on its neuroprotective properties. Patients included in our study will be randomly divided into two groups. Both groups will undergo routine standard ASA monitoring, NIRS, and BIS monitoring. Both groups will receive standard anesthesia induction. Then, one group will receive sevoflurane + remifentanil, while the other group will receive dexmedetomidine and remifentanil infusion along with sevoflurane. Both patient groups will undergo the Mini-Mental State Examination (MMSE) before and after the operation. During the intraoperative period, anesthesia depth will be monitored using BIS (maintaining the depth between 40 and 60 for both groups), and oxygenation will be tracked using NIRS. Our study will include geriatric patients undergoing robotic urologic surgery. The patients will be randomly divided into two groups. The randomization process will be performed using a web-based randomization program (Sortition), which is defined for validity. The anesthesiologist providing anesthesia management and the anesthetist conducting the postoperative cognitive function monitoring will be different individuals. Patients who accept the study and undergo the preoperative Mini-Mental Test will be included in the study after postoperative assessments on the 24th hour and the 7th day.

Robotic Curriculum for Young Surgeons

Robotic training program for unexperienced novice surgeons

Robotic Versus Laparoscopic Sleeve Gastrectomy

Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time. Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.

Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction

Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation. Patients need to accept the double blow of physical and psychological loss of breast shape. Although with the change of the concept of early diagnosis and treatment of breast cancer, the breast conserving rate of breast cancer is gradually increasing in China, more than half of the patients are still unable to retain breast due to their condition. For these patients, breast reconstruction surgery is an important means to improve the postoperative breast shape. With the improvement of surgical technology, endoscopic/robotic NSM combined with immediate prosthesis breast reconstruction has been gradually developed. According to previous literature reports, it has good tumor safety and aesthetics, but it is still lack of large-scale prospective results. This project plans to adopt a prospective cohort design, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and prospectively include patients who receive NSM combined with immediate prosthesis reconstruction under endoscopy/robot and conventional surgery from January 1, 2025 to December 31, 2028. The perioperative complications, tumor safety and patient reported outcomes of the two methods were compared.

Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)

Even after the wide introduction of chemo/radiotherapy in the treatment algorithm, adequate surgery remains the cornerstone of gastric cancer treatment with curative intent. A proper D2 lymphadenectomy is associated with improved cancer specific survival as confirmed in Western countries by fifteen-year follow-up results of Dutch and Italian randomized trials. In clinical practice, the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy; nonetheless, the number of retrieved nodes does not necessarily correlate with residual nodes, which intuitively could represent a more reliable marker of surgical adequacy. The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes. The goal of this multicentric observational prospective study is to test the reliability of a new score (PhotoNodes Score) created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer. The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopic/robotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection. Ideally, this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer.

Effectiveness of Robotic Surgery for Right Colon Cancer

This study aims to explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis.