Clinical Research Directory

Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery

Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.

A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. The clinical team is blinded to the leak detection of the xBar system.

Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery

This study will assess whether methylene blue fluorescence imaging can help surgeons identify the ureters during colorectal surgery. Methylene blue, given through a vein during the operation, is taken up and excreted by the kidneys, allowing the ureters to appear under a special fluorescence camera system. The study will include adults undergoing open, laparoscopic, or robotic colorectal surgery at Prince of Wales Hospital. The surgeons will compare ureter visibility using standard white light with visibility using fluorescence imaging at different stages of the operation. The study will also assess the best dose of methylene blue, the additional time required, the ease of using the imaging system, and whether the imaging findings affect the surgical plan. The study's hypothesis is that methylene blue fluorescence imaging will make it easier or faster to identify the ureters than white light alone. The technique will be considered feasible if it is helpful in at least 20% of operations-for example, by identifying a ureter earlier or identifying it when it cannot be seen under white light. The findings will help determine whether a larger future study should be conducted.

Randomised Controlled Trial of Fluorescent Urography Using Intravenous Methylene Blue Compared to White Light Alone in Left-sided Colorectal Surgery

This study will see if a blue dye (methylene blue) given into a vein, together with a special camera light, helps surgeons find the left ureter (the tube from the kidney to the bladder) faster during left-sided bowel surgery. Adults having open, laparoscopic, or robotic left-sided colorectal surgery will be randomly assigned to either the blue dye with special light or standard white light alone. The main question is whether the blue dye method finds the ureter more quickly, which could make the operation safer.

Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection

The study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication.The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.

Opioid-Free Anesthesia in Colorectal Surgery, 2025 (OFA-CRC-2025)

This study wants to find out if using a pain control method without opioids (Opioid-Free Anesthesia or OFA) works as well as or better than standard anesthesia (which uses opioids) for adults having minimally invasive (laparoscopic) colorectal surgery. Opioids are strong pain medicines often used during surgery, but they can cause side effects like nausea, vomiting, slower digestion, and breathing problems. Researchers will divide participants into two groups by chance (like flipping a coin). One group will receive the opioid-free anesthesia, which uses a combination of other types of pain medicines. The other group will receive standard anesthesia with opioids. The main goal is to see if the opioid-free method reduces pain and the need for extra pain medicine in the first 24 hours after surgery. The study will also look at whether patients have fewer side effects, wake up more comfortably, and can leave the hospital sooner.

Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy

The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)

Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery

Rationale: Anastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization. Among colon cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study identified a \>50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (OR: 5.9, 95% CI: 2.7-12.6, p \< .001). Primary objective: The ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \>50% stenosed SMA origin reduces the risk of AL following colon surgery. Secondary objectives: Classification of severity of AL, incidence of delayed AL (\>90 days), Mesenteric Artery Calcification Score (MACS), surgical complications, hospital (re)admissions, Quality of life (including health related quality of life), healthcare and societal costs, cost-effectiveness (expressed as incremental costs per quality-adjusted life year gained), and budget impact. Additionally, the added value of quantitative fluorescence angiography (qFA) in predicting AL during surgery, in hospitals with suitable equipment and experience, will be explored. This will enhance surgeons' capabilities in preventing AL. Study design: Nationwide multicentre randomized controlled trail with a 1:1 fashion Study population: Patients, 40 years and over, in the participating hospitals in the Netherlands with a \>50% SMA origin stenosis scheduled for elective colorectal resection with a primary anastomosis for malignant or benign colorectal pathology. Intervention: Intervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting of the SMA, within preferably two weeks prior to the colon resection. Control group will not undergo PTA and endovascular stenting of the \>50% SMA stenosis prior to the colon resection. Both groups will be treated with a mono antiplatelet therapy, i.e., carbasalate calcium (Ascal ®), for stent patency and atherosclerotic risk reduction. Intervention group has an indication for lifelong mono antiplatelet therapy and control group for at least 12 months Main study parameters/endpoints: The primary endpoint is the incidence of a clinically relevant AL within 90 days post-surgery. Secondary endpoints include AL classification/severity, calcification scores of aortic and mesenteric vessels, stenting complications, stent patency, intra-operative qFA measurements, operative duration, all causes of post-operative complications within 90 days, all reinterventions; surgical (including endovascular) and non-surgical within 90 days, duration of primary postoperative hospital stay and readmission within 12 months, 12 month mortality, patient-reported outcomes on month 0-3-6-12, cost-effectiveness budget impact analysis and stent patency. The total follow-up duration will be a total of 12 months.

The Value of Bowel Sounds in Evaluating Postoperative Intestinal Function Recovery in Colorectal Cancer Patients

This study enrolls patients scheduled to undergo curative surgery for colorectal cancer. Bowel sounds will be assessed preoperatively and postoperatively. By comparing intraoperative variables, the incidence of perioperative complications, reoperation rates, and postoperative outcomes-including time to first flatus, resumption of oral intake, and occurrence of intestinal obstruction-this study aims to investigate the association between perioperative bowel sounds and postoperative recovery, and provide evidence-based support for the clinical application of bowel sound monitoring. Supplementary Definitions

Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery

Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal surgery and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims: 1. The investigators will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery. 2. The investigators will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases. 3. The investigators will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery. 4. The investigators will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.

Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.

The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)

Mechanical Bowel Prep Randomized Study

Following colon surgery, surgical site infection (SSI) is the most common complication and leads to longer recovery time for patients and increased health care costs. Currently, there is high quality evidence to show that the combination of intravenous antibiotics (IVA), mechanical bowel preparation (MBP) and oral antibiotics (OA) is the most effective bowel preparation to reduce SSI. However, there are no studies comparing IVA+MBP+OA and IVA+OA. This is an important question because if IVA+OA works the same as IVA+MBP+OA, then MBP may be safely omitted as part of the bowel preparation to reduce SSI and patients would avoid the side effects of MBP prior to their surgery. Therefore, the objective is to perform a trial to determine if IVA+OA works the same as IVA+MBP+OA to reduce SSI following colon surgery.

Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation

To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F \& 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation. A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.

The Impact of AI-Assisted Nursing Care Intervention Within the Enhanced Recovery Framework on Outcomes of Colorectal Surgery Patients

Colorectal cancer is one of the most common cancers worldwide, affecting a large number of people each year (Bray et al., 2022). Surgical intervention remains the gold standard in treatment. However, advances in surgical techniques and increased effectiveness of neoadjuvant therapies have brought sphincter-preserving surgeries to the forefront, reducing the need for stoma creation compared to the past (Jo \& Wilson, 2025; Wang et al., 2025). Even without stoma creation, these patients face complex care needs in the post-discharge period, including changes in bowel habits, nutritional management, and adaptation to physical activity (Wang et al., 2025). Difficult-to-manage complications carry a high risk of readmission to the hospital. Patients receive limited support during the transition from the hospital to home and at home (Storm et al., 2024). Patients and their families are often left alone to manage home care until routine follow-up appointments. Patients, especially those poorly prepared for discharge, may not know how to perform care practices at home or what to watch out for in case of complications. Situations that are well managed in the hospital can spiral out of control upon inadequate follow-up after the patient returns home, leading to unplanned readmissions. Insufficient postoperative patient follow-up can cause anxiety in patients, leading to readmissions due to the inability to manage the home care process effectively (Storm et al., 2024). Although accelerated recovery after surgery (ERAS) is known to shorten hospital stays (Gustafsson et al., 2025; Gustafsson et al., 2019), studies show varying results regarding readmissions, re-operations, developing complications, and survival (Coleman et al., 2006; Takchi et al., 2020; Lee et al., 2022). These variable results highlight the need for a structured discharge process and home care management for patients who undergo ERAS and are discharged home earlier. In the study by Takchi et al. (2020), a scheduled phone call was proposed as the final step in advanced recovery recommendations and presented as a pilot study. The study reported that each patient contacted reported at least one symptom and personal care need (Takchi et al., 2020). The scheduled phone calls proposed by Takchi et al. (2020) are an important monitoring mechanism in the recovery process; however, they are insufficient. Supporting this monitoring process with a structured discharge management and AI-powered digital video accessible to the patient at any time, extends the continuity of care to a digital dimension. It is reported that AI-powered multimedia tools, whose use is increasing with the transformation in health technologies today, reduce cognitive load by concretizing complex surgical processes with audiovisual materials and improve patients' self-care skills regardless of their health literacy level (Mendoza-Pinto et al., 2025). "Content prepared with generative artificial intelligence algorithms, in particular, increases the retention of information and the patient's digital health literacy compared to traditional educational materials (Zaretsky et al., 2024). This study aims to both structure the discharge and post-discharge follow-up process, which is included in ERAS protocols to a limited extent, and to increase the patient's readiness for discharge, improve patient outcomes, and facilitate home care management using AI-assisted educational videos. Thus, the study significantly points to a fourth step, which is included in ERAS guidelines in the pre-operative, intra-operative, and post-operative phases and is felt to be missing: the discharge and home follow-up process.

VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery

Introduction: Anastomotic leakage (AL) is the most severe complication following colorectal surgery and is associated with significant morbidity and mortality. VacStent therapy is a promising therapeutic approach, combining endoscopic vacuum therapy with mechanical stability of a stent and thereby allowing continued fecal passage. It may enhance anastomotic healing and reduce the need for a diverting ostomy or additional surgical procedures. VACStent Use for the treatment of anastomotic leakage following coloREctal surgery (VACURE) study aims to assess the efficacy and safety of VacStent therapy for colorectal AL. Methods and analysis: VACURE is a prospective, multicenter efficacy study conducted at ten Dutch hospitals. Forty patients will be included over 18 months. All patients (≥18 years) with AL of the distal sigmoid, upper or mid rectum following colorectal resection will be considered for treatment with the VacStent GI Colon device. Trained endoscopists will perform stent placement, exchanges, and removal. Patients will remain hospitalized and those without diverting ostomy will receive osmotic laxatives and a fiber-free diet during treatment. Anastomotic healing will be confirmed endoscopically and radiologically posttreatment. The primary endpoint is the primary endpoint is the rate of participants that achieve complete anastomotic healing without the need for further interventions (confirmed by radiologic and endoscopic assessment). Secondary endpoints include safety, percentage of functioning anastomoses at 1 year post-treatment, 1-year stoma-free survival, diverting ostomy omission, healing time, number of stents, complications, reinterventions, length of hospitalization, pain scores, functional and quality of life outcomes up to 1 year posttreatment, patient experiences, and cost-effectiveness.

Bilateral Erector Spinae Plane Block Versus Bilateral Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Colorectal Surgery

This study aims to compare the ultrasound-guided bilateral erector spinae plane block (ESPB) and oblique subcostal transverse abdominal plane block (OSTAPB) for postoperative analgesia in colorectal surgery.

Early vs Standard Ileostomy Reversal

This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes.

Nutritional Supplementation to Improve Colorectal Cancer Surgery

This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.

Optimizing Care Transition Process for Older Colorectal Surgery Patients

The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.

The Hugo RAS Colorectal Collaborative

The Hugo RAS Colorectal Collaborative (HRCC) is an international, multicenter dataset of patients undergoing colorectal surgery using the Hugo RAS system. The registry aims to analyze short and long-term outcomes to provide real-world evidence on the safety and effectiveness of the system.

Efficacy and Safety of Colorectal Anastomotic Leak Testing

To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery

Pre-Surgical Immunonutrition's Effect on Colorectal Surgery

Colorectal surgery patients face excessive catabolism, increasing inflammation and immune compromise. The administration of nutritional supplements known as immunonutrition before gastrointestinal surgery has been shown to improve clinical outcomes; however, the mechanisms underlying these benefits remain inconclusive. The objective of the study is to evaluate the effect of preoperative nutritional supplementation with an immunonutrient-enriched formula compared to an isocaloric and isoproteic formula on plasma BCAA concentration in patients undergoing elective colorectal surgery. A double-blind, randomized controlled clinical trial will be conducted. Patients will be required to drink the supplement daily for the 7 days preceding the surgical intervention. Patients in both groups will be instructed to maintain their usual food intake. During the study, there will be two patient assessments and a review of medical records to document the outcomes.

Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)

The goal of this Clinical Investigation is to evaluate the effectiveness of implementing the discharge protocol of the remote monitoring platform after colorectal surgery in patients at risk of hospital readmission. Participants will be randomized into either the "30 days of remote monitoring" group or the "conventional discharge" group. The patient returns to the site for their postoperative visit at 30 days and is contacted by phone 90 days after their surgery.

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic. Digestive surgeons use a variety of pre-, per- and post-operative techniques to reduce the rate of anastomotic fistula, but the risk persists, with a rate of 7% reported in the literature. It has been shown that the value of CRP between D1 and D5 correlates with the risk of AL, and that the trajectory between two consecutive days (D1 to D5 post-op) is the most discriminating element in predicting the risk of AF. This assay requires repeated intravenous sampling, which is the opposite of simplifying care. CRP point-of-care testing (POCT) is used in clinical practice, notably in pediatrics and outpatient medicine (in children and adults) to help prescribe probabilistic antibiotic therapy, as the instantaneousness of the result has an impact on patient management. For the diagnosis of AL, CRP POCT assessment could reduce the number of blood samples taken, shorten the time between sampling and medical management in cases of suspected AL, and thus improve the patient's post-operative experience.