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.

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.

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.

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.

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.

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.

Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)

Effective postoperative pain management is essential for enhanced recovery after laparoscopic colorectal surgery. This randomized, controlled, double-blind trial will compare conventional postoperative analgesia (intravenous medications plus surgical wound infiltration) with a locoregional strategy combining a peripheral autonomic block (inferior mesenteric and superior hypogastric plexuses) and a transversus abdominis plane (TAP) block. We hypothesize that the combined strategy (BAPTAP) reduces pain intensity and opioid consumption in the first 48 hours after Left-Sided Colorectal Resection.

Duration of Urinary Catheterization

This study is being conducted to determine the length of time a urinary catheter is needed to drain urine from the bladder after colorectal surgery. Urinary retention is a well known complication after pelvic colorectal surgery, and current practice is to continue urinary catheterization for 3- days following pelvic colorectal surgery in an effort to avoid this complication. However, prolonged urinary catheterization is associated with increased risk of urinary tract infections as well as longer hospital stays. The investigators hypothesize that postoperative urinary catheters may be safely removed on postoperative day 1 without increased urinary retention rates. The purpose of this study is to evaluate whether a shorter duration of urinary catheterization (1 day) is non-inferior when compared to standard duration (3 days) in regards to postoperative urinary retention. The investigators plan to perform a prospective, randomized, non-inferiority trial comparing the urinary catheter duration of 1 day and 3 days with the primary endpoint of postoperative urinary retention. Secondary endpoints are urinary tract infection and length of hospital stay. The participants will be randomly assigned to the control group (catheter removal on postoperative day 3) or the experimental group (catheter removal on postoperative day 1).

Nurse-Led Early Mobilization After Colorectal Surgery

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

Study of Postoperative Ileus in Digestive Surgery

Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of resumption of transit can lead to the implementation of specific treatments such as the placement of a nasogastric tube and drug treatments. To date, the definition of this event is not accepted by everyone and is not based on reproducible evaluation criteria. The main objective of this study is to evaluate a score used to date to define postoperative ileus, the IFEED score, and to compare it to the length of postoperative stay.

The Effect of Virtual Reality Glasses Application on Pain and Anxiety Levels in Colorectal Surgery Patients

This study aims to determine the effect of virtual reality glasses on pain and anxiety levels in colorectal surgery patients. This study is a single-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted with 60 patients who underwent colorectal surgery between August 2025 and December 2025. Participants will be randomized into two groups as the intervention group (n=30) and the control group (n=30). All patients in the experimental and control groups will be asked to fill out the "Informed Consent Form" the day before the surgery, and the patients who agree to participate in the study will be asked to fill out the "Patient Introduction Form" and the "State Anxiety Scale" by the researchers. The "Simulator Illness Questionnaire" used in the Virtual Reality disease field will be applied to the experimental group to determine their physiological conditions before the application. Then, a relaxing music-backgrounded video containing images of nature will be watched with virtual reality glasses for 10-15 minutes the day before the surgery. Then, the "Simulator Illness Questionnaire" and the "State Anxiety Scale" will be filled out again. The "Simulator Illness Questionnaire" will be applied to the patients 2 hours after their transfer from the postoperative care unit to the clinic, which is the most appropriate time after the surgery, when their vital signs have stabilized and clinical compliance has been achieved, and their physiological conditions before the application will be determined. Then, the patients in the experimental group will be asked to watch a relaxing music-backgrounded video containing images of nature for 10-15 minutes with virtual reality glasses. The researcher will perform the video with virtual reality glasses in the patient rooms and beds. Afterwards, the "Simulator Disease Survey" will be repeated. There will be no compelling effect that will negatively affect the health of the patients during the application, and the application will be terminated when the patients feel uncomfortable. A safe environment will be created so that there are no objects around the patients that they can bump into or trip over. A 5-10 minute trial period will be performed at the beginning with the observer and the virtual reality glasses will be applied. The patient will be able to end the study at any time. If the patients use glasses/lenses, compliance will be checked. No intervention will be applied to the control group patients and the routine practices of the clinic will continue. All patients in the experimental and control groups will be assessed for pain with the Visual Analog Scale (VAS) at the 2nd and 4th hours and the "State Anxiety Scale" will be applied.

Diverting Ileostomy and Transverse Colostomy Comparative Study

Protective diverting stomas are frequently constructed after low anterior resection or colorectal anastomosis to mitigate the consequences of anastomotic leakage, one of the most feared complications in colorectal surgery. Both loop ileostomy (LI) and loop transverse colostomy (TC) are accepted methods of diversion. Randomized and observational studies have shown that faecal diversion significantly reduces the clinical severity of leaks and the need for reoperation compared with no diversion. The choice between LI and TC remains controversial. Loop ileostomy is technically straightforward and associated with shorter operative time and fewer septic complications at closure. However, it carries specific risks, including high-output stoma, dehydration, electrolyte imbalance, and renal impairment, which may lead to hospital readmissions. Conversely, loop transverse colostomy is associated with fewer fluid and electrolyte issues, but has higher rates of prolapse, skin irritation, and wound complications at closure. Meta-analyses comparing LI and TC indicate no clear superiority, with each approach demonstrating distinct patterns of morbidity. Some randomized trials have suggested lower major morbidity with LI, while others found no significant difference. Given the heterogeneity of outcomes and limited high-quality, adequately powered trials, further randomized evidence is needed to guide optimal stoma selection in colorectal surgery.

Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal Surgery

This study is a clinical research project conducted at Xijing Hospital to compare the effects of two different neuromuscular blockade reversal strategies on the recovery of gastrointestinal (GI) function after colorectal surgery. Many patients experience slow recovery of bowel function after colorectal surgery, which can lead to discomfort, nausea, vomiting, and a longer hospital stay. This study investigates whether using one medication (sugammadex) to reverse muscle relaxants used during anesthesia leads to better and faster recovery of gastrointestinal function compared to a traditional combination of medications (neostigmine with atropine). The study will include 560 adults scheduled for elective colorectal surgery. Participants will be randomly assigned to one of two groups to receive either: Sugammadex (2 mg/kg), OR Neostigmine (30 μg/kg) + Atropine (15 μg/kg) The assigned study drug will be given by intravenous injection at the end of surgery, once measurements show the muscle relaxant is starting to wear off. The patients, surgeons, outcome assessors, and statisticians will be blinded. The main goal is to see if more patients in one group recover their gastrointestinal function within 72 hours after surgery. Gastrointestinal recovery is strictly defined as both being able to tolerate food/drinks without significant nausea/vomiting AND having passed gas or had a bowel movement. The study will also compare many other important outcomes between the groups, including: 1. Time to first passage of gas, first bowel movement, and first toleration of food. 2. Pain scores and opioid pain medication use. 3. Rates of nausea and vomiting. 4. Overall quality of recovery and patient satisfaction. 5. Length of hospital stay and total hospitalization costs. 6. Occurrence of complications within 30 days after surgery. 7. The safety of both reversal strategies will be closely monitored throughout the study by recording any adverse events. This research aims to provide high-quality evidence to help anesthesiologists and surgeons choose the best method to reverse muscle relaxation, potentially leading to faster recovery, fewer complications, and a better overall experience for patients undergoing colorectal surgery.

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.

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.

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

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)

Readmission and Dehydration Prevention in Patients With Elective Ileostomy

The goal of this prospective observational study is to evaluate the adherence to DRIP score calculation and the application rate of each proposed item to prevent dehydration and readmission in patients undergoing ileostomy creation after elective colorectal resection different Italian colorectal surgical centers. The primary endpoint is to verifythe application rate of DRIP score calculation and protocol items. Secondary endpoints are 30, 90, and 180-day total and dehydration readmission rates.

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.

Reflexology Massage and Hot Water Foot Bath for Pain and GI Recovery After Colorectal Surgery

This study was planned to examine the effect of non-invasive treatment methods that can be applied to alleviate complications involving gastrointestinal system functions such as pain, nausea, vomiting, and absence of gas/faecal output after colorectal (colon and rectum) cancer surgery. The two main intervention methods of the study were reflexology massage and hot water foot bath. The effects of these methods on reducing postoperative pain and improving gastrointestinal functions will be investigated. The study was planned as a randomised controlled experimental study to determine the effects of reflexology massage and hot water foot bath on postoperative pain and gastrointestinal functions in colorectal cancer patients undergoing laparoscopic surgery. It is thought that the study will provide evidence for determining the appropriate method to reduce pain and improve gastrointestinal functions in patients undergoing colorectal cancer surgery. The population of the study will consist of colorectal cancer patients who will undergo laparoscopic surgical intervention who are admitted to the General Surgery Clinic of SBU Istanbul Ümraniye Training and Research Hospital. Based on the percentage measurement values of the methods to be studied in the literature review, G-POWER programme was used for sample calculation with an effect size of 0.4 (Cohen), 95% power and 0.05% margin of error. Cohen\&#39;s standard effect size was taken as the basis for the effect size. The calculated value is the total value for 3 groups and the total sample size for 3 groups was found as n=102. The number of samples per group was determined as (n)=34. In order to prevent bias in the study, patients who meet the study criteria will be distributed to the experimental and control groups by computerised randomisation programme. Data will be collected by using the Patient Information Form consisting of two parts, Rhodes Nausea, Vomiting and Retching Index and Numerical Proportioning Scale (NRS) developed by the researcher in line with the literature. The data obtained will be evaluated with appropriate statistical methods in the licensed SPSS 21.0 package programme.

Surgical Site Infection Outcomes in Natural Orifice Intracorporeal Anastomosis and Extraction (NICE) Procedure - The NICE Trial

The goal of this observational study is to learn if a new surgical technique, called the NICE procedure, is as safe as standard methods for treating benign left-sided colon and rectal diseases in adults. The main question it aims to answer is: Does the NICE procedure lead to similar or lower rates of surgical site infections (SSIs) within 30 days compared to traditional surgery? Researchers will gather information from hospitals across the country to evaluate how well this procedure works when performed by experienced surgeons in everyday clinical settings. Participants will: Have surgery using the NICE procedure, which uses a robotic platform and removes the specimen through a natural opening (the rectum). Be monitored for any infections or complications after surgery. Complete surveys to track their recovery, bowel function, and quality of life for up to 6 months. This study may help improve recovery, reduce pain, and lower infection risk in future colorectal surgeries.

Evaluating the Effective and Safe Use of Stream™ Platform

The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use. Additionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.

AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer

Surgery can effectively treat colorectal cancer, but it is a complex procedure with risks and complications. Surgeons often rely on cameras to visually guide their instruments during operations, especially in minimally invasive ("keyhole") and endoscopic procedures. The camera is connected to a computer and generates the internal scene onto a display screen, which the surgeon looks at throughout the procedure, helping them make informed decisions throughout the operation. Fluorescence-guided surgery uses a particular type of camera that can detect images in both normal light and in the near-infrared range. To work, it needs the administration of an agent called indocyanine green to a patient and then the camera can see if the agent is in the tissue of interest to the operation at the time of the surgery. In this way, decisions regarding blood supply ("perfusion") can be helped, especially related to safety in joining together portions of tissue after removal of disease. The equipment and agent are approved for use in this way and have very good safety profiles. Many international studies have already demonstrated that the use of fluorescence-guided surgery is associated with lower rates of leaks when disease bowel segments are removed, and the healthy ends are joined back together. Previous work we have done has shown that sophisticated computing methods can learn to interpret the fluorescence patterns to a similar standard as a surgeon who is very experienced in fluorescence-guided surgery. In this study, we aim to assess whether the computer system we have developed work in real-time, in theatre to provide a reliable interpretation of the fluorescence pattern, that would match how an expert would interpret the same pattern. The system's analysis will not impact on the operation; instead, video images will be recorded, processed and analysed by our computer system. The results of the interpretation will not be shown to the operating surgeon during the procedure to avoid any impact on decision-making.