Clinical Research Directory

Surgical Intuition in Anastomotic Leakage After Colorectal Surgery

The SURGUT study aims to assess how well a computer model predicts bowel leaks after surgery. It will also examine whether adding surgeons' intuition improves these predictions. The study will include adults having surgery to remove part of the colon or rectum. During the operation, the remaining bowel ends are joined together. Sometimes, this connection does not heal properly and a leak develops. This is called an anastomotic leak and can cause serious complications. The research questions are: * How well does a previously developed computer model predict a leak within 30 days after surgery? * How accurately do surgeons estimate the risk of a leak? * Does combining the computer model with surgeons' assessments improve prediction compared with the model alone? This observational study will take place at several hospitals in different countries. Researchers will collect information about participants' health, surgery, and presence of complications. Surgeons will complete a pre-operative and an immediately post-operative questionnaire about the estimated risk of a leak, surgical difficulty, and concerns about the bowel connection. Researchers will record whether a leak occurs within 30 days after surgery. They will compare these outcomes with the predictions from the computer model, surgeons' assessments, and the combination of both. The findings may help improve how clinicians identify people at higher risk of a leak after bowel surgery.

Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area

This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal surgery in a prospective multi-center study.

Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery

To evaluate the safety and effectiveness of sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE for the treatment of anastomotic leaks in the upper gastrointestinal tract in a prospective multi-center study.

Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.

Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery

The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations. The main question it aims to answer is: Does using ICG fluorescence imaging during bowel anastomosis reduce the rate of complications such as leaks, infections, and abscesses within 30 days after surgery? Participants are women aged 18 and older undergoing surgery for gynecologic cancers (such as ovarian, uterine, cervical, or vulvar cancer). During surgery, investigators will inject ICG intravenously, then use a special near-infrared camera to see how well blood flows at the anastomosis site. The investigators will then decide if the reconnection is good enough or needs adjustment. Researchers will record any complications within the first 30 days after surgery to understand if this imaging method helps reduce surgical risks.

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.

Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.

This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.