Clinical Research Directory

CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery

Cancer of the lowermost part of the intestine (the rectum) is a common disease and both this disease and its treatment can have major impact on patients. Unless treated early, the disease can progress, spread to other parts of the body and ultimately cause death. Treatment often involves radical surgery, but this too has consequences and risks major complications. Best outcomes regarding cure with least impact depend on the disease being detected at an early stage as rectal cancer tends to start first as a non-cancerous polyp. The smallest of these precursor polyps can be easily removed during a routine colonoscopy but once the polyp grows over 2cm in size it is much harder to categorise correctly as the risk of it containing cancer somewhere in it increases markedly. If there is definitely cancer present in such a polyp it is best treated from the outset as a cancer with major surgery, but if there is definitely not a cancer in it then it can be removed from inside the bowel with minimally invasive techniques. Unfortunately, despite our current very best methods, up to 20% of tumours initially thought to be benign are found to be malignant only after they are excised We have previously shown that cancerous and non-cancerous tissues can be visually differentiated by analysis of their perfusion during the examination. For this we use a specific approved fluorescent dye, indocyanine green (ICG). ICG is commonly used in bowel surgery anyway to assess the blood supply to the bowel and has a very good safety profile. ICG is injected into the bloodstream during surgery and the rate at which it is taken up by various tissue types is detected by specific and approved cameras which can reveal fluorescence in tissue. We have previously found that the rate of uptake of this dye is different in cancer tissue compared to non-cancer tissue and have used artificial intelligence algorithms to measure this difference. However, we now need to ensure that this method can work also in other patients, in other centres and indeed in other countries to ensure it is indeed a valid and useful way of assessing rectal polyps. The goal of this observational study is to validate the use of fluorescence pattern analysis in the classification of rectal tumours. Patients enrolled in the study will attend for a visual examination of the rectal tumour in theatre as is standard practice. During this examination a video recording of the fluorescence perfusion will be taken following ICG administration. Patients will then have the tumour excised or treated as is standard of care by their surgeon. The video will later be analysed to determine the pattern of fluorescence perfusion within the tumour, and a classification will be assigned based on the pattern seen. All tumours that are excised are examined under the microscope by a pathologist to determine the final diagnosis. The fluorescence based classification will be compared to this pathological diagnosis to determine the accuracy of the method. So, patients will still have the exact same standard of care as currently happens, the hope is that in future this method can be developed to the point where it could be useful by means of a useable, accurate automated software process. If so, that will form the basis of another study in the future to look to see if it can guide or even replace biopsies and help with ensuring complete removal ('clear margins') after excision.

Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial

Study Purpose: This study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care. Background: Rectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2) Current Knowledge: Advances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery. Past studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5) Need for the Study: There is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most. Study Design: This study is a randomized controlled trial that will: * Compare PFR to usual care in patients after LAR surgery. * Focus on bowel control and quality of life. * Provide detailed insights to improve aftercare for rectal cancer patients.

Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment

Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE). A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure. The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer. The main question it aims to answer are: • How frequently does LE allow for rectum preservation? Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.