[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectum-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectum-neoplasm":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100500230","classica-validating-ai-in-classifying-cancer-in-real-time-surgery-100500230",false,"NCT05793554","CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery","Inclusion Criteria:\n\n* Participants with a confirmed or suspected rectal polyp\u002Ftumour measuring greater than 2cm undergoing surgical intervention or assessment OR Patients with a known rectal cancer undergoing surgical intervention or assessment, including those post neo adjuvant therapy.\n* Participant is willing and able to give informed consent for participation in the study. ● Male or Female, aged 18 years or above.\n* Clinically fit for elective intervention\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning pregnancy within three months of the study\n* Significant renal or hepatic impairment.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. ● Allergy to intravenous contrast agent or iodides\n* Other contraindications to ICG including concurrent use of anticonvulsants, bisulphite containing drugs, methadone and nitrofurantoin.","ALL","18 Years",{"count":18,"type":19},600,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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\n\nWe 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.\n\nThe 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.",[23,24,25],"Rectum Neoplasm","Rectum Polyp","Rectal Cancer",[27,28,29,30],"Fluorescence","Indocyanine green","Tumour classification","Artificial Intelligence","RECRUITING","2025-01-15",{"date":34,"type":35},"2025-01-17","ACTUAL",{"date":37,"type":35},"2023-03-31",{"date":39,"type":19},"2027-03",{"name":41,"class":42},"Mater Misericordiae University Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":43},"100556381","effect-of-pelvic-rehabilitation-after-low-anterior-resection-for-cancer-rectum---a-randomised-controlled-trial-100556381","NCT06524362","Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial","Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial (PERECARE TRIAL)","PERECARE","Inclusion Criteria:\n\n* Age: Adults aged 18 years or older.\n* Surgical Procedure: Have undergone Low Anterior Resection (LAR) for rectal cancer.\n* Cognitive Ability: Capable of understanding and completing the questionnaires effectively\n\nExclusion Criteria:\n\n* Medical History: History of proctitis, ulcerative colitis, or Crohn's disease.\n* Surgical Extent: Extensive resection (beyond Total Mesorectal Excision - TME) for\n* locally advanced (T4) tumors, patients undergoing APR.\n* Surgical Complications: History of anastomotic leakage.\n* Recent Physiotherapy: History of invasive physiotherapy within the past 6 months.\n* Mental or Physical Inabilities: Inability to undergo Pelvic Floor Rehabilitation due to mental or physical limitations","85 Years",{"count":54,"type":19},77,"INTERVENTIONAL",[57],"NA","Study Purpose:\n\nThis 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.\n\nBackground:\n\nRectal 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)\n\nCurrent Knowledge:\n\nAdvances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery.\n\nPast studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5)\n\nNeed for the Study:\n\nThere is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most.\n\nStudy Design:\n\nThis study is a randomized controlled trial that will:\n\n* Compare PFR to usual care in patients after LAR surgery.\n* Focus on bowel control and quality of life.\n* Provide detailed insights to improve aftercare for rectal cancer patients.",[25,23,60,61,62,63,64],"Rectal Neoplasms","Rectal Adenocarcinoma","Low Anterior Resection Syndrome","Fecal Incontinence","Bowel Dysfunction",[66,67,68,69,70,71,72,73,74,75,76],"Pelvic Floor Rehabilitation","Low Anterior Resection","Ultra Low Anterior Resection","Rectal Cancer Surgery","Post operative care","Bowel function","Quality of life","Randomized controlled trial","Fecal Urgency","Pelvic Floor Muscle Training","Oncological outcomes","NOT_YET_RECRUITING","2024-07-23",{"date":80,"type":35},"2024-07-29",{"date":82,"type":19},"2024-08",{"date":84,"type":19},"2026-03",{"name":86,"class":42},"GEM Hospital & Research Center",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":95,"targetDuration":97,"studyType":20,"phases":4,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":43},"100510526","local-excision-for-organ-preservation-in-early-rectal-cancer-with-no-adjuvant-treatment-100510526","NCT05927584","Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment","Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment (LORENA Trial).","LORENA","Inclusion Criteria:\n\n* Patients age 18 years or older.\n* Histologic proof of infiltrating rectal adenocarcinoma. or\n* Preoperative biopsy compatible with rectal adenoma or intramucous adenocarcinoma with endoscopic or radiological suspicion of infiltrating adenocarcinoma.\n\n  1. Endoscopic criteria: Kudo´s crypt pattern of V or higher, despite non confirmatory preoperative histology. endoscópicos: patrón de criptas V o superior según la clasificación de Kudo, que define lesiones infiltrantes, a pesar de que la histología preoperatoria no sea confirmatoria .\n  2. Ultrasonographic criteria: hipoecogenic rectal tumor invading the intermediate hyperecogenic layer (submucosal), but does not infiltrate the hypoecogenic outer layer (muscularis propia).\n  3. Radiological criterio in MR: tumor invades the submucosal layer without infiltration of the rectal muscularis propia. The usual low signal submucosal image is substituted with an aberrant signal, meaning the loss of the zebra pattern in a normal rectal wall.\n* Rectal neoplasm with an inferior limit no further than 2cm proximal to the anorectal verge, both in digital rectal examination and in radiology examinations, ideally magnetic resonance (MR).\n* Rectal neoplasms up to 3 cm of major diameter.\n* Clinical preoperative staging of cT1N0M0, based on endoscopy, MR, +\u002F- endorectal ultrasound.\n* Cases in which LE as exclusive treatment with curative intent is prescribed after MDT discusión, regardless of the approach both via flexible endoscopy and transanal endoscopic microsurgery and its variations.\n* Neoplasms with low risk histologic criteria known preoperatively or lack of information regarding this aspect:\n\n  1. Submucosal infiltration of less than 1000µm (sm1 in the Kikuchi classification) .\n  2. Tumor budding absent.\n  3. En bloc resection in patients with a previous endoscopic resection.\n  4. Vascular, lymphatic and perineural invasión absent.\n  5. Low histologic grade.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.\n* Rectal neoplasms different from adenocarcinoma.\n* Neoplasms in which the inferior edge is farther than 2cm proximal to the anorectal verge in the preoperative MR.\n* Any other clinical stage other than cT1N0M0 (any T\\>1, N+, or M+).\n* Neoplasms larger than 3cm.\n* Preoperatively demonstration of PPHF:\n\n  1. Submucosal infiltration deeper than 1000µm (sm2 and sm3 in the Kikuchi classification)\n  2. Tumor budding present.\n  3. Piecemeal resection in cases with previous endoscopic resection.\n  4. Vascular, lymphatic and perineural invasión presence.\n  5. High histologic grade.\n* Any patient with planned systemic treatment with RTQT combined with the LE after MDT discusión, regardless of the preoperative clinical or postoperative pathological stage.",{"count":96,"type":19},145,"36 Months","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).\n\nA 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.\n\nThe 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.\n\nThe main question it aims to answer are:\n\n• How frequently does LE allow for rectum preservation?\n\nParticipants 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.",[25,23],[101,102,103,104],"Early rectal cancer","Local excision","Total Mesorectal Excision","Organ preservation","2024-05-13",{"date":107,"type":35},"2024-05-14",{"date":105,"type":35},{"date":110,"type":19},"2027-05-01",{"name":112,"class":42},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa"]