[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenocarcinoma-of-the-colon\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenocarcinoma-of-the-colon":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,76,99,122,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100445456","five-or-ten-year-colonoscopy-for-1-2-non-advanced-adenomatous-polyps-100445456",false,"NCT05080673","Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps","FORTE","Inclusion Criteria:\n\n* The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.\n* Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy.\n* Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization.\n* Sessile serrated polyps\u002Fadenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas.\n* Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization.\n* Complete excision of all observed polyps in qualifying colonoscopy\n* Participants must be able to read or understand English or Spanish.\n\nExclusion Criteria:\n\n* • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps\u002Fadenomas excluding those found on the qualifying colonoscopy.\n\n  * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.\n  * Traditional serrated adenomas found on the qualifying colonoscopy.\n  * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.\n  * Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin.\n  * Colonoscopy performed after the qualifying colonoscopy but prior to randomization.\n  * Incomplete qualifying colonoscopy (e.g., cecum not visualized).\n  * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)\n  * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)\n  * Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age.\n  * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \\[Lynch Syndrome\\]).\n  * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \\[Lynch Syndrome\\] genetic mutation that increases risk of colorectal cancer.\n  * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).\n  * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.\n  * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.","ALL","45 Years","70 Years",{"count":20,"type":21},9500,"ESTIMATED","INTERVENTIONAL",[24],"NA","This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.",[27,28],"Adenocarcinoma of the Colon","Adenocarcinoma of the Rectum","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2022-02-09",{"date":37,"type":21},"2065-11-01",{"name":39,"class":40},"NRG Oncology","OTHER",485,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100617475","liquid-biopsy-in-early-colorectal-lesions-100617475","NCT07319104","Liquid Biopsy in Early Colorectal Lesions","Biobank for Validating Liquid Biopsy in Predicting the Prognosis of Superficial Colonic Lesions","FECCO-BioBank","Inclusion Criteria:\n\n* Patient of legal age (≥ 18 years)\n* Patient with a superficial colonic tumor refered for submucosal dissection\n* Patient included in the FECCo cohort (patients will be included concomitantly in FECCO-Biobank)\n* Patient wishing to participate in the FECCO-BioBank biological collection\n\nExclusion Criteria:\n\n* Person with significant comorbidities preventing blood sampling\n* Patients with a distant metastasis detected by imaging\n* Person unable to read and write French\n* Person who have expressed their opposition to participating in this research after being informed by an investigator and having read the information sheet\n* Person not benefiting from a national health insurance scheme\n* Person under legal protection, guardianship or curatorship\n* Person participating in other study with an ongoing exclusion period","18 Years",{"count":52,"type":21},1000,"3 Months","OBSERVATIONAL","Early colorectal cancer screening increasingly detects small superficial colonic lesions, but current diagnostic tools still struggle to distinguish benign from malignant lesions and to assess lymph node risk. As histology after resection has limited accuracy, many patients undergo unnecessary surgery.\n\nLiquid biopsy, analyzing circulating biomarkers such as tumor DNA, extracellular vesicles, and nucleosomes, offers a non-invasive way to better classify these lesions. Emerging evidence suggests it may outperform current criteria for predicting lymph node involvement in T1 colorectal cancer.\n\nThis study will establish a biobank of 1,000 patients to identify blood-based signatures that predict tumor stage and lymph node status. The hypothesis of the study is that circulating biomarkers can accurately differentiate benign from malignant lesions and identify patients with or without lymph node metastasis.",[57,58,27],"Colorectal Neoplasms","Precancerous Conditions",[60,61,62,63,64],"Lymphatic Metastasis","Endoscopy, Gastrointestinal","Liquid Biopsy","Biomarkers","Biobanking","NOT_YET_RECRUITING","2026-05-29",{"date":68,"type":33},"2026-06-02",{"date":70,"type":21},"2026-06-15",{"date":72,"type":21},"2031-12-15",{"name":74,"class":40},"University Hospital, Montpellier",12,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":5},"100454421","phase-2-neoadjuvant-pembrolizumab-in-stratified-medicine---colorectal-cancer-100454421","NCT05197322","NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer","NEOPRISM-CRC : Neoadjuvant Pembrolizumab Stratified to Tumour Mutation Burden for High Risk Stage 2 or Stage 3 MMR-deficient Colorectal Cancer","NEOPRISM-CRC","Inclusion Criteria:\n\n1. Histologically proven adenocarcinoma of the colon or rectum which is MMR-d by IHC or MSI-H by PCR (or microsatellite testing if routine practice).\n2. Patient is fit (ECOG 0-1) and eligible for planned curative surgery in keeping with NICE guidelines and considered fit\u002Fsuitable for adjuvant chemotherapy as per local site investigator's discretion based on:\n\n   1. Radiological node positive T1-4 CRC or\n   2. Node negative high risk T3 defined as EITHER ≥ 5mm of extramural depth of invasion OR unequivocal EMVI on imaging (regardless of depth) or Node negative T4 disease\n3. Patients with rectal cancer are eligible if it is determined that neoadjuvant chemo-radiotherapy is not required to achieve a R0 resection.\n4. Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma\u002Fstent, and when recovered to a fitness level consistent with the other eligibility criteria\n5. Adequate bone marrow function:\n\n   * White Blood Cell \\>3.0 x 10\\^9\u002FL;\n   * Absolute neutrophil count ≥1.5 x 10\\^9\u002FL\n   * Platelets ≥100 x 10\\^9\u002FL.\n   * Haemoglobin ≥90 g\u002FL\n6. Adequate renal function:\n\n   GFR \\>50 mL\u002Fmin estimated using validated creatinine clearance calculation (e.g. Cockroft-Gault) NB If the calculated creatinine clearance is \\\u003C 50 mL\u002Fmin, a formal 24 hour urine collection or isotope clearance must be carried out demonstrating GFR ≥ 50 mL\u002Fmin as per institutional standards\n7. Adequate liver function:\n\n   Total bilirubin \\\u003C 1.5 times Upper Limit of Normal (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n\n   AST and ALT ≤ 2.5 × ULN\n8. Adequate coagulation:\n\n   International normalized ratio (INR) OR prothrombin time (PT) and Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n9. Aged ≥18 years\n10. Able and willing to provide written informed consent\n11. Female patients of child bearing potential must be willing to use highly effective contraception for the duration of trial treatment and for 120 days after last dose of pembrolizumab\n\nExclusion Criteria:\n\n1. Any patient for whom radiotherapy is advised by the MDT\n2. Strong evidence of distant metastases or peritoneal nodules (M1)\n3. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)\n4. Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to registration.\n\n   (NB: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline, with the exception of alopecia. Participants with ≤Grade 2 neuropathy may be eligible.) (NB: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.)\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to registration (seasonal flu vaccines that do not contain live virus are permitted). Administration of killed vaccines is allowed\n6. Any investigational agents or investigational devices within 4 weeks prior to registration Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisolone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment Note: the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC.\n8. Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial\n9. Has known active CNS metastases and\u002For carcinomatous meningitis.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For to any of its excipients.\n11. Has previous severe or life-threatening skin adverse reaction with other immune-stimulatory anticancer agents\n12. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n    NB: Replacement therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.\n13. History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids, or current pneumonitis\u002Finterstitial lung disease\n14. Active infection requiring systemic therapy\n15. Known history of Human Immunodeficiency Virus (HIV). NB: Testing for HIV for the NEOPRISM-CRC trial is not mandatory, however if this test has been done the result should be known prior to registration.\n16. Known active infection for hepatitis B (hepatitis B surface antigen \\[HbsAg\\] reactive) or known active hepatitis C (defined as hepatitis C virus \\[HCV\\] RNA \\[qualitative\\] is detected)\n\n    * Testing is required to determine eligibility. Hepatitis C antibody testing is allowed for initial screening purposes in sites where HCV RNA is not part of standard of care.\n    * Patients who are HbsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration. Participants should remain on anti-viral therapy throughout trial treatment and follow local guidelines for HBV anti-viral therapy post completion of trial treatment.\n    * Patients with history of HCV infection are eligible if HCV viral load is undetectable at screening and have completed anti-viral therapy at least 4 weeks prior to registration.\n17. Known history of active TB (Mycobacterium tuberculosis).\n18. Has had an allogenic tissue\u002Fsolid organ transplant.\n19. Has peritonitis (secondary to perforated tumour)\n20. Has a colonic obstruction that has not been defunctioned or stented\n21. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n22. Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n23. Female patients of child bearing potential who is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of pembrolizumab",{"count":85,"type":21},88,[87],"PHASE2","Colorectal cancer (CRC) is the 2nd to 3rd most common malignant disease in developed countries, with over 1 million new cases and 500,000 deaths worldwide each year. The primary treatment for early stage CRC is surgery to remove the tumour, which is possible in 80% of patients. Even after surgery up to half of patients will develop recurrence or spread of the disease (metastases) which is incurable. Survival after 5 years is approximately 14% for patients with metastatic disease. Clinical trials using immunotherapy drugs called 'immune checkpoint inhibitors' have shown excellent results in advanced colorectal cancer patients who have certain genetic characteristics called 'mismatch repair deficiency (MMR-d)' and 'high microsatellite instability (MSI-h)'. The benefits of immunotherapy as a treatment prior to surgery to remove the tumour (neoadjuvant treatment) has been observed in both melanoma and in glioblastoma with enhanced local and systemic anti-tumour responses.\n\nPembrolizumab is an immunotherapy drug and works by helping the body's own immune system to fight the cancer cells. The NEOPRISM-CRC trial will investigate whether giving pembrolizumab before surgery is safe, whether it improves the chances of the tumour being removed completely and whether it delays or prevents the cancer from coming back.\n\nPembrolizumab treatment lasts for a maximum of 9 weeks (maximum of 3 cycles of treatment, each cycle consisting of 3 weeks) and is given prior to surgery. Following surgery patients will be followed up for at least 3 years after their surgery and to a maximum of 5 years. Target recruitment is 88 patients and recruitment is expected to take place over a 48 month period.\n\nBlood, tissue, mouth swabs and stool samples will be collected from patients throughout the trial to better understand the biology of immunotherapy as a treatment for CRC prior to surgery.",[27],"2026-04-14",{"date":92,"type":33},"2026-04-17",{"date":94,"type":33},"2022-07-20",{"date":96,"type":21},"2029-07-31",{"name":98,"class":40},"University College, London",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100410442","the-utility-and-feasibility-of-mt-sdna-as-a-surveillance-procedure-in-colorectal-cancer-survivors-100410442","NCT04624555","The Utility and Feasibility of Mt-sDNA as a Surveillance Procedure in Colorectal Cancer Survivors","Inclusion Criteria:\n\n* Diagnosis of stage I, II or III adenocarcinoma of the colon or rectum\n* Receipt of preoperative colonoscopy\n* Receipt of bowel resection; use of adjuvant chemotherapy or radiation therapy as clinically indicated\n\nExclusion Criteria:\n\n* Stage IV colorectal cancer\n* Surgical treatment with subtotal colectomy or total proctocolectomy\n* Diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)\n* Diagnosis of polyposis syndrome including Lynch syndrome or familial polyposis\n* Presence of advanced adenomas (1 cm or larger, villous features and\u002For high grade dysplasia) that were not removed at the preoperative colonoscopy or contained in the resection specimen.\n* Inability to provide informed consent\n* Inability to understand spoken and written English\n* Medical comorbidities that would be contraindications to sedation or that would preclude any benefit of routine surveillance post-resection. These would be at the discretion of the participant's providers.",{"count":106,"type":21},50,"The purpose of this research study is to determine whether testing of stool for a panel of markers will enable us to detect polyps and cancer compared to standard testing.",[27,28,109,110,111],"Stage I Colorectal Cancer","Stage II Colorectal Cancer","Stage III Colorectal Cancer","2026-04-06",{"date":114,"type":33},"2026-04-09",{"date":116,"type":33},"2022-10-31",{"date":118,"type":21},"2026-09-01",{"name":120,"class":40},"Case Comprehensive Cancer Center",1,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":121},"100413844","biopsy-after-radioembolization-to-identify-changes-in-tumor-cells-from-the-radiation-100413844","NCT04668872","Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation","Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study","Inclusion Criteria:\n\n* age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* histologically confirmed primary adenocarcinoma of the colon or rectum\n* CLM considered unresectable or not amenable to percutaneous ablation\n* existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease.\n* adequate blood cell counts (WBC \\> 1.5 x 109\u002FL, platelet count \\> 50 x 109\u002FL)\n* adequate renal function (creatinine \\\u003C 1.5 mg\u002FdL)\n* total bilirubin level ≤ 1.5 mg\u002FdL\n\nAdditional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:\n\nA. patients not amenable to surgery or thermal ablation\n\nExclusion Criteria:\n\nStudy exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:\n\n* prior hepatic radiotherapy (The lesion \u002F lobe being treated cannot have had prior treatment with radiotherapy - untreated lesions \u002F lobes in the liver may be evaluated under the protocol)\n* severe cirrhosis\n* severe portal hypertension\n* uncorrectable flow to the gastrointestinal tract and\u002For \\>30 Gy (or \\>50 Gy in multiple sessions) radiation absorbed dose to the lungs\n\nAll patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.",{"count":130,"type":21},80,"The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.",[133,134,27,28,135,136],"Colon Cancer Liver Metastasis","Colon Cancer","Liver Metastasis Colon Cancer","Colorectal Cancer",[138,139,140,133,134,27,28,136,141,142],"colorectal liver metastases","transarterial radioembolization","Y90 TARE","Memorial Sloan Kettering Cancer Center","20-355","2026-03-11",{"date":145,"type":33},"2026-03-12",{"date":147,"type":33},"2020-12-07",{"date":149,"type":21},"2026-12-07",{"name":141,"class":40},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":121},"100602899","ultrasonic-versus-conventional-clipping-hemostasis-in-laparoscopic-colorectal-surgery-100602899","NCT07129512","Ultrasonic Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery","Clipless Ultrasonic Energy-based Hemostasis Versus Conventional Clipping Hemostasis in Laparoscopic Colorectal Surgery: A Pilot Study","Inclusion Criteria:\n\n* Adults 19 to 80 years of age\n* Patients with histologically confirmed pathologic adenocarcinoma of the colon\n* Patients with an ECOG score between 0 and 2\n* Patients with a preoperative ASA score of I to III\n* Patients without a history of surgery for abdominal malignancies\n* Patients with no history of anticoagulation prior to surgery\n* Patients who understand the study process and treatment plan and are able to complete the informed consent form themselves\n\nExclusion Criteria:\n\n* Patients with an ASA score of 4 or higher\n* People with blood clotting disorders such as liver cirrhosis, end-stage renal failure, or hematologic disorders\n* Pregnant women\n* Mentally ill patients who have difficulty giving informed consent\n* Preoperative blood hemoglobin (Hb) less than 7 g\u002FdL\n* Patients taking anticoagulants before or after surgery\n* Patients who have undergone emergency surgery\n* Patients who are unable to be followed up on an outpatient basi\n* No Informed consent","19 Years","80 Years",{"count":161,"type":21},304,[24],"INTRODUCTION Colorectal cancer rates are rising, with surgery emphasizing radical resection and vessel ligation. Conventional methods using clips pose risks of bleeding and complications. Ultrasonic scalpels offer a safer alternative, approved for various surgeries, but their efficacy in colorectal cancer surgery needs prospective validation.\n\nSTUDY OBJECTIVE Study compares safety\u002Fefficacy of clipless vs. clip-type hemostasis using ultrasonic scalpel in colorectal surgery, focusing on post-op bleeding frequency, intraoperative bleed, drainage, hospital stay.\n\nSTUDY DESIGN This study is a prospective, randomized, single-center study comparing clipless ultrasonic energy-based hemostasis versus conventional clipping hemostasis in performing laparoscopic colectomy. The study's experimental group undergoes surgery with an ultrasonic scalpel, while the control group receives treatment with a monopolar energy device and clips. Allocation to groups, using a 1:1 ratio, is randomized via a computerized table by a blinded coordinator, immediately post-anesthesia. Principal investigators and administrators remain blinded throughout the study.\n\nSTUDY POPULATION\n\n1\\. Screening A detailed review of the medical records will be performed to assess inclusion\u002Fexclusion criteria for all subjects who have been diagnosed with colonic adenocarcinoma and are subject to a colectomy procedure.\n\nAll patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site.\n\nRISK ANALYSIS The surgical procedure, postoperative care, and follow-up will be the same for the experitmental and control groups in this study. The use of the ultrasonic scalpel alone may prevent complications such as clip-induced intestinal obstruction, infection, bleeding from clip dislodgement, bile leakage, and infection, but there is no additional benefit for other subjects. The risk of bleeding when ligating vessels with an ultrasonic scalpel has been demonstrated to be safe in retrospective studies for vessels 7 mm or less (8-17). Vessels larger than 7 mm are ligated using surgical clips because the safety of ligation with the ultrasound scalpel has not been studied. Based on the reported safety of this method of ligation, the risks do not outweigh the benefits when analyzed in the aggregate.\n\nQUALIFICATION OF PARTICIPATING SURGEONS\n\n1. Surgical procedure\n\n   * Laparoscopic surgery: Surgery for colorectal cancer consists of ligating blood vessels to the lesion, detaching or mobilizing the colon, and resecting and anastomosing the bowel.\n   * Clipless ultrasound energy-based hemostasis arm: the ultrasound scalpel is used to dissect and ligate the vessel, but clips are used for vessels larger than 7 mm in diameter. If there is significant bleeding during the procedure, surgical clips and hemostatic agents may be used for patient safety at the discretion of the surgeon.\n   * Control arm: a combination of monopolar cautery and surgical clips will be used for vascular ligation and lymph node dissection.\n2. Procedure standardization and qualification procedure This study is about laparoscopic surgery for colorectal cancer and all surgeries will be performed by surgeons with at least 100 laparoscopic colorectal cancer surgeries.\n\nSTATISTICAL ANALYSIS This study compares the frequency of postoperative bleeding between clipless and clip-type ultrasound energy hemostasis in laparoscopic colorectal cancer surgery, assuming that there will be deviations from randomization, such as switching of surgical groups after randomization or additional vessel ligation with clips during or after surgery, we will perform a per-protocol analysis.\n\nThe missing values of postoperative bleeding, intraoperative blood loss, intraoperative blood transfusion, and conversion to laparotomy are assumed to be none, and the missing values of postoperative drainage tube hematocrit and drainage tube triglycerides are converted to the mean values of the same group. Outliers will be retained without replacement for intraoperative blood loss, operative time, maximum postoperative plasma hemoglobin decline, and total drainage volume within 5 days postoperatively.\n\nFor Type 1 errors, the frequency of postoperative intra-abdominal bleeding in the control group will be analyzed during data safety monitoring every 50 cases to ensure that it is less than 0.5-4.5% according to the literature.",[27],"2025-08-11",{"date":167,"type":33},"2025-08-19",{"date":169,"type":33},"2024-03-04",{"date":171,"type":21},"2025-09-24",{"name":173,"class":40},"Yonsei University"]