[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ZHI-ZHONG PAN\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100554189","phase-2-prospective-phase-ii-study-on-continuous-circumferential-reinforcement-of-laparoscopic-rectal-anastomosis-to-prevent-complications-100554189",false,"NCT06495853","Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications","A Prospective Phase II Clinical Study on Continuous Circumferential Reinforcement of the Anastomotic Site With Laparoscopic Rectal Anastomosis to Prevent Complications.","Inclusion Criteria:\n\nHistological Confirmation:\n\nDiagnosed with rectal adenocarcinoma confirmed by histology.\n\nTumor Location:\n\nMRI confirms a mid to upper rectal tumor, with the lower margin of the tumor located 6-12 cm from the anal verge.\n\nPreoperative Staging:\n\nPreoperative MRI staging indicates the presence or absence of MRF positivity and\u002For EMVI positivity; the surgical team assesses the tumor as resectable with an estimated R0 resection.\n\nBowel Obstruction:\n\nNo signs of bowel obstruction.\n\nNeoadjuvant Chemoradiotherapy:\n\nFor patients who have received neoadjuvant chemoradiotherapy, complete radiotherapy and baseline imaging records must be available at this center.\n\nPrevious Treatments:\n\nSurgical History:\n\nNo previous colorectal surgery.\n\nBiological and Immunotherapy:\n\nNo prior treatment with biological drugs (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4), or other investigational drugs.\n\nEndocrine Therapy:\n\nNo restrictions on prior endocrine therapy.\n\nPatient Characteristics:\n\nAge:\n\nBetween 18 and 75 years old.\n\nPerformance Status:\n\nECOG performance status of 0-1 (see Appendix 3).\n\nLife Expectancy:\n\nGreater than 2 years.\n\nHematological Parameters:\n\nWBC \\> 3×10\\^9\u002FL; PLT \\> 80×10\\^9\u002FL; Hb \\> 90 g\u002FL.\n\nLiver Function:\n\nALT and AST less than 2 times the upper limit of normal; bilirubin less than 1.5 times the upper limit of normal.\n\nRenal Function:\n\nCreatinine less than 1.5 times the upper limit of normal or creatinine clearance (CCr) ≥ 60 ml\u002Fmin.\n\nExclusion Criteria:\n\nPatients meeting any of the following conditions will be excluded from the study:\n\nNeed for Multiorgan Resection:\n\nPatients requiring combined organ resection.\n\nPreventive or Permanent Stoma:\n\nPatients requiring preventive or permanent stoma.\n\nHartmann or Miles Procedures:\n\nPatients requiring Hartmann's procedure or Miles' surgery.\n\nCardiac Conditions:\n\nArrhythmias requiring antiarrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease, localized myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure beyond NYHA Class II.\n\nUncontrolled Hypertension:\n\nSevere hypertension that is not well controlled by medication.\n\nInfectious Diseases:\n\nHistory of HIV infection or active chronic hepatitis B or C with high viral DNA copies.\n\nActive Tuberculosis (TB):\n\nSubjects with active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening.\n\nSevere Infections:\n\nOther active clinically severe infections (according to NCI-CTC version 5.0).\n\nEvidence of Distant Metastasis:\n\nPreoperative evidence of distant metastasis outside the pelvis.\n\nCachexia and Organ Failure:\n\nCachexia or decompensated organ function.\n\nRadiotherapy History:\n\nHistory of pelvic or abdominal radiotherapy.\n\nMultiple Primary Colorectal Cancers:\n\nPresence of multiple primary colorectal cancers.\n\nSeizure Disorders:\n\nPatients with seizures requiring treatment (e.g., steroids or antiepileptic therapy).\n\nHistory of Other Malignancies:\n\nHistory of other malignancies within the past 5 years, except for cured in situ cervical cancer or basal cell carcinoma of the skin.\n\nSubstance Abuse:\n\nSubstance abuse or medical, psychological, or social conditions that could interfere with the patient's participation in the study or the evaluation of study results.\n\nAllergies:\n\nKnown or suspected allergies to the investigational drug or any drug related to the study.\n\nUnstable Conditions:\n\nAny unstable condition or situation that might jeopardize patient safety and compliance.\n\nPregnancy or Lactation:\n\nWomen who are pregnant or breastfeeding, and women of childbearing potential not using adequate contraceptive measures.\n\nInformed Consent:\n\nRefusal to sign the informed consent form.","ALL","18 Years","75 Years",{"count":20,"type":21},208,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the intra- and extraluminal compartments, including defects of the suture or staple lines of the neorectal reservoir. AL is classified into three grades based on clinical severity: Grade A, identified only radiologically without clinical symptoms; Grade B, presenting with localized or atypical peritonitis requiring antibiotics and local drainage but not surgery; and Grade C, causing severe peritonitis, systemic toxicity symptoms requiring urgent surgical intervention, and potentially leading to life-threatening situations.\n\nAL can prolong hospitalization, necessitate reoperation, delay chemotherapy, increase local recurrence rates, and adversely affect survival and quality of life. Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy, aiming for subsequent anastomotic healing or future digestive tract reconstruction. However, some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage.\n\nIdentified risk factors for AL after rectal cancer surgery include male gender, advanced age, hypertension, diabetes, smoking, and advanced TNM staging (III-IV). Additionally, preoperative chemoradiotherapy-induced bowel edema and fibrosis, bowel obstruction, and long-term malnutrition resulting in hypoproteinemia are significant contributors. Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies.\n\nThis single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL. We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis.",[27,28,29],"Colorectal Cancer","Anastomotic Leakage","Operation","NOT_YET_RECRUITING","2024-07-03",{"date":33,"type":34},"2024-07-11","ACTUAL",{"date":36,"type":21},"2024-07-20",{"date":38,"type":21},"2025-11-01",{"name":40,"class":41},"ZHI-ZHONG PAN","OTHER",""]