[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-neoplasm-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-neoplasm-malignant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,80,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100643035","efficacy-and-safety-of-transcutaneous-posterior-tibial-nerve-stimulation-on-fecal-continence-in-patients-undergoing-surgery-for-rectal-neoplasia-100643035",false,"NCT07632196","Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia","Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia","Inclusion Criteria:\n\n\\- Adult patients diagnosed with rectal neoplasia and who have undergone a high anterior rectal resection regardless of the surgical approach (open, laparoscopic, laparoscopic+TaTME or robotic+TaTME).\n\nExclusion Criteria:\n\n* Patients not operated or within active surveillance strategy programs (watch \\& wait)\n* Patients with ostomy\n* Patients with contraindications to the use of the neurostimulator:\n\n  * Pacemaker \u002F Defibrillator \u002F Other electronic devices\n  * History of heart problems\n  * Propensity to excessive bleeding (coagulopathies)\n  * Damage to the nervous system (epilepsy)\n  * Current pregnancy\n  * Infections or skin lesions\n  * Severe vascular disorders\n  * Active neoplasms.","ALL","18 Years",{"count":19,"type":20},84,"ESTIMATED","INTERVENTIONAL",[23],"NA","Rectal neoplasia is one of the most prevalent cancers in Spain, and the treatment of choice is total mesorectal excision (TME), as it has demonstrated significant oncological improvements. However, mesorectal excision is not without complications, and patients often experience altered bowel function in the form of low anterior resection syndrome (LARS), as well as erectile dysfunction. However, few studies evaluate faecal incontinence, as most focus on oncological outcomes.\n\nThe aim of our study is to evaluate the efficacy and safety of posterior tibial nerve stimulation on fecal incontinence, sexual dysfunction, and quality of life in patients who underwent to rectal surgery for rectal neoplasia.\n\nIt will be conducted a randomized clinical trial (1:1) with two arms: half of the patients will receive posterior tibial nerve stimulation, while the other half will undergo stimulation with subtherapeutic doses. Faecal incontinence will be assessed using the LARS and Wexner questionnaires, and quality of life and sexual function will be assessed using the Fecal Incontinence Quality of Life Scale (FIQLS) and the Colorectal Cancer Quality of Life Questionnaire (QLQ-CR38), at one month, six months and one year after surgery.",[26,27,28,29,30],"Low Anterior Resection Syndrome (LARS)","Rectal Neoplasm Malignant","Quality of Life (QOL)","Fecal Incontinence (FI)","Disorder of Ejaculation",[32,33,34,35,36,37,29],"total mesorectum excision","rectal neoplasm","randomised clinical trial","posterior tibial nerve stimulation","low anterior resection syndrome (LARS)","life quality","RECRUITING","2026-06-02",{"date":41,"type":42},"2026-06-08","ACTUAL",{"date":44,"type":42},"2026-02-06",{"date":46,"type":20},"2028-12-31",{"name":48,"class":49},"Althaia Xarxa Assistencial Universitària de Manresa","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100580005","metabolomics-to-predict-treatment-response-and-toxicities-in-rectal-cancer-100580005","NCT06831669","Metabolomics to Predict Treatment Response and Toxicities in Rectal Cancer","Metabolomic Profiles as Predictors of Treatment Response and Toxicities in Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the rectum\n* Scheduled to receive total neoadjuvant therapy\n\nExclusion Criteria:\n\n* Previous pelvic radiation therapy\n* Inflammatory bowel disease","20 Years",{"count":60,"type":20},250,"2 Years","OBSERVATIONAL","Background: Colorectal cancer is the leading cause of cancer-related deaths in Taiwan, with rectal cancer accounting for approximately 27% of all cases. Total neoadjuvant therapy (TNT), which consists of chemotherapy and radiation therapy delivered before surgery, has become the standard of care for locally advanced rectal cancer. However, there is currently no reliable method for predicting the response to TNT or the occurrence of radiation proctitis, a common side effect of treatment.\n\nObjective: This study aims to evaluate the metabolomic profiles of individuals with locally advanced rectal cancer undergoing TNT and to identify a panel of metabolites that can predict treatment response and toxicities.\n\nMethods: A prospective cohort study will be conducted to enrol patients with locally advanced rectal cancer who are scheduled to receive TNT. Blood, urine, tissue, and faecal samples will be collected at baseline, during, and after chemoradiotherapy. Metabolomic profiling of the samples will be performed using liquid-chromatography mass spectrometry (LC-MS). Treatment response will be assessed based on clinical downstaging (defined as a decrease in tumour size and\u002For T and N stage after TNT) and pathological response, such as pathological complete response (pCR). Radiation proctitis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. PCA and PLSDA will be used to identify metabolites that are associated with treatment response and radiation proctitis. Receiver operating characteristic (ROC) curves will be used to assess the predictive performance of the identified metabolites. Univariate and multivariate logistic regression will be used to build models to predict treatment response and radiation proctitis.",[27],[66,67,68,69],"Rectal cancer","Total neoadjuvant therapy","Metabolomics","Radiation proctitis","2026-04-13",{"date":72,"type":42},"2026-04-15",{"date":74,"type":42},"2024-01-05",{"date":76,"type":20},"2033-12-12",{"name":78,"class":49},"Chang Gung Memorial Hospital",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":79},"100584993","latitude---lateral-lymph-node-attitude-study-100584993","NCT06896578","Latitude - Lateral Lymph Node Attitude Study","Lateral Lymph Nodes in Rectal Cancer Attitude Study","Latitude","Inclusion Criteria:\n\n* 18 years or older\n* written informed consent\n* adenocarcinoma verified tumour below ≤ 8 cm from anal verge measured by rectoscopy and\u002For MRI\n* clinical tumor (cT) stage cT3, cT4a or cT4b on MRI or\n* adenocarcinoma verified tumour at any height ≤ 15 cm from anal verge measured by rectoscopy and\u002For MRI regardless of T\u002FN stage with visible lateral lymph node (according to definition 2.4.2) on pre-therapeutic MRI or PET-CT\n\nExclusion Criteria:\n\n* Not biopsy confirmed rectal cancer (adenocarcinoma)\n* Recurrent rectal cancer\n* Age below 18\n* Participation in other trials in conflict with the protocol and end-points of the Latitude study\n* No informed consent",{"count":89,"type":20},1000,[23],"Patients with advanced rectal cancer can sometimes have suspected tumour affected lymph nodes outside the standard operating field. These patients often receive preoperative treatment before surgery. There is a lack of consensus on what to do if there is remaining suspicion of tumour affected lymph nodes after the preoperative treatment. Removal of the lymph nodes using a broader surgical field with dissection of the lateral side-wall is often suggested, but the oncologic outcome is uncertain, and so is the patient reported outcome in terms of side effects.\n\nThis study aims to study the surgical treatment of tumour affected lateral lymph nodes to understand what lymph nodes require removal, and what effect that will have on oncologic outcome and the patient's function and QoL.",[27],[94,95,96,97,98,99],"lateral lymph nodes","Quality of life","local recurrence","thrombosis","lymph oedema","lateral lymph node dissection","NOT_YET_RECRUITING","2025-08-07",{"date":103,"type":42},"2025-08-08",{"date":105,"type":20},"2025-09-15",{"date":107,"type":20},"2034-02-01",{"name":109,"class":49},"Sahlgrenska University Hospital",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":79},"100330841","total-mesorectal-excisiontme-with-lateral-lymph-node-dissection-versus-tme-after-neoadjuvant-chemo-radiotherapy-100330841","NCT03587480","Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy","Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy of Lower Rectal Cancer With Suspected Local Lymph Node Metastasis","TELEPHOME","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ\n2. Tumor is capable of performing radical recession\n3. No past history of chemotherapy, pelvic radiation of other cancers.\n4. Written informed consent\n5. Lower tumor margin is confirmed below the peritoneal reflection\n6. Clinical state T(1-3)N(1-2)M0 is confirmed by the multiple disciplines team(MDT) including surgeons,diagnostic radiologist,radiation oncologist and medical oncologists base on MRI and endorectal ultrasound -\n\nExclusion Criteria:\n\n1. Past history of other cancers\n2. Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP)\n3. Combine with inflammatory bowl disease(IBD)\n4. Recurrence tumor or invade other organs\n5. Combine with obstruction,perforation or bleeding which need emergency surgery.\n6. Local tumor invade the external sphincter, levator ani muscle or adjacent organs\n7. Participant join other clinical trials in 4 weeks.\n8. American Society of Anesthesiologists(ASA) ≥Ⅳ and\u002For Eastern Cooperative Oncology Group(ECOG) ≤2\n9. Pregnant or lactating patients\n10. Severity infection before operation\n11. Psychological disorder\n12. Severe dysfunction of organs or other contraindications\n13. Cardiac infarction within six months\n14. Severe pulmonary emphysema and pulmonary fibrosis\n15. Doctor's decision for exclusion\n16. Operative findings:\n\nTumor invade other organs Lower tumor margin is above the peritoneal reflection","75 Years",{"count":60,"type":20},[23],"Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis",[27],[124,125,126,127],"Low rectal cancer","Total Mesorectal Excision (TME)","neoadjuvant Chemo-radiotherapy (nCRT)","lateral lymph node dissection (LLND)","2022-11-22",{"date":130,"type":42},"2022-11-25",{"date":132,"type":42},"2018-12-17",{"date":134,"type":20},"2030-05-24",{"name":136,"class":49},"Sixth Affiliated Hospital, Sun Yat-sen University"]