Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-24 @ 4:36 AM
Study NCT ID:
NCT02550769
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2015-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NOTES-TME Versus L-LAR in Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2015-08-31', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.', 'timeFrame': '30 days', 'description': 'Evaluate surgical complications 30 days after surgery.'}, {'measure': 'Evaluate the effectiveness of the T-TME versus L-LAR with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR-30 score in patients with rectal cancer.', 'timeFrame': '6 months', 'description': 'Evaluate functional results 6 months after ileostomy closure.'}, {'measure': 'Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.', 'timeFrame': '6 months', 'description': 'Evaluate functional results 6 months after ileostomy closure.'}, {'measure': 'Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.', 'timeFrame': '6 months', 'description': 'Evaluate functional results 6 months after ileostomy closure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transanal NOTES', 'Transanal TME', 'Laparoscopic Low Anterior Resection', 'Surgery'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '25814073', 'type': 'BACKGROUND', 'citation': 'Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.'}, {'pmid': '24576748', 'type': 'BACKGROUND', 'citation': 'Serra-Aracil X. [Transanal total mesorectal excision]. Cir Esp. 2014 Apr;92(4):221-2. doi: 10.1016/j.ciresp.2014.01.002. Epub 2014 Feb 24. No abstract available. Spanish.'}, {'pmid': '36224406', 'type': 'DERIVED', 'citation': 'Serra-Aracil X, Zarate A, Bargallo J, Gonzalez A, Serracant A, Roura J, Delgado S, Mora-Lopez L; Ta-LaTME study Group. Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial. Br J Surg. 2023 Jan 10;110(2):150-158. doi: 10.1093/bjs/znac324.'}, {'pmid': '29546560', 'type': 'DERIVED', 'citation': 'Serra-Aracil X, Zarate A, Mora L, Serra-Pla S, Pallisera A, Bonfill J, Bargallo J, Pando A, Delgado S, Balleteros E, Pericay C. Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer. Int J Colorectal Dis. 2018 May;33(5):649-655. doi: 10.1007/s00384-018-2996-8. Epub 2018 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.\n\nMAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.\n\nMETHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.', 'detailedDescription': 'INTRODUCTION: The laparoscopic total mesorectal excision (TME) has provided better patient recovery with less morbidity and shorter hospital stay compared with open surgery. However in laparoscopic low rectal surgery, overall conversion to open surgery is around 20%. Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.\n\nMAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.\n\nMETHODOLOGY: A prospective multicenter randomized controlled study of patients diagnosed with adenocarcinoma of the rectum that after inclusion and exclusion criteria, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The other variables studied were: demographic, surgical, pathological, 30-day morbidity and mortality, quality of life and oncologic results. The sample calculation is 53 patients per group. With an estimated loss of 10%, the final number will be 116 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.\n* Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.\n* Adenocarcinoma of low or moderate differentiation\n* ASA I, II, III.\n\nExclusion Criteria:\n\n* Do not sign informed consent\n* Pregnant patients\n* Liver cirrhosis\n* Undifferentiated adenocarcinoma.\n* cT4\n* Metastatic disease (M1)\n* chronic renal failure on dialysis\n* ASA IV\n* BMI \\<18 and\\> 35 kg / m2'}, 'identificationModule': {'nctId': 'NCT02550769', 'acronym': 'NOTESvsL-LAR', 'briefTitle': 'Study of NOTES-TME Versus L-LAR in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer', 'orgStudyIdInfo': {'id': 'NOTES-LRAB_TAU-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRANSANAL TOTAL MESORECTAL EXCISION', 'description': 'Transanal approach of total mesorectal excision.', 'interventionNames': ['Procedure: TRANSANAL TOTAL MESORECTAL EXCISION']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic-LAR', 'description': 'Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer', 'interventionNames': ['Procedure: Laparoscopic-LAR']}], 'interventions': [{'name': 'TRANSANAL TOTAL MESORECTAL EXCISION', 'type': 'PROCEDURE', 'description': 'The technique begins with the TEO equipment and a purse string 1 cm distal to the tumor. The dissection progresses in the posterior part until the laparoscopic TME field is reached. After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope. In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus. The stapler is inserted. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip. Then the stapler are joined to perform the anastomosis and a loop ileostomy is placed in the right flank.', 'armGroupLabels': ['TRANSANAL TOTAL MESORECTAL EXCISION']}, {'name': 'Laparoscopic-LAR', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopic Low Anterior Resecion of the rectum'], 'description': 'Standard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis', 'armGroupLabels': ['Laparoscopic-LAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc Tauli University Hospital', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Serra-Aracil Xavier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporacio Parc Tauli. Parc Tauli University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Xavier Serra-Aracil', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}