Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-01 @ 10:57 PM
Study NCT ID:
NCT02565667
Status:
UNKNOWN
Last Update Posted:
2016-03-25
First Post:
2015-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
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': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-24', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anastomotic leak rate', 'timeFrame': '30 days since the date of surgery', 'description': 'percentage of patients occuring anastomotic leak within 30 days since surgery'}], 'secondaryOutcomes': [{'measure': 'post-operative anal function', 'timeFrame': 'within one year since the date of surgery'}, {'measure': '30-day mortality rate', 'timeFrame': 'within 30 days since the date of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low rectal carcinoma', 'anastomosis', 'anterior rectal resection'], 'conditions': ['Rectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '25664712', 'type': 'BACKGROUND', 'citation': 'Midura EF, Hanseman D, Davis BR, Atkinson SJ, Abbott DE, Shah SA, Paquette IM. Risk factors and consequences of anastomotic leak after colectomy: a national analysis. Dis Colon Rectum. 2015 Mar;58(3):333-8. doi: 10.1097/DCR.0000000000000249.'}, {'pmid': '25619499', 'type': 'BACKGROUND', 'citation': 'Espin E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26.'}, {'pmid': '22968068', 'type': 'BACKGROUND', 'citation': 'Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.'}, {'pmid': '24070663', 'type': 'BACKGROUND', 'citation': 'Morse BC, Simpson JP, Jones YR, Johnson BL, Knott BM, Kotrady JA. Determination of independent predictive factors for anastomotic leak: analysis of 682 intestinal anastomoses. Am J Surg. 2013 Dec;206(6):950-5; discussion 955-6. doi: 10.1016/j.amjsurg.2013.07.017. Epub 2013 Sep 24.'}, {'pmid': '21394013', 'type': 'BACKGROUND', 'citation': 'Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.'}, {'pmid': '10789750', 'type': 'BACKGROUND', 'citation': 'Roumen RM, Rahusen FT, Wijnen MH, Croiset van Uchelen FA. "Dog ear" formation after double-stapled low anterior resection as a risk factor for anastomotic disruption. Dis Colon Rectum. 2000 Apr;43(4):522-5. doi: 10.1007/BF02237198.'}]}, 'descriptionModule': {'briefSummary': 'The most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.', 'detailedDescription': 'About 5-10% of patients receiving low rectal resection using traditional anastomosis occurred anastomotic leak, risk factors for which included patient related (age, gender, tumor distance from the anal verge), hypoproteinemia, diabetes mellitus, etc), procedure related (emergency) and technical related (one stapler, double stapler or handsewn).\n\nAnastomotic leak caused prolonged hospital stay, delayed post-operative adjuvant radiochemotherapy and need of stoma in some cases. Besides, anastomotic leak was reported to be associated with increased local recurrence rate. Thus, it\'s of great importance to develop new surgical devices to prevent "dog ear" problem and reduce the anastomotic leak rate.\n\nDouble stapled pursestring anastomosis was the one of the most widely used methods in lower rectal resection. One major problem of this procedure was creating one or double side "dog ear" phenomenon (Dis Colon Rectum. 2000 Apr;43(4):522-5. Fig 1). This weak spot was theoretically responsible for post-operative anastomotic leak as demonstrated by animal experiments and clinical practice.\n\nIn this clinical trial, we used a transanal double purse-string rectal anastomosis preformed with KOL stapler for lower rectal resection. This procedure would resolve the dog ear problem through circular anastomosis taking care that the anastomotic site contained only gut tissues without any staples. We aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathological confirmed rectal adenocarcinoma\n2. less than 10 cm of distal tumor margin from the anal edge\n3. less than 4 cm of maximum tumor diameter and less than 1/2 of circumference diameter\n4. tumor stage earlier than cT1-3N0M0 before surgery or that following neoadjuvant radiochemotherapy\n5. normal defecation function (Wexner score \\< 4)\n6. open or laparoscopic operation\n\nExclusion Criteria:\n\n1. recurrent cases\n2. emergency including obstruction, bleeding or perforation\n3. severe abdominal adhesions\n4. severe malnutrition can not be improved before surgery\n5. can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney\n6. refractory hypoproteinemia or diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02565667', 'briefTitle': 'A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective Randomized Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler', 'orgStudyIdInfo': {'id': 'FudanKOL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KOL group', 'description': 'KOL stapler was used for rectal anastomosis', 'interventionNames': ['Device: KOL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional stapler group', 'description': 'traditional stapler was used for rectal anastomosis', 'interventionNames': ['Device: traditional staple']}], 'interventions': [{'name': 'KOL', 'type': 'DEVICE', 'description': 'KOL staple was used for rectal anastomosis', 'armGroupLabels': ['KOL group']}, {'name': 'traditional staple', 'type': 'DEVICE', 'description': 'traditional staple was used for rectal anastomosis', 'armGroupLabels': ['traditional stapler group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'SANJUN CAI, DOCTOR', 'role': 'CONTACT', 'email': 'caisanjun@gmail.com', 'phone': '02164175590', 'phoneExt': '1108'}, {'name': 'XINXIANG LI, DOCTOR', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'YIWEI LI, DOCTOR', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Li Xin-Xiang, M.D & Ph.D.', 'role': 'CONTACT', 'email': 'lxx1149@163.com', 'phone': '+86-18017312900'}, {'name': 'Li Yi-Wei, M.D & Ph.D.', 'role': 'CONTACT', 'email': 'liyiwei1981@gmail.com', 'phone': '+86-18121299437'}], 'overallOfficials': [{'name': 'Li Xin-Xiang, M.D & Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Cancer Center, Fudan University, #270 Dong An Road, Shanghai, 200030'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of colorectal surgery', 'investigatorFullName': 'LI XIN-XIANG', 'investigatorAffiliation': 'Fudan University'}}}}