Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-08 @ 8:40 PM
Study NCT ID:
NCT02585167
Status:
TERMINATED
Last Update Posted:
2021-05-14
First Post:
2015-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Treatment of Complex Anal Fistulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'The significantly higher recurrence rate in the intervention group led to a serious ethical consideration of a premature closing of the study which was decided due to safety and benefit concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2015-10-21', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recurrence rate of perianal fistula', 'timeFrame': '6 months', 'description': 'A comparison on the rate of recurrence of anal fistula in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.'}], 'secondaryOutcomes': [{'measure': 'changes in quality of life score', 'timeFrame': 'baseline and 6 months', 'description': 'A comparison on changes in quality of life, using The Short Form (36) Health Survey in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.'}, {'measure': 'changes in fecal incontinence score', 'timeFrame': 'baseline and 6 months', 'description': 'A comparison on changes in Wexner score in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.'}, {'measure': 'changes in manometric study', 'timeFrame': 'baseline and 6 months', 'description': 'A comparison on changes in manometric study(including maximum resting pressure, maximum squeeze pressure) in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['VAAFT', 'anal fistula', 'sphincter reconstruction'], 'conditions': ['Anal Fistula']}, 'referencesModule': {'references': [{'pmid': '9068549', 'type': 'BACKGROUND', 'citation': 'Barwood N, Clarke G, Levitt S, Levitt M. Fistula-in-ano: a prospective study of 107 patients. Aust N Z J Surg. 1997 Feb-Mar;67(2-3):98-102. doi: 10.1111/j.1445-2197.1997.tb01911.x.'}, {'pmid': '22469475', 'type': 'BACKGROUND', 'citation': 'Nicholls J. Anal fistula. Colorectal Dis. 2012 May;14(5):535. doi: 10.1111/j.1463-1318.2012.03025.x. No abstract available.'}, {'pmid': '26050835', 'type': 'BACKGROUND', 'citation': 'Lundby L, Hagen K, Christensen P, Buntzen S, Thorlacius-Ussing O, Andersen J, Krupa M, Qvist N. Treatment of non-IBD anal fistula. Dan Med J. 2015 May;62(5):C5088.'}, {'pmid': '22067173', 'type': 'BACKGROUND', 'citation': 'Steele SR, Kumar R, Feingold DL, Rafferty JL, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of perianal abscess and fistula-in-ano. Dis Colon Rectum. 2011 Dec;54(12):1465-74. doi: 10.1097/DCR.0b013e31823122b3. No abstract available.'}, {'pmid': '21975159', 'type': 'BACKGROUND', 'citation': "Hvas CL, Dahlerup JF, Jacobsen BA, Ljungmann K, Qvist N, Staun M, Tottrup A. Diagnosis and treatment of fistulising Crohn's disease. Dan Med Bull. 2011 Oct;58(10):C4338."}, {'pmid': '23373352', 'type': 'BACKGROUND', 'citation': 'Nicholls RJ. Fistula in ano: an overview. Acta Chir Iugosl. 2012;59(2):9-13. doi: 10.2298/aci1202009n.'}, {'pmid': '12380393', 'type': 'BACKGROUND', 'citation': 'Christiansen J, Moesgaard FA. [Treatment of anal fistulas]. Ugeskr Laeger. 2002 Sep 23;164(39):4519-21. No abstract available. Danish.'}, {'pmid': '19486093', 'type': 'BACKGROUND', 'citation': 'Bokhari S, Lindsey I. Incontinence following sphincter division for treatment of anal fistula. Colorectal Dis. 2010 Jul;12(7 Online):e135-9. doi: 10.1111/j.1463-1318.2009.01872.x. Epub 2009 Apr 10.'}, {'pmid': '23303152', 'type': 'BACKGROUND', 'citation': 'Ratto C, Litta F, Parello A, Zaccone G, Donisi L, De Simone V. Fistulotomy with end-to-end primary sphincteroplasty for anal fistula: results from a prospective study. Dis Colon Rectum. 2013 Feb;56(2):226-33. doi: 10.1097/DCR.0b013e31827aab72.'}, {'pmid': '19604292', 'type': 'BACKGROUND', 'citation': 'Roig JV, Garcia-Armengol J, Jordan JC, Moro D, Garcia-Granero E, Alos R. Fistulectomy and sphincteric reconstruction for complex cryptoglandular fistulas. Colorectal Dis. 2010 Jul;12(7 Online):e145-52. doi: 10.1111/j.1463-1318.2009.02002.x. Epub 2009 Jul 9.'}, {'pmid': '16769272', 'type': 'BACKGROUND', 'citation': 'Perez F, Arroyo A, Serrano P, Sanchez A, Candela F, Perez MT, Calpena R. Randomized clinical and manometric study of advancement flap versus fistulotomy with sphincter reconstruction in the management of complex fistula-in-ano. Am J Surg. 2006 Jul;192(1):34-40. doi: 10.1016/j.amjsurg.2006.01.028.'}, {'pmid': '23577759', 'type': 'BACKGROUND', 'citation': 'Roig, Garcia-Armengol, Jordan, Alos, Solana. Immediate reconstruction of the anal sphincter after fistulectomy in the management of complex anal fistulas. Colorectal Dis. 1999 May;1(3):137-40. doi: 10.1046/j.1463-1318.1999.00021.x.'}, {'pmid': '19459524', 'type': 'BACKGROUND', 'citation': 'Jivapaisarnpong P. Core out fistulectomy, anal sphincter reconstruction and primary repair of internal opening in the treatment of complex anal fistula. J Med Assoc Thai. 2009 May;92(5):638-42.'}, {'pmid': '22706126', 'type': 'BACKGROUND', 'citation': 'Tobisch A, Stelzner S, Hellmich G, Jackisch T, Witzigmann H. Total fistulectomy with simple closure of the internal opening in the management of complex cryptoglandular fistulas: long-term results and functional outcome. Dis Colon Rectum. 2012 Jul;55(7):750-5. doi: 10.1097/DCR.0b013e3182569b29.'}, {'pmid': '22002535', 'type': 'BACKGROUND', 'citation': 'Meinero P, Mori L. Video-assisted anal fistula treatment (VAAFT): a novel sphincter-saving procedure for treating complex anal fistulas. Tech Coloproctol. 2011 Dec;15(4):417-22. doi: 10.1007/s10151-011-0769-2. Epub 2011 Oct 15.'}, {'pmid': '24509459', 'type': 'BACKGROUND', 'citation': 'Meinero P, Mori L, Gasloli G. Video-assisted anal fistula treatment: a new concept of treating anal fistulas. Dis Colon Rectum. 2014 Mar;57(3):354-9. doi: 10.1097/DCR.0000000000000082.'}, {'pmid': '23179892', 'type': 'BACKGROUND', 'citation': "Schwandner O. Video-assisted anal fistula treatment (VAAFT) combined with advancement flap repair in Crohn's disease. Tech Coloproctol. 2013 Apr;17(2):221-5. doi: 10.1007/s10151-012-0921-7. Epub 2012 Nov 23."}, {'pmid': '22016156', 'type': 'BACKGROUND', 'citation': 'Zbar AP. "Video-assisted anal fistula treatment (VAAFT): a novel sphincter-saving procedure to repair complex anal fistulas" by Piercarlo Meinero and Lorenzo Mori. Tech Coloproctol. 2011 Dec;15(4):423-4. doi: 10.1007/s10151-011-0771-8. No abstract available.'}, {'pmid': '16317550', 'type': 'BACKGROUND', 'citation': 'Quah HM, Tang CL, Eu KW, Chan SY, Samuel M. Meta-analysis of randomized clinical trials comparing drainage alone vs primary sphincter-cutting procedures for anorectal abscess-fistula. Int J Colorectal Dis. 2006 Sep;21(6):602-9. doi: 10.1007/s00384-005-0060-y. Epub 2005 Nov 30.'}, {'pmid': '22964203', 'type': 'BACKGROUND', 'citation': 'Grucela A, Gurland B, Kiran RP. Functional outcomes and quality of life after anorectal surgery. Am Surg. 2012 Sep;78(9):952-6.'}, {'pmid': '17680311', 'type': 'BACKGROUND', 'citation': "Kasparek MS, Glatzle J, Temeltcheva T, Mueller MH, Koenigsrainer A, Kreis ME. Long-term quality of life in patients with Crohn's disease and perianal fistulas: influence of fecal diversion. Dis Colon Rectum. 2007 Dec;50(12):2067-74. doi: 10.1007/s10350-007-9006-5."}, {'pmid': '22956209', 'type': 'BACKGROUND', 'citation': "Riss S, Schwameis K, Mittlbock M, Pones M, Vogelsang H, Reinisch W, Riedl M, Stift A. Sexual function and quality of life after surgical treatment for anal fistulas in Crohn's disease. Tech Coloproctol. 2013 Feb;17(1):89-94. doi: 10.1007/s10151-012-0890-x. Epub 2012 Sep 6."}, {'pmid': '19617761', 'type': 'BACKGROUND', 'citation': 'Roig JV, Jordan J, Garcia-Armengol J, Esclapez P, Solana A. Changes in anorectal morphologic and functional parameters after fistula-in-ano surgery. Dis Colon Rectum. 2009 Aug;52(8):1462-9. doi: 10.1007/DCR.0b013e3181a80e24.'}, {'pmid': '11357023', 'type': 'BACKGROUND', 'citation': 'Ha HT, Fleshman JW, Smith M, Read TE, Kodner IJ, Birnbaum EH. Manometric squeeze pressure difference parallels functional outcome after overlapping sphincter reconstruction. Dis Colon Rectum. 2001 May;44(5):655-60. doi: 10.1007/BF02234561.'}, {'pmid': '9876082', 'type': 'BACKGROUND', 'citation': 'Sailer M, Bussen D, Debus ES, Fuchs KH, Thiede A. Quality of life in patients with benign anorectal disorders. Br J Surg. 1998 Dec;85(12):1716-9. doi: 10.1046/j.1365-2168.1998.00958.x.'}, {'pmid': '1267867', 'type': 'BACKGROUND', 'citation': 'Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-ano. Br J Surg. 1976 Jan;63(1):1-12. doi: 10.1002/bjs.1800630102.'}, {'pmid': '34611700', 'type': 'DERIVED', 'citation': 'Sorensen KM, Moller S, Qvist N. Video-assisted anal fistula treatment versus fistulectomy and sphincter repair in the treatment of high cryptoglandular anal fistula: a randomized clinical study. BJS Open. 2021 Sep 6;5(5):zrab097. doi: 10.1093/bjsopen/zrab097.'}], 'seeAlsoLinks': [{'url': 'http://open.rsyd.dk/OpenProjects/da/openProject.jsp?openNo=145', 'label': 'OPEN homepage'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.', 'detailedDescription': 'The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with complex transsphincteric anal fistulas \\>18 yrs old.\n\nExclusion Criteria:\n\n* Crohns fistulas\n* Signs of suppuration or/and branching.\n* Malignancy within 5 yrs.\n* Previous radiotherapy of the abdomen and pelvis.\n* Current Immune- suppressive treatment.'}, 'identificationModule': {'nctId': 'NCT02585167', 'acronym': 'VAAFT', 'briefTitle': 'Endoscopic Treatment of Complex Anal Fistulas', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Endoscopic or Surgical Treatment of Complex Perianal Fistula. A Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'S-20150053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Operation', 'description': 'the fistula will be excised after dividing the sphincter and primary reconstruction\n\n.', 'interventionNames': ['Procedure: operation']}, {'type': 'EXPERIMENTAL', 'label': 'VAAFT', 'description': 'the fistula tract will be visualized by scope, closing the internal opening with absorbable sutures.', 'interventionNames': ['Device: VAAFT']}], 'interventions': [{'name': 'operation', 'type': 'PROCEDURE', 'otherNames': ['Fistulectomy and primary sphincter reconstruction'], 'description': 'the fistula will be excised after dividing the sphincter and primary reconstruction will be performed with absorbable sutures, closing the internal opening and leaving the external opening unclosed for drainage.', 'armGroupLabels': ['Operation']}, {'name': 'VAAFT', 'type': 'DEVICE', 'description': 'Karl Storz Video Equipment is used. The fistula tract will be visualized from the external to the internal opening, closing the internal opening with absorbable sutures, then brushing and cauterization of the tract(s) leaving the external opening unclosed for drainage.', 'armGroupLabels': ['VAAFT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'læge', 'investigatorFullName': 'Karam Matlub Sørensen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}