Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-06 @ 11:54 AM
Study NCT ID:
NCT01615302
Status:
UNKNOWN
Last Update Posted:
2012-08-22
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of fistulas', 'timeFrame': 'Assessed up to 104 weeks after operation', 'description': 'The surgeon or docter in the outpatient clinic will decide if there is a recurrent fistula or not.\n\nIn case of doubt a MRI will be made.'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Assessed at 2 weeks after operation', 'description': 'Measured using the Visual Analogue Scale (VAS-score)'}, {'measure': 'Quality of Life', 'timeFrame': 'Assessed at 2 weeks after operation', 'description': 'Measured using the SF-36v2 questionnaire'}, {'measure': 'Incontinence', 'timeFrame': 'Assessed at 2 weeks after operation', 'description': 'Measured using the Vaizey score'}, {'measure': 'Pain', 'timeFrame': 'Assessed at 4 weeks after operation', 'description': 'Measured using the Visual Analogue Scale (VAS-score)'}, {'measure': 'Pain', 'timeFrame': 'Assessed at 16 weeks after operation', 'description': 'Measured using the Visual Analogue Scale (VAS-score)'}, {'measure': 'Pain', 'timeFrame': 'Assessed at 24 weeks after operation', 'description': 'Measured using the Visual Analogue Scale (VAS-score)'}, {'measure': 'Pain', 'timeFrame': 'Assessed at 52 weeks after operation', 'description': 'Measured using the Visual Analogue Scale (VAS-score)'}, {'measure': 'Pain', 'timeFrame': 'Assessed at 104 weeks after operation', 'description': 'Measured using the Visual Analogue Scale (VAS-score)'}, {'measure': 'Quality of life', 'timeFrame': 'Assessed at 4 weeks after operation', 'description': 'Measured using the SF-36v2 questionnaire'}, {'measure': 'Quality of Life', 'timeFrame': 'Assessed at 16 weeks after operation', 'description': 'Measured using the SF-36v2 questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'Assessed at 24 weeks after operation', 'description': 'Measured using the SF-36v2 questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'Assessed at 52 weeks after operation', 'description': 'Measured using the SF-36v2 questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'Assessed at 104 weeks after operation', 'description': 'Measured using the SF-36v2 questionnaire'}, {'measure': 'Incontinence', 'timeFrame': 'Assesed at 4 weeks after operation', 'description': 'Measured using the Vaizey score'}, {'measure': 'Incontinence', 'timeFrame': 'Assessed at 16 weeks after operation', 'description': 'Measured using the Vaizey score'}, {'measure': 'Incontinence', 'timeFrame': 'Assessed at 52 weeks after operation', 'description': 'Measured using the Vaizey score'}, {'measure': 'Incontinence', 'timeFrame': 'Assessed at 24 weeks after operation', 'description': 'Measured using the Vaizey score'}, {'measure': 'Incontinence', 'timeFrame': 'Assessed at 104 weeks after operation', 'description': 'Measured using the Vaizey score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rectal Fistula', 'Peri-anal Fistula', 'Platelet-Rich Plasma', 'Mucosa advancement flap'], 'conditions': ['Rectal Fistula']}, 'referencesModule': {'references': [{'pmid': '19575739', 'type': 'BACKGROUND', 'citation': 'van der Hagen SJ, Baeten CG, Soeters PB, van Gemert WG. Autologous platelet-derived growth factors (platelet-rich plasma) as an adjunct to mucosal advancement flap in high cryptoglandular perianal fistulae: a pilot study. Colorectal Dis. 2011 Feb;13(2):215-8. doi: 10.1111/j.1463-1318.2009.01991.x.'}, {'pmid': '24401885', 'type': 'DERIVED', 'citation': 'Gottgens KW, Vening W, van der Hagen SJ, van Gemert WG, Smeets RR, Stassen LP, Baeten CG, Breukink SO. Long-term results of mucosal advancement flap combined with platelet-rich plasma for high cryptoglandular perianal fistulas. Dis Colon Rectum. 2014 Feb;57(2):223-7. doi: 10.1097/DCR.0000000000000023.'}]}, 'descriptionModule': {'briefSummary': "Rationale:\n\nClosure of the internal opening is the most accepted standard procedure in the treatment of peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one out of the three patients mucosal flap repair fails. Possible causal factors are incomplete clearance of pus and debris, incomplete closure of the internal opening, inappropriate host response in patients with risk factors like smoking or diabetes. Platelet derived growth factors may facilitate closure of the internal opening, especially in patients with impaired wound healing.\n\nObjective:\n\nThe use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal advancement flap to achieve a better closure rate of complex peri-anal fistula's.\n\nStudy design:\n\nRandomized, multicenter trial.\n\nStudy population:\n\nPatients with complex cryptoglandular peri-anal fistula's.\n\nIntervention:\n\nInjection of PRP in the curretted fistula track under the mucosal flap.\n\nMain study parameters/endpoints:\n\n* Recurrence rate\n* Post-operative pain\n* Continence\n* Quality of life.\n\nNature and extent of the burden and risks associated with participation, group relatedness:\n\nBecause autologous blood is used, no extra risk are expected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Complex peri-anal fistula.\n* Able to understand informed consent.\n\nExclusion Criteria:\n\n* Pregnancy\n* Local malignancy\n* Crohn's disease or Ulcerative colitis\n* Traumatic or iatrogenic lesion\n* Thrombocytopenia\n* Splenomegaly\n* Bleeding disorders\n* Hematologic malignancies"}, 'identificationModule': {'nctId': 'NCT01615302', 'briefTitle': 'Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.', 'orgStudyIdInfo': {'id': 'METC 10-1-082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mucosa advancement flap', 'interventionNames': ['Procedure: Mucosa advancement flap']}, {'type': 'EXPERIMENTAL', 'label': 'Mucosa advancement flap + PRP', 'description': 'Platelet rich plasma added to the mucosa advancement flap', 'interventionNames': ['Procedure: Mucosa advancement flap', 'Other: Platelet rich plasma (PRP)']}], 'interventions': [{'name': 'Mucosa advancement flap', 'type': 'PROCEDURE', 'description': 'Mucosa advancement flap will be performed at the starting point of the fistula in the rectum', 'armGroupLabels': ['Mucosa advancement flap', 'Mucosa advancement flap + PRP']}, {'name': 'Platelet rich plasma (PRP)', 'type': 'OTHER', 'description': 'The PRP will be injected into the fistula, after the mucosa advancement flap was created.\n\nFor the PRP we will need to take 55 millilitres of blood of the patient. This blood will be centrifuged into PRP.', 'armGroupLabels': ['Mucosa advancement flap + PRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6419 PC', 'city': 'Heerlen', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wim G. v. Gemert, MD, PhD', 'role': 'CONTACT', 'email': 'wgt01@atriummc.nl', 'phone': '+31455766666'}, {'name': 'Wim G. van Gemert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Kevin W.A. Göttgens, MD', 'role': 'CONTACT', 'email': 'kevin.gottgens@mumc.nl', 'phone': '+31433876543'}, {'name': 'Stephanie O. Breukink, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kevin W.A. Göttgens, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6043 CV', 'city': 'Roermond', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jeroen Heemskerk, MD, PhD', 'role': 'CONTACT', 'email': 'j.heemskerk@lzr.nl', 'phone': '+31475382222'}, {'name': 'Jeroen Heemskerk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laurentius ziekenhuis', 'geoPoint': {'lat': 51.19417, 'lon': 5.9875}}, {'zip': '4819 EV', 'city': 'Breda', 'state': 'North Brabant', 'status': 'WITHDRAWN', 'country': 'Netherlands', 'facility': 'Amphia ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'J.P. de Zoete, MD, PhD', 'role': 'CONTACT', 'email': 'jean-paul.d.zoete@cze.nl', 'phone': '+31402399111'}, {'name': 'J.P. de Zoete, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Catharina ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '9501 HE', 'city': 'Stadskanaal', 'state': 'Provincie Groningen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Stephan J. van der Hagen, MD, PhD', 'role': 'CONTACT', 'email': 'sjvanderhagen@refaja.nl', 'phone': '+31599654654'}, {'name': 'Stephan J. van der Hagen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Refaja Ziekenhuis', 'geoPoint': {'lat': 52.98947, 'lon': 6.9504}}], 'centralContacts': [{'name': 'Kevin W.A. Göttgens, MD', 'role': 'CONTACT', 'email': 'kevin.gottgens@mumc.nl', 'phone': '+31433876543'}], 'overallOfficials': [{'name': 'Stephanie O. Breukink, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}, {'name': 'Cor G.M.I. Baeten, MD, PhD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biomet Nederland BV', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}