Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-04 @ 5:18 AM
Study NCT ID:
NCT02419534
Status:
UNKNOWN
Last Update Posted:
2016-03-01
First Post:
2015-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatrics Anal Fissures Treatment With Polyethylene Glycol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005401', 'term': 'Fissure in Ano'}], 'ancestors': [{'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D004110', 'term': 'Diltiazem'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-27', 'studyFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cases with healed anal fissure as detected by clinical physical exam', 'timeFrame': 'up to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Number cases with painless bowel movement detected during clinical visits or phone interviews', 'timeFrame': 'at 2,4 and 8 weeks'}, {'measure': 'Number of individuals with minimal or no straining during bowel movement detected during clinical visits or phone interviews', 'timeFrame': 'at 2, 4, and 8 weeks'}, {'measure': 'Number of cases that are passing soft bowel movements detected during clinical visits or phone interviews', 'timeFrame': 'at 2, 4, and 8 weeks'}, {'measure': 'Number of cases who are passing > 3 watery bowel movement (Diarrhea) detected during clinical visits or phone interviews', 'timeFrame': 'at 2, 4, and 8 weeks'}, {'measure': 'Compliance (number of cases who are taking the PEG and/or Diltiazem Ointment) as detected during clinical visits or phone interviews', 'timeFrame': '2, 4, and 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatric, fissure in ano'], 'conditions': ['Fissure in Ano']}, 'referencesModule': {'references': [{'pmid': '21382575', 'type': 'RESULT', 'citation': 'Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.'}, {'pmid': '12194122', 'type': 'RESULT', 'citation': 'Sonmez K, Demirogullari B, Ekingen G, Turkyilmaz Z, Karabulut R, Basaklar AC, Kale N. Randomized, placebo-controlled treatment of anal fissure by lidocaine, EMLA, and GTN in children. J Pediatr Surg. 2002 Sep;37(9):1313-6. doi: 10.1053/jpsu.2002.34997.'}, {'pmid': '8181401', 'type': 'RESULT', 'citation': 'Farouk R, Duthie GS, MacGregor AB, Bartolo DC. Sustained internal sphincter hypertonia in patients with chronic anal fissure. Dis Colon Rectum. 1994 May;37(5):424-9. doi: 10.1007/BF02076185.'}, {'pmid': '21160880', 'type': 'RESULT', 'citation': 'Poh A, Tan KY, Seow-Choen F. Innovations in chronic anal fissure treatment: A systematic review. World J Gastrointest Surg. 2010 Jul 27;2(7):231-41. doi: 10.4240/wjgs.v2.i7.231.'}, {'pmid': '8026232', 'type': 'RESULT', 'citation': 'Schouten WR, Briel JW, Auwerda JJ. Relationship between anal pressure and anodermal blood flow. The vascular pathogenesis of anal fissures. Dis Colon Rectum. 1994 Jul;37(7):664-9. doi: 10.1007/BF02054409.'}, {'pmid': '3011180', 'type': 'RESULT', 'citation': 'Jensen SL. Treatment of first episodes of acute anal fissure: prospective randomised study of lignocaine ointment versus hydrocortisone ointment or warm sitz baths plus bran. Br Med J (Clin Res Ed). 1986 May 3;292(6529):1167-9. doi: 10.1136/bmj.292.6529.1167.'}, {'pmid': '20628272', 'type': 'RESULT', 'citation': 'Perry WB, Dykes SL, Buie WD, Rafferty JF; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of anal fissures (3rd revision). Dis Colon Rectum. 2010 Aug;53(8):1110-5. doi: 10.1007/DCR.0b013e3181e23dfe. No abstract available.'}, {'pmid': '21685792', 'type': 'RESULT', 'citation': 'Samim M, Twigt B, Stoker L, Pronk A. Topical diltiazem cream versus botulinum toxin a for the treatment of chronic anal fissure: a double-blind randomized clinical trial. Ann Surg. 2012 Jan;255(1):18-22. doi: 10.1097/SLA.0b013e318225178a.'}, {'pmid': '23402088', 'type': 'RESULT', 'citation': 'Ala S, Saeedi M, Hadianamrei R, Ghorbanian A. Topical diltiazem vs. topical glyceril trinitrate in the treatment of chronic anal fissure: a prospective, randomized, double-blind trial. Acta Gastroenterol Belg. 2012 Dec;75(4):438-42.'}, {'pmid': '22212494', 'type': 'RESULT', 'citation': 'Cevik M, Boleken ME, Koruk I, Ocal S, Balcioglu ME, Aydinoglu A, Karadag CA. A prospective, randomized, double-blind study comparing the efficacy of diltiazem, glyceryl trinitrate, and lidocaine for the treatment of anal fissure in children. Pediatr Surg Int. 2012 Apr;28(4):411-6. doi: 10.1007/s00383-011-3048-4. Epub 2012 Jan 3.'}, {'pmid': '11668104', 'type': 'RESULT', 'citation': 'Kenny SE, Irvine T, Driver CP, Nunn AT, Losty PD, Jones MO, Turnock RR, Lamont GL, Lloyd DA. Double blind randomised controlled trial of topical glyceryl trinitrate in anal fissure. Arch Dis Child. 2001 Nov;85(5):404-7. doi: 10.1136/adc.85.5.404.'}, {'pmid': '10626860', 'type': 'RESULT', 'citation': 'Tander B, Guven A, Demirbag S, Ozkan Y, Ozturk H, Cetinkursun S. A prospective, randomized, double-blind, placebo-controlled trial of glyceryl-trinitrate ointment in the treatment of children with anal fissure. J Pediatr Surg. 1999 Dec;34(12):1810-2. doi: 10.1016/s0022-3468(99)90318-4.'}, {'pmid': '22336789', 'type': 'RESULT', 'citation': 'Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.'}, {'pmid': '12041718', 'type': 'RESULT', 'citation': 'Gremse DA, Hixon J, Crutchfield A. Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children. Clin Pediatr (Phila). 2002 May;41(4):225-9. doi: 10.1177/000992280204100405.'}, {'pmid': '16254521', 'type': 'RESULT', 'citation': 'Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoit S, Benssoussan A, Boussioux JL, Boyer P, Brunet E, Delorme J, Francois-Cecchin S, Gottrand F, Grassart M, Hadji S, Kalidjian A, Languepin J, Leissler C, Lejay D, Livon D, Lopez JP, Mougenot JF, Risse JC, Rizk C, Roumaneix D, Schirrer J, Thoron B, Kalach N. Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):625-33. doi: 10.1097/01.mpg.0000181188.01887.78.'}, {'pmid': '15479678', 'type': 'RESULT', 'citation': 'Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620.'}, {'pmid': '11052511', 'type': 'RESULT', 'citation': 'Carapeti EA, Kamm MA, Phillips RK. Topical diltiazem and bethanechol decrease anal sphincter pressure and heal anal fissures without side effects. Dis Colon Rectum. 2000 Oct;43(10):1359-62. doi: 10.1007/BF02236630.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate whether effectively treating anal fissure-associated constipation using oral PEG alone can eliminate the inconvenience of add topical agent such as DTZ. As previous studies have shown the topical agent are more effective in treating anal fissure when combined with less effective laxatives', 'detailedDescription': 'Anal fissure (AF) is common among children attending pediatric and surgery clinics and is frequently associated with painful defecation, stool withholding and constipation which affect 1%-30% of the pediatric population. Constipated children consume low fiber diets, come from lower socioeconomic families and tend to be obese. The reason why anal fissure develops is still largely unclear, however the pathogenesis points to an initial anal trauma cause by the hard stool leading to anal sphincter hypertonia or spasm which cause local ischemia and non-healing ulcer. It is not clear why the posterior anal canal is the most affected part by the local anal ischemia.\n\nCurrent medical therapy for chronic anal fissure focuses on alleviating the two main pathologies by using anal sphincter relaxing topical ointments and laxative to treat associated constipation. The classical text book described treatment of AF focus on increasing fiber intake to treat the underlying constipation. Jensen et al, has found that treating the first episode of anal fissure with bran is more effective than local anesthetic or steroids. The American Society of Colon and Rectal Surgeons practice parameters suggest that increase in fluid and fiber ingestion, use of sitz baths, and if necessary use of stool softeners are safe have few side effects and should be the initial therapy for all patients with anal fissure.\n\nThere have been many recent randomized trials describing the effectiveness of Nitroglycerin (NTG), Botulinum toxin injection or the topical calcium channel blockers such as Diltiazem (DTZ) in adult and pediatric. A systematic review of the available randomized trials of these agents has shown that topical agents are marginally better than placebo \\[15\\]. Furthermore, in most trials that have demonstrated the effectiveness of topical agents laxatives usage was either not well controlled or lactulose was the main agent used. In children, many recent randomized trials have demonstrated the superior effectiveness of PEG over lactulose consequently; we think that treating AF with PEG is likely to improve the success rate and lead to persistent log-term fissure healing. Most adults and pediatric RCTs that have demonstrated the effectiveness of topical agents in healing AF, have focused on comparing various topical agents to placebo in treating AF, however the effectiveness in comparison to placebo has never been demonstrated in patients how are placed on more effective laxative such as PEG. We hypothesize that replacing lactulose with a more effective laxative such PEG as a sole agent to treat AF can eliminate the effectiveness and therefore the need to add topical sphincter relaxing agent such DTZ or NTG. Laxative-only treatment is likely to be more convenient and more cost-effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Painful defecation with visible anal fissure\n2. Symptoms for 2 weeks\n3. Children less than 14 years of age\n\nExclusion Criteria:\n\n1. Previous surgeries\n2. Chronic illness affecting the rectum or perianal area\n3. Refuse to participate'}, 'identificationModule': {'nctId': 'NCT02419534', 'briefTitle': 'Pediatrics Anal Fissures Treatment With Polyethylene Glycol', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Randomized Controlled Trial Comparing the Efficacy of Polyethylene Glycol Alone and Polyethylene Glycol Combined With Topical Diltiazem in Treating Anal fissure in Children', 'orgStudyIdInfo': {'id': '14/4293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Polyethylene glycol', 'description': 'In our study parents will be asked to start at 1g per day if they are less than 1 year of age and 2g per day in divided doses if they are older and will be asked to titrate the does according to the response up to the a maximum does of .5g/kg/day. In titrating the dose parent will be asked to increase the dose every 2 days until the child pass one normal BM per day without significant efforts. They should titrate down or hold treatment if the child developed lose BM or diarrhea. Caregiver will be asked to use placebo ointment by applying 5mm on fingertip to the anal verge area twice a day for the duration of the study.', 'interventionNames': ['Drug: Polyethylene glycol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polyethylene glycol with Diltiazem', 'description': 'Parents will be instructed to apply 5 mm of ointment on a fingertip at the anal verge twice daily for the duration of the study', 'interventionNames': ['Drug: Polyethylene glycol with Diltiazem']}], 'interventions': [{'name': 'Polyethylene glycol', 'type': 'DRUG', 'otherNames': ['Movicol'], 'description': 'Laxative to treat constipation', 'armGroupLabels': ['Polyethylene glycol']}, {'name': 'Polyethylene glycol with Diltiazem', 'type': 'DRUG', 'otherNames': ['Movicol + Diltiazem'], 'description': 'Laxative and topical calcium channel blocker', 'armGroupLabels': ['Polyethylene glycol with Diltiazem']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'state': 'Nejd Province - Central', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Ayman Al-Jazaeri', 'role': 'CONTACT', 'phone': '(966)-5-65994455'}], 'facility': 'College of medicine, king saud university', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Ayman Al-Jazaeri, MD', 'role': 'CONTACT', 'email': 'aljazaeri@yahoo.com', 'phone': '(966)-5-65994455'}, {'name': 'Al-Jazaeri, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ayman Al-Jazaeri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor & Consultant of Pediatric,Medical College, King Saud University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor & Consultant of Pediatric surgery', 'investigatorFullName': 'Ayman Aljazaeri', 'investigatorAffiliation': 'King Saud University'}}}}