Pediatrics Anal Fissures Treatment With Polyethylene Glycol

NCT02419534 | Unknown Phase 4

• 1 other identifier: 14/4293
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fissure in Ano

Keywords

Pediatric, fissure in ano

Outcome Measures

Primary Outcomes (1)

• Number of cases with healed anal fissure as detected by clinical physical exam

  up to 8 weeks

Secondary Outcomes (5)

• Number cases with painless bowel movement detected during clinical visits or phone interviews

  at 2,4 and 8 weeks

• Number of individuals with minimal or no straining during bowel movement detected during clinical visits or phone interviews

  at 2, 4, and 8 weeks

• Number of cases that are passing soft bowel movements detected during clinical visits or phone interviews

  at 2, 4, and 8 weeks

• Number of cases who are passing > 3 watery bowel movement (Diarrhea) detected during clinical visits or phone interviews

  at 2, 4, and 8 weeks

• Compliance (number of cases who are taking the PEG and/or Diltiazem Ointment) as detected during clinical visits or phone interviews

  2, 4, and 8 weeks

Study Arms (2)

Polyethylene glycol

ACTIVE COMPARATOR

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.

Drug: Polyethylene glycol

Polyethylene glycol with Diltiazem

ACTIVE COMPARATOR

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

Drug: Polyethylene glycol with Diltiazem

Interventions

Polyethylene glycol DRUG

Laxative to treat constipation

Also known as: Movicol

Polyethylene glycol

Polyethylene glycol with Diltiazem DRUG

Laxative and topical calcium channel blocker

Also known as: Movicol + Diltiazem

Polyethylene glycol with Diltiazem

Eligibility Criteria

• Age: 1 Minute - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Painful defecation with visible anal fissure
• Symptoms for 2 weeks
• Children less than 14 years of age

You may not qualify if:

• Previous surgeries
• Chronic illness affecting the rectum or perianal area
• Refuse to participate

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

College of medicine, king saud university

Riyadh, Nejd Province - Central, Saudi Arabia

RECRUITING

Related Publications (17)

• 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: 21382575 RESULT

• 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: 12194122 RESULT

• 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: 8181401 RESULT

• 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: 21160880 RESULT

• 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: 8026232 RESULT

• 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: 3011180 RESULT

• 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: 20628272 RESULT

• 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: 21685792 RESULT

• 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: 23402088 RESULT

• 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: 22212494 RESULT

• 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: 11668104 RESULT

• 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: 10626860 RESULT

• 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: 22336789 RESULT

• 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: 12041718 RESULT

• 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: 16254521 RESULT

• 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: 15479678 RESULT

• 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.

  PMID: 11052511 RESULT

MeSH Terms

Conditions

Fissure in Ano

Interventions

Polyethylene Glycols; Diltiazem

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ayman Al-Jazaeri

  Associate Professor & Consultant of Pediatric,Medical College, King Saud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman Al-Jazaeri, MD

CONTACT

(966)-5-65994455; aljazaeri@yahoo.com

Al-Jazaeri, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Consultant of Pediatric surgery

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 17, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

SA (1)