Clinical Trial: Pediatrics Anal Fissures Treatment With Polyethylene Glycol

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Controlled Trial Comparing the Efficacy of Polyethylene Glycol Alone and Polyethylene Glycol Combined With Topical Diltiazem in Treating Anal fissure in Children

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

Detailed Summary:

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.

Current 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.

There 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 u
Sponsor: King Saud University

Current Primary Outcome: Number of cases with healed anal fissure as detected by clinical physical exam [ Time Frame: up to 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number cases with painless bowel movement detected during clinical visits or phone interviews [ Time Frame: at 2,4 and 8 weeks ]
  • Number of individuals with minimal or no straining during bowel movement detected during clinical visits or phone interviews [ Time Frame: at 2, 4, and 8 weeks ]
  • Number of cases that are passing soft bowel movements detected during clinical visits or phone interviews [ Time Frame: at 2, 4, and 8 weeks ]
  • Number of cases who are passing > 3 watery bowel movement (Diarrhea) detected during clinical visits or phone interviews [ Time Frame: 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 [ Time Frame: 2, 4, and 8 weeks ]


Original Secondary Outcome: Same as current

Information By: King Saud University

Dates:
Date Received: April 2, 2015
Date Started: November 2014
Date Completion: November 2016
Last Updated: February 27, 2016
Last Verified: February 2016