Clinical trial NCT02419534: Pediatrics Anal Fissures Treatment With Polyethylene Glycol
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fissure in Ano
Keywords: Pediatric, fissure in ano
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Previous surgeries
2. Chronic illness affecting the rectum or perianal area
3. Refuse to participate

Primary outcomes:
measure: Number of cases with healed anal fissure as detected by clinical physical exam
timeFrame: up to 8 weeks
Secondary outcomes:
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
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: College of medicine, king saud university
state: Nejd Province - Central
Study officials:
affiliation: Associate Professor & Consultant of Pediatric,Medical College, King Saud University
name: Ayman Al-Jazaeri
role: PRINCIPAL_INVESTIGATOR
References:
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