Pediatrics Anal Fissures Treatment With Polyethylene Glycol

February 27, 2016 updated by: Ayman Aljazaeri, King Saud University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Al-Jazaeri, MD

Study Locations

  • Saudi Arabia
    • Nejd Province - Central
      • Riyadh, Nejd Province - Central, Saudi Arabia
        • Recruiting
        • College Of Medicine, King Saud University
        • Contact:
          • Ayman Al-Jazaeri
          • Phone Number: (966)-5-65994455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Polyethylene glycol
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
Laxative to treat constipation
Other Names:
  • Movicol
Active Comparator: Polyethylene glycol with Diltiazem
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
Laxative and topical calcium channel blocker
Other Names:
  • Movicol + Diltiazem

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number cases with painless bowel movement detected during clinical visits or phone interviews
Time Frame: at 2,4 and 8 weeks
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
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
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
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
2, 4, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Investigators

  • Principal Investigator: Ayman Al-Jazaeri, Associate Professor & Consultant of Pediatric,Medical College, King Saud University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 27, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/4293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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