Evaluation of the Triple Management Program in the Management of Functional Chronic Constipation in Children
Condition: Constipation Chronic Idiopathic
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Abstract Background: Chronic constipation is a common disease in children, 3% all children
      visit gastroenterology clinics with different types and complains. It is very harsh, time
      consuming and psychological problems to a child and all his family members.

      Objective: To find a simple and effective training method that manages the bowel habits
      intervals both easy and effective for both child and parents.

      Patients and methods: A training program for 18 weeks in 180 children with follow up every
      three months for 3 years between March 2016 and April 2019. Two groups were assembled, Group
      (A) with 90 children managed by the 3 Role program and Group (B) formed of the other 90
      children treated with traditional guidelines. All types of functional Constipations and all
      ages are distributed equally in the two Groups. The Parents were taught to Hang a Sign Saying
      (One Bowel habit by third day at least) and then follow the Triple method program for 18
      weeks. First follow up is on the 3rd week. The triple axis program is working on mental,
      colon elasticity and fecal consistency. The Mental axis is done by bowel interval sets in
      fixed 3 times for 10 minutes in each, Colon contents by certain diet protocol and colon
      motility and elasticity by drugs.
    

Detailed description: 
      -  Introduction Functional constipation (FC) is a common problem in children, with an
           estimated worldwide incidence of 9.5% . If there is no underlying organic reason, which
           is the case in up to 95% of children, constipation is classified as FC. The etiology of
           the 5% of cases with an organic origin range from metabolic to endocrine problems to
           Hirschsprung disease, anorectal malformations, and neuromuscular diseases. To diagnose
           Constipation in a child clinically, it is currently based on the pediatric diagnostic
           Rome IV criteria, Figure 1. Constipation poses a significant burden on both children and
           their family and is associated with a reduced quality of life, diminished academic
           performances and psychological problems including aggression, anxiety, depression, and
           altered emotional reactivity. Moreover, constipation is common in children with
           behavioral disorders, such as attention deficit hyperactivity disorder and autism
           spectrum disorders . Symptoms of FC may persist into adulthood despite adequate laxative
           treatment. The pathophysiology of constipation is multifactorial and incompletely
           understood. In more than 90 % of the cases, there is no organic explanation for the
           symptoms. Genetic predisposition, low-socio economic status, inadequate daily fiber
           intake, insufficient fluid intake, and immobility have been proposed as factors leading
           to FC. The most encountered etiological factor in children is withholding behavior,
           usually occurring after experiencing a painful or frightening evacuation of stools. Rome
           III criteria are commonly used to define functional constipation. Children with
           developmental age of at least 4 years must fulfill two or more of the following
           criteria. They should have insufficient criteria for diagnosis of irritable bowel
           syndrome. The criteria must be fulfilled at least once per week for at least 2 months
           before diagnosis. There should be no evidence of an organic disease explaining the
           symptoms .

             1. Two or fewer defecations in the toilet per week.

             2. At least one episode of fecal incontinence per week.

             3. History of retentive posturing or excessive volitional stool retention.

             4. History of painful or hard bowel movements.

             5. Presence of a large fecal mass in the rectum.

             6. History of large diameter stools. Almost identical criteria have been defined for
                infants and toddlers. Those criteria should be fulfilled for at least 1 month .

        -  Treatment regimens Conventional treatment of children with Functional Constipation
           involves non-pharmacological interventions (education, toilet training, defecation
           diary, and reward system) in combination with pharmacological interventions such as oral
           laxatives, of which poly-ethylene glycol is the first-line drug of choice.

      Alternative treatment options for children with intractable constipation are limited and
      include anal sphincter botulinum toxin injections, trans anal irrigation, antegrade continent
      enemas (ACE), and, in rare cases, sacral nerve stimulation (SNS) and partial or total
      surgical resection of the colon15. and is frequently associated with fecal incontinence. In
      pediatrics, fecal incontinence has been defined as the voluntary or involuntary passage of
      feces into the underwear or in socially inappropriate places, in a child with a developmental
      age of at least 4 years. It has been suggested that in otherwise healthy children, fecal
      incontinence is secondary to 'overflow', and therefore results from the presence of
      constipation . This review aims to find a simple and effective training method that manages
      the bowel habits intervals both easy and effective for both child and parents. The exact
      prevalence of functional fecal incontinence associated with stool retention varies.

      • Methodology A training program for 18 weeks in 180 children with follow up every three
      months for 3 years between March 2016 and April 2019. Two groups were assembled, Group (A)
      formed of the other 90 children treated with the 3 role program and Group (B) with 90
      children managed by the previously mentioned traditional guidelines. All types of
      Constipations and all ages are distributed equally in the two Groups. The Parents in Group A
      were thought to Hang a Sign of (One Bowel habit by third day at least) and then follow the
      triple method program for 3 months. First follow up is on the 3rd week. The triple axis
      program is working on Psychic and mental axis, colon to retain its elasticity and fecal
      consistency.

      I. The Mental axis (Gut-Brain interaction)

        1. Habit timing training:

           It is done by bowel interval sets in fixed 3 times for 10-15 minutes of each, the
           preferred timing for training is just after breakfast, lunch and one hour before
           bedtime. The training is done to seek the regain of brain-Colon reflex and to bypass the
           psychic trauma of the child due to constipation with overflow which was wrongly
           diagnosed as incontinence. While the child was sitting in the toilet, no commands were
           directed to him/her. As there is no need to give a burden to his rehabilitation and to
           ensure that the axis is involuntarily done.

           Child is asked to leave the toilet even if there is no desire for defecation.

        2. Exercise and daily activity:

           Increased daily activity and frequent exercise is favored to increase bowel movement and
           decrease psychic distress. Regular sports by fixed timing triple a week is encouraged.

        3. Psychic therapy:

      Family support is a golden axis for management progress, the feeling of security and backing
      plays an important role in fixing the problem and increase morale. Sometimes a child may need
      a psychiatric visit if it was a long time of constipation, and the overflow left a psychic
      trauma to the child.

      II. The Pharmacological Colon Support That was done by trying to reduce the impacted colon
      load as to regain the lost or altered elasticity through the longtime of constipation and
      reabsorption of fluids through increased contact time between fecal matter and Intestine. The
      golden role that was informed to parents is that the hanged sign should be joined with drug
      protocol according to bowel evacuation intervals. So, another sign is drawn to parents with
      medication role related to bowel habits, to be easy remembered a card was designed as traffic
      light with Stop, Care and Go orders according to defecation modes Fig (2,3). An osmotic
      laxative medication (Lactulose) is thought to be a green light medication for a three-month
      period of program. If more than 24 hours with no defecation happened a yellow sign is hanged
      and a Na picosulphate drops is prescribed for the second day, if still no acceptable
      defecation retained, a red sign on the third day is waved and a local Enema with
      Mono/disodium phosphate is applied, then a green sign is regained. This regimen is maintained
      for three months and first follow-up with complete data on using the yellow or red sign is
      achieved within the first three weeks.

        -  Diet protocol As done with medication protocol, another traffic light card with
           instructions of which food can go (Green) as vegetables, Laxative fruits, and plenty of
           fluids. Other diet groups may be taken with caution (yellow) as Proteins, dairy products
           and low to medium doses of carbohydrates. While the last group (Red) should be quietly
           banned as conservatives contained diets, fats or constipating or citrus fruits. child is
           advised to take his main meals at a fixed time.

        -  Follow up. A Statistical sheet is delivered to parents to fulfill the numbers of bowel
           habits per day, how many times we had to take Picosulphate drops and/or Enemas? how many
           times has the child had soiled underwear? and how many times he succeeded in defecating
           during toilet training.

      Figure 1: Rome IV disorders of chronic constipation5.

      Child/Adolescent, 12

      A minimum of 1 month of two or more of the following occurring at least once per week, with
      insufficient criteria for a diagnosis of irritable bowel:

        -  Two or fewer defecation in the toilet per week in a child of developmental age of at
           least 4 years.

        -  At least one episode of fecal incontinence per week.

        -  History of retentive posturing or excessive volitional stool retention.

        -  History of painful or hard bowel movements.

        -  Presence of a large fecal mass in the rectum.

        -  History of large diameter stools that can obstruct the toilet after appropriate
           evaluation, the symptoms cannot be fully explained by another medical condition.

      After appropriate evaluation, the symptoms cannot be fully explained by another medical
      condition.

      Figure 2: Traffic sign card of diet regimen.

      Figure 3: Traffic sign card of drug protocol

      One Bowel habit by third day at least.

      Figure 4: The golden role sign.
    

Intervention name(s): laxatives
Intervention type(s): Combination Product
Intervention description(s): triple therapy of drugs, behaviour and mental axis
Intervention MeSH terms: Laxatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: constipation; pediatrics; ACE; non surgical