Chronic Idiopathic ConstipationPhase 4NCT02361749
Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
A Phase 4 study testing Botulinum Toxin and Anal Myectomy in people with Chronic Idiopathic Constipation and Functional Constipation, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Chronic Idiopathic Constipation, Functional Constipation
- What is being tested?
- Botulinum Toxin and Anal Myectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2014to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Idiopathic constipation
Who cannot join
- Hirschsprung's disease or Anorectal malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
Chronic idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation
Read the detailed description
Functional constipation (chronic idiopathic constipation) is most common cause of constipation in pediatric age group. Many cases try conservative treatment but fail to respond. These cases are treated by surgical longitudinal myectomy of the anal sphincter. Now, there have been many trials of trying injection of botulinum toxin to relax the sphincter as a treatment of functional/idiopathic constipation.
In this study, the investigators will compare the results of botulinum toxin injection versus surgical myectomy to treat functional/idiopathic constipation in children.
- Being tested
- Botulinum Toxin, Anal Myectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum ToxinDrug
Also called Botox
Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.
Anal MyectomyProcedure or surgery
Longitudinal anal myectomy will be performed under general anesthesia as a day case.
| Study group | Role | What they receive |
|---|---|---|
| Myectomy group | Active comparator | Subjects will undergo anal myectomy for their anal sphincter. Receives: Procedure: Anal Myectomy |
| Botox Group | Active comparator | Subjects will undergo Botulinum toxin injection into their anal sphincter. Receives: Drug: Botulinum Toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
Rome III Diagnostic criteria for chronic idiopathic constipation include two or more of the following in a child with a developmental age of at least 4 years:
- Two or fewer defecations in the toilet per week
- 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 which may obstruct the toilet
Outcome measure for Curing Chronic idiopathic constipation is denoted by absence of insufficient criteria (0-1 criterion) to diagnose Chronic idiopathic constipation after receiving corresponding arm of the study.
Measured: 2 years
Secondary outcomes (1)
Decrease in Rome III Diagnostic criteria score
Rome III Diagnostic criteria for chronic idiopathic constipation include two or more of the following in a child with a developmental age of at least 4 years:
- Two or fewer defecations in the toilet per week
- 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 which may obstruct the toilet
Outcome measure for improving Chronic idiopathic constipation is denoted by giving each case a 6-point score system based on Chronic idiopathic constipation diagnostic criteria. Improvement is denoted by decrease in diagnostic criteria score after receiving corresponding arm of the study. The decrease is assessed, analyzed and compared between the two groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Idiopathic ConstipationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elfiky, MD, Cairo University
- Investigators
- Mohamed Seoudi, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361749
- Sponsor's protocol ID
- CAIUNIPEDSURG-CR2
- Other IDs
- PACTR201408000857349
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2015
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: WOFAPS 2016
Publications
Keshtgar AS, Ward HC, Sanei A, Clayden GS. Botulinum toxin, a new treatment modality for chronic idiopathic constipation in children: long-term follow-up of a double-blind randomized trial. J Pediatr Surg. 2007 Apr;42(4):672-80. doi: 10.1016/j.jpedsurg.2006.12.045.
PubMed 17448764Irani K, Rodriguez L, Doody DP, Goldstein AM. Botulinum toxin for the treatment of chronic constipation in children with internal anal sphincter dysfunction. Pediatr Surg Int. 2008 Jul;24(7):779-83. doi: 10.1007/s00383-008-2171-3. Epub 2008 Apr 29.
PubMed 18443801Hata Y, Sasaki F, Uchino J. Sphincteromyectomy and sphincteroplasty in chronic constipation with megarectum. J Pediatr Surg. 1988 Feb;23(2):141-2. doi: 10.1016/s0022-3468(88)80143-x.
PubMed 3343649Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.
PubMed 16678553
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
- ClinicalTrials.gov ID
- NCT02361749
- Acronym / sponsor ID
- CAIUNIPEDSURG-CR2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation
Detailed description
Functional constipation (chronic idiopathic constipation) is most common cause of constipation in pediatric age group. Many cases try conservative treatment but fail to respond. These cases are treated by surgical longitudinal myectomy of the anal sphincter. Now, there have been many trials of trying injection of botulinum toxin to relax the sphincter as a treatment of functional/idiopathic constipation.
In this study, the investigators will compare the results of botulinum toxin injection versus surgical myectomy to treat functional/idiopathic constipation in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myectomy group | Active comparator | Procedure: Anal MyectomySubjects will undergo anal myectomy for their anal sphincter. |
| Botox Group | Active comparator | Drug: Botulinum ToxinSubjects will undergo Botulinum toxin injection into their anal sphincter. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with Idiopathic constipation
Key exclusion criteria (1 listed)
- Hirschsprung's disease or Anorectal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum ToxinAlso: BotoxInjection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session. | Drug | Botox Group |
| Anal MyectomyLongitudinal anal myectomy will be performed under general anesthesia as a day case. | Procedure or surgery | Myectomy group |
Primary outcome
Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
Time frame: 2 years
Rome III Diagnostic criteria for chronic idiopathic constipation include two or more of the following in a child with a developmental age of at least 4 years: 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 which may obstruct the toilet Outcome measure for Curing Chronic idiopathic constipation is denoted by absence of insufficient criteria (0-1 criterion) to diagnose Chronic idiopathic constipation after receiving corresponding arm of the study.
1 secondary outcome
Decrease in Rome III Diagnostic criteria score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Background: PubMed 17448764Keshtgar AS, Ward HC, Sanei A, Clayden GS. Botulinum toxin, a new treatment modality for chronic idiopathic constipation in children: long-term follow-up of a double-blind randomized trial. J Pediatr Surg. 2007 Apr;42(4):672-80. doi: 10.1016/j.jpedsurg.2006.12.045.
- Background: PubMed 18443801Irani K, Rodriguez L, Doody DP, Goldstein AM. Botulinum toxin for the treatment of chronic constipation in children with internal anal sphincter dysfunction. Pediatr Surg Int. 2008 Jul;24(7):779-83. doi: 10.1007/s00383-008-2171-3. Epub 2008 Apr 29.
- Background: PubMed 3343649Hata Y, Sasaki F, Uchino J. Sphincteromyectomy and sphincteroplasty in chronic constipation with megarectum. J Pediatr Surg. 1988 Feb;23(2):141-2. doi: 10.1016/s0022-3468(88)80143-x.
- Background: PubMed 16678553Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.
- Individual participant dataSharing planned: Yes. WOFAPS 2016
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Seoudi principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin and Anal Myectomy in people with Chronic Idiopathic Constipation and Functional Constipation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of insufficient Rome III Diagnostic criteria (0-1 criterion) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361749, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.