ConstipationPhase 4NCT02136693
Psyllium Fiber Versus Placebo in Early Treatment After STARR for Obstructed Defecation: a Double-blind RCT
A Phase 4 study testing Psyllium fiber in people with Constipation and Incontinence, run by Francesco Gabrielli at 1 site in Italy.
Trial summary
This study aims to assess whether fiber intake, formerly recommended only before or instead of surgery, may play a role in improving postoperative progress and functional outcome after STARR for obstructed defecation, in terms of residual constipation, incontinence and defecation urgency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Incontinence
- What is being tested?
- Psyllium fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- May 2010to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age over 18
- Diagnosis of Obstructed Defecation Syndrome according to ODS and CCS Score
- STARR performed when ODS score >10
- STARR performed 48-72 hours before
Who cannot join
- Puborectalis or sphincter dyssynergia, evaluated by defecography and / or anorectal manometry
- Concomitant diseases (fissure, abscess, fistula, IBD, diverticular disease)
- Prolapse of other pelvic floor organs
- Proctological surgery before STARR
- Pregnancy or breast-feeding
- Ongoing treatment with oral anticoagulants or steroid therapy
- Conditions that do not allow patients to understand the nature and the purpose of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacia Della Fibra di Psyllium Versus Placebo Nella Gestione Dell'Alvo in Pazienti Sottoposti ad Intervento Chirurgico Per Ostruita Defecazione
This study aims to assess whether fiber intake, formerly recommended only before or instead of surgery, may play a role in improving postoperative progress and functional outcome after STARR for obstructed defecation, in terms of residual constipation, incontinence and defecation urgency.
Read the detailed description
After obtaining written informed consent and collecting baseline scores (T0), each patient was randomly assigned to one of the two groups and began taking sachets containing Psyllium fiber 3.5 g / day for Active group (A) and inert compound for Placebo group (P).
Sachet content was assigned by software randomization, written on a list and sealed in an envelope, which was opened only after the study was completed.
Post-operative instructions for both groups included only analgesic therapy (Ketorolac 10 to 30 mg b.m. if needed). Patients were also asked to stop any former laxative and to continue on a normal diet.
Each patient was re-evaluated at 7 ± 3 (T1), 60 ± 5 (T2) and 180 ± 15 (T3) days after surgery (Table 2).
A fluoroscopic colpocystodefecography (with patient sitting upright) was obtained before surgery and between 60-180 days postoperatively in order to assess comparability of the two groups and exclude negative organic outcomes that could affect functional results.
Medical events were investigated while checking each patient, with special regard to defecation urgency. From the data collected on concomitant medications, we extrapolated those related to laxative intake.
The treatment was considered accomplished in patients who had taken at least 70% of the product during each interval of follow-up.
Statistical analysis was performed using the SPSS - PASW Statistics 18.0.0 (IBM ©, 2009).
For the general and defecographic characteristics, the data are expressed in the form of mean ± standard deviation for continuous variables and absolute frequency (frequency percentages) for categorical variables. The differences between the two groups were calculated by two-tailed t-test or chi-square when appropriate.
Scores for the assessment of clinical data are expressed as mean ± standard deviation and analysis of the differences in the two groups was performed using the two-tailed t-test. The analysis of not normally distributed variables was conducted using a non-parametric test (Wilcoxon-Mann-Whitney).
Analyses related to defecation urgency and use of laxatives were carried out using chi-square test and the data are expressed as absolute frequency (frequency percentage).
For all tests, a value of p <0.05 was considered significant.
- Conditions
- Constipation, Incontinence
- Being tested
- Psyllium fiber, Placebo
- Keywords
- obstructed defecation, STARR, constipation, incontinence, psyllium
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium fiberDrug
3.5 g /day of pure Psyllium fiber for 180 days after STARR
PlaceboDrug
Also called inert compound
3.5 g /day of inert compound for 180 days after STARR
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3.5 g /day of inert compound for 180 days after STARR Receives: Drug: Placebo |
| Psyllium fiber | Experimental | 3.5 g /day of pure Psyllium fiber for 180 days after STARR Receives: Drug: Psyllium fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual constipation
ODS score and CCS score
Measured: 180 days after STARR
Secondary outcomes (4)
Post-operative pain
VAS
Measured: 180 days after STARR
revertence to laxative use
frequency percentage of patients that reverted to laxative use after surgery
Measured: 180 days after STARR
change in fecal incontinence from baseline
Wexner Incontinence score
Measured: 180 days after STARR
post-operative defecation urgency
defecation urgency incidence
Measured: 180 days after STARR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco Gabrielli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco Gabrielli, University of Milano Bicocca
- Investigators
- Francesco Gabrielli, Prof., Study chair, Università degli studi Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136693
- Sponsor's protocol ID
- psyllium_STARR
- Status last verified
- May 2014
- First submitted
- 5 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacia Della Fibra di Psyllium Versus Placebo Nella Gestione Dell'Alvo in Pazienti Sottoposti ad Intervento Chirurgico Per Ostruita Defecazione
- ClinicalTrials.gov ID
- NCT02136693
- Acronym / sponsor ID
- psyllium_STARR
- Conditions
- Constipation, Incontinence
- Keywords
- obstructed defecation, STARR, constipation, incontinence, psyllium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Francesco GabrielliUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 May 2014 (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.
This study aims to assess whether fiber intake, formerly recommended only before or instead of surgery, may play a role in improving postoperative progress and functional outcome after STARR for obstructed defecation, in terms of residual constipation, incontinence and defecation urgency.
Detailed description
After obtaining written informed consent and collecting baseline scores (T0), each patient was randomly assigned to one of the two groups and began taking sachets containing Psyllium fiber 3.5 g / day for Active group (A) and inert compound for Placebo group (P).
Sachet content was assigned by software randomization, written on a list and sealed in an envelope, which was opened only after the study was completed.
Post-operative instructions for both groups included only analgesic therapy (Ketorolac 10 to 30 mg b.m. if needed). Patients were also asked to stop any former laxative and to continue on a normal diet.
Each patient was re-evaluated at 7 ± 3 (T1), 60 ± 5 (T2) and 180 ± 15 (T3) days after surgery (Table 2).
A fluoroscopic colpocystodefecography (with patient sitting upright) was obtained before surgery and between 60-180 days postoperatively in order to assess comparability of the two groups and exclude negative organic outcomes that could affect functional results.
Medical events were investigated while checking each patient, with special regard to defecation urgency. From the data collected on concomitant medications, we extrapolated those related to laxative intake.
The treatment was considered accomplished in patients who had taken at least 70% of the product during each interval of follow-up.
Statistical analysis was performed using the SPSS - PASW Statistics 18.0.0 (IBM ©, 2009).
For the general and defecographic characteristics, the data are expressed in the form of mean ± standard deviation for continuous variables and absolute frequency (frequency percentages) for categorical variables. The differences between the two groups were calculated by two-tailed t-test or chi-square when appropriate.
Scores for the assessment of clinical data are expressed as mean ± standard deviation and analysis of the differences in the two groups was performed using the two-tailed t-test. The analysis of not normally distributed variables was conducted using a non-parametric test (Wilcoxon-Mann-Whitney).
Analyses related to defecation urgency and use of laxatives were carried out using chi-square test and the data are expressed as absolute frequency (frequency percentage).
For all tests, a value of p <0.05 was considered significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo3.5 g /day of inert compound for 180 days after STARR |
| Psyllium fiber | Experimental | Drug: Psyllium fiber3.5 g /day of pure Psyllium fiber for 180 days after STARR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Age over 18
- Diagnosis of Obstructed Defecation Syndrome according to ODS and CCS Score
- STARR performed when ODS score >10
- STARR performed 48-72 hours before
Key exclusion criteria (7 listed)
- Puborectalis or sphincter dyssynergia, evaluated by defecography and / or anorectal manometry
- Concomitant diseases (fissure, abscess, fistula, IBD, diverticular disease)
- Prolapse of other pelvic floor organs
- Proctological surgery before STARR
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Psyllium fiber3.5 g /day of pure Psyllium fiber for 180 days after STARR | Drug | Psyllium fiber |
| PlaceboAlso: inert compound3.5 g /day of inert compound for 180 days after STARR | Drug | Placebo |
Primary outcome
residual constipation
Time frame: 180 days after STARR
ODS score and CCS score
4 secondary outcomes
Post-operative pain
Time frame: 180 days after STARR
revertence to laxative use
Time frame: 180 days after STARR
change in fecal incontinence from baseline
Time frame: 180 days after STARR
post-operative defecation urgency
Time frame: 180 days after STARR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Francesco Gabrielli, Prof. study chair
Università degli studi Milano Bicocca
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 Psyllium fiber in people with Constipation and Incontinence, run by Francesco Gabrielli at 1 site in Italy.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 13 May 2014. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
residual constipation (time frame: 180 days after STARR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2014.