Ignite Creation Date:
2025-12-25 @ 1:00 AM
Ignite Modification Date:
2026-04-11 @ 9:59 PM
Study NCT ID:
NCT02136693
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2014-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psyllium Fiber Versus Placebo in Early Treatment After STARR for Obstructed Defecation: a Double-blind RCT
Sponsor:
Francesco Gabrielli
Organization:
Study Overview
Official Title:
Efficacia Della Fibra di Psyllium Versus Placebo Nella Gestione Dell'Alvo in Pazienti Sottoposti ad Intervento Chirurgico Per Ostruita Defecazione
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: