Psyllium Fiber Versus Placebo in Early Treatment After STARR for Obstructed Defecation: a Double-blind RCT

Constipation Clinical Trial

Official title:

Efficacia Della Fibra di Psyllium Versus Placebo Nella Gestione Dell'Alvo in Pazienti Sottoposti ad Intervento Chirurgico Per Ostruita Defecazione

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136693
• Other study ID #: psyllium_STARR
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2014
• Last updated: May 10, 2014
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2014
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Constipation
• Incontinence

Intervention

Drug:
• Psyllium fiber
3.5 g /day of pure Psyllium fiber for 180 days after STARR
• Placebo
3.5 g /day of inert compound for 180 days after STARR

Locations

Country	Name	City	State
Italy	Istituti Clinici Zucchi	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
Francesco Gabrielli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	residual constipation	ODS score and CCS score	180 days after STARR
Secondary	Post-operative pain	VAS	180 days after STARR
Secondary	revertence to laxative use	frequency percentage of patients that reverted to laxative use after surgery	180 days after STARR
Secondary	change in fecal incontinence from baseline	Wexner Incontinence score	180 days after STARR
Secondary	post-operative defecation urgency	defecation urgency incidence	180 days after STARR