NCT00286520

Brief Summary

The study aims to compare a newly developed system for transanal colonic irrigation (Peristeen Anal Irrigation) with a bowel management regime that does not include irrigation in a prospective, randomized trial in spinal cord lesion patients (SCL- patients) with faecal incontinence and/or constipation. Population; 80 SCL- patients with faecal incontinence and/or constipation from five countries. Focus on: Bowel symptom score Neurogenic Bowel Dysfunction score Symptom related quality of life questionnaire Time expenditure for performance of bowel care ans side effects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
Last Updated

February 3, 2006

Status Verified

February 1, 2006

First QC Date

January 30, 2006

Last Update Submit

February 2, 2006

Conditions

ConstipationFecal IncontinenceSpinal Cord Injury

Keywords

ConstipationFecal incontinenceSpinal cord injurytransanal irrigationquality of life

Outcome Measures

Primary Outcomes (2)

  • Cleveland Clinic Constipaton Scoring System

  • St. Mark's Fecal Incontinence Grading System

Secondary Outcomes (2)

  • Neurogenic Bowel Dysfunction Score

  • American Society of Colorectal Surgeon Fecal Incontinence Score

Interventions

Transanal irrigation with Peristeen Anal IrrigationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or over
  • Spinal cord lesion at any level at least 3 months from injury
  • At least one or more of the following symptoms:
  • Spending ½ hour or more attempting to defecate each day or every second day
  • Symptoms of autonomic dysreflexia before or during defecation
  • Abdominal discomfort before or during defecation
  • Episodes of faecal incontinence once or more per month
  • The patient is able to understand the treatment and is willing to comply with the prescribed regimen
  • The patient is able to perform transanal colonic irrigation seated on a toilet commode with or without assistance
  • Signed informed consent has been obtained

You may not qualify if:

  • Co-existing major unsolved physical problems due to the injury
  • Perform transanal retrograde irrigation on a regular basis
  • Evidence of bowel obstruction
  • Evidence of inflammatory bowel disease
  • History of cerebral palsy or cerebral apoplexy
  • Multiple sclerosis
  • Diabetic polyneuropathy
  • Previous abdominal or perianal surgery (not including minor surgery as appendectomy or haemorrhoidectomy)
  • Pregnant or lactating
  • Evidence of spinal chock
  • Mentally unstable
  • Treatment with more than 5 mg prednisolon per day.
  • PNS implant (sacral nerve stimulation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Research Unit, Department of Surgery P, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (3)

  • Christensen P, Olsen N, Krogh K, Bacher T, Laurberg S. Scintigraphic assessment of retrograde colonic washout in fecal incontinence and constipation. Dis Colon Rectum. 2003 Jan;46(1):68-76. doi: 10.1007/s10350-004-6498-0.

    PMID: 12544524BACKGROUND

  • Christensen P, Kvitzau B, Krogh K, Buntzen S, Laurberg S. Neurogenic colorectal dysfunction - use of new antegrade and retrograde colonic wash-out methods. Spinal Cord. 2000 Apr;38(4):255-61. doi: 10.1038/sj.sc.3100991.

    PMID: 10822397BACKGROUND

  • Krogh K, Olsen N, Christensen P, Madsen JL, Laurberg S. Colorectal transport during defecation in patients with lesions of the sacral spinal cord. Neurogastroenterol Motil. 2003 Feb;15(1):25-31. doi: 10.1046/j.1365-2982.2003.00381.x.

    PMID: 12588466BACKGROUND

MeSH Terms

Conditions

ConstipationFecal IncontinenceSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Soeren Laurberg, professor, D.M.Sci

    Surgical Research Unit, Department of Surgery P, Aarhus University Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2006

First Posted

February 3, 2006

Study Start

December 1, 2003

Study Completion

August 1, 2005

Last Updated

February 3, 2006

Record last verified: 2006-02

Locations

DK(1)