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Barriers to Rectal Irrigation in Defaecatory Dysfunction

NCT06569446 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2024-08-26

No results posted yet for this study

Summary

Rectal irrigation is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation. NICE recommends that rectal irrigation be considered in patients with constipation(1) and faecal incontinence (2) refractory to conservative measures such as lifestyle advice and pharmacological therapy, and bio-feedback therapy which is a treatment to help patients learn to strengthen or relax their pelvic floor muscles to improve bowel or bladder function by retraining the pelvic floor muscles and provides psychosocial support(3). Studies have shown that up to half patients discontinue rectal irrigation within a year of commencing therapy (4) (5). The investigators want to understand barriers to rectal irrigation by conducting focused group sessions and cognitive interviews of patients who have used or declined rectal irrigation.

Conditions

  • Defecation Disorder
  • Constipation - Functional
  • Constipation by Outlet Obstruction
  • Faecal Incontinence
  • Faecal Smearing
  • Obstructive Defecation Syndrome

Interventions

OTHER

There is no intervention. This a qualitative study to explore barriers to rectal irrigation

This will involve semi-structured, open-ended questions about hypothesized barriers to rectal irrigation where the interviewer will ask a pre-determined number of questions and the participants will answer which will further initiate discussion allowing new themes to emerge. After the entire list of barriers is discussed, participants will be asked if they have any new barriers to add which have not been discussed. All new barriers identified will be added to the hypothesized barriers list for the next focused group sessions. Focused group sessions will continue until no new barriers are found in two consecutive sessions (thematic saturation). 9.2 Phase - 2 includes Cognitive Interviews This will involve semi-structured, open-ended questions about barriers to rectal irrigation identified during focused group sessions where the interviewer will ask pre-determined number of questions for individual participants to answer.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alison Hainsowrth, FRCS · Guy's and St Thomas' NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2024-12-31
Completion
2025-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569446 on ClinicalTrials.gov