Barriers to Rectal Irrigation in Defaecatory Dysfunction

NCT06569446 | Not Yet Recruiting DMC

• 1 other identifier: 336619
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

chronic constipation; rectal irrigation; trans-anal irrigation; evacuation disorders; faecal incontinence; barriers; patient interviews; structured interviews

Outcome Measures

Primary Outcomes (1)

• Barriers to rectal irrigation

  To understand the barriers to rectal irrigation in patients with defaecatory dysfunction by conducting focused group sessions.

  60 minutes

Secondary Outcomes (1)

• Validate barriers to rectal irrigation

  60 minutes

Study Arms (2)

Focused Group Sessions

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).

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

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.

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

Interventions

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

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.

Cognitive Interviews; Focused Group Sessions

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The following patients will be excluded: * Lack capacity * Unable to participate in discussion

You may qualify if:

• Patients who
• are/have
• currently using rectal irrigation
• have previously used rectal irrigation
• declined rectal irrigation
• equal to or over 18 years
• have defaecatory difficulties
• Failed nurse-led biofeedback treatment
• have ability and willingness to give informed consent

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Related Publications (9)

• Christensen P, Krogh K. Transanal irrigation for disordered defecation: a systematic review. Scand J Gastroenterol. 2010 May;45(5):517-27. doi: 10.3109/00365520903583855.

  PMID: 20199336 BACKGROUND

• Krogh K, Ostergaard K, Sabroe S, Laurberg S. Clinical aspects of bowel symptoms in Parkinson's disease. Acta Neurol Scand. 2008 Jan;117(1):60-4. doi: 10.1111/j.1600-0404.2007.00900.x.

  PMID: 18095955 BACKGROUND

• Shandling B, Gilmour RF. The enema continence catheter in spina bifida: successful bowel management. J Pediatr Surg. 1987 Mar;22(3):271-3. doi: 10.1016/s0022-3468(87)80345-7.

  PMID: 3550032 BACKGROUND

• Briel JW, Schouten WR, Vlot EA, Smits S, van Kessel I. Clinical value of colonic irrigation in patients with continence disturbances. Dis Colon Rectum. 1997 Jul;40(7):802-5. doi: 10.1007/BF02055436.

  PMID: 9221856 BACKGROUND

• Gardiner A, Marshall J, Duthie G. Rectal irrigation for relief of functional bowel disorders. Nurs Stand. 2004 Nov 10-16;19(9):39-42. doi: 10.7748/ns2004.11.19.9.39.c3755.

  PMID: 15574053 BACKGROUND

• Crawshaw AP, Pigott L, Potter MA, Bartolo DC. A retrospective evaluation of rectal irrigation in the treatment of disorders of faecal continence. Colorectal Dis. 2004 May;6(3):185-90. doi: 10.1111/j.1463-1318.2004.00584.x.

  PMID: 15109384 BACKGROUND

• Pakzad M, Telford K, Ward K, Keighley M. Seizing the opportunity to improve patient care: pelvic floor services in 2021 and beyond. Br J Hosp Med (Lond). 2021 Sep 2;82(9):1-3. doi: 10.12968/hmed.2021.0387. Epub 2021 Sep 16.

  PMID: 34601937 BACKGROUND

• Christensen P, Krogh K, Buntzen S, Payandeh F, Laurberg S. Long-term outcome and safety of transanal irrigation for constipation and fecal incontinence. Dis Colon Rectum. 2009 Feb;52(2):286-92. doi: 10.1007/DCR.0b013e3181979341.

  PMID: 19279425 BACKGROUND

• Tamvakeras P, Horrobin C, Chang J, Chapman M. Long-Term Outcomes of Transanal Irrigation for Bowel Dysfunction. Cureus. 2023 Jul 26;15(7):e42507. doi: 10.7759/cureus.42507. eCollection 2023 Jul.

  PMID: 37502470 BACKGROUND

Related Links

• NICE guidelines for management of faecal incontinence in adults
• Biofeedabck

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Alison Hainsowrth, FRCS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanzeela Gala, FCPS-Surgery

CONTACT

+447496288119; tanzeela.gala@gstt.nhs.uk

Alison Hainsworth, FRCS

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share