Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569446
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Barriers to Rectal Irrigation in Defaecatory Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understanding the Barriers to Rectal Irrigation in Patients With Defaecatory Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 constipation1 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 support3 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
Detailed Description:
Rectal irrigation is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation Proposed mechanisms of action include simple mechanical washout colonic movement stimulated by the washout or a combination of these1
By regularly emptying the bowel in this manner rectal irrigation helps re-establish control of bowel function and enables the patients to choose the time and place of evacuation thus re-instating more predictable bowel movement 2 and therefore allowing them to have a better quality of life
National Institute for Health and Care Excellence recommends that rectal irrigation be considered in patients with constipation8 and faecal incontinence 9 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 support10
Studies have looked at outcomes of rectal irrigation in patients with defaecatory difficulties 61112 where improvement in symptoms or quality of life in patients after using irrigation has been reported Christensen reported that 52 of the patients used rectal irrigation for a median of 8 months before discontinuing treatment11 where reasons for discontinuation were unsatisfactory effect faecal incontinence time consumption disliking for treatment side effects leakage of irrigation fluid and expulsion of rectal catheter Tamvakeras reported four 22 out of eighteen patients discontinued rectal irrigation in a median length of 48 months Three of the four patients who discontinued rectal irrigation found it ineffective while the fourth patient discontinued due to resolution of symptoms12
Barriers to using rectal irrigation other than side-effects or unsatisfactory outcome still need to be explored such as cultural or social reasons and lack of knowledge or fear about the treatment
The investigators aim to organize focused group sessions and cognitive interviews of patients to understand the barriers to irrigation so that these can be addressed for better compliance and outcome leading to a better quality of life in patients with defaecatory difficulties
9 Study design This is a qualitative study which has two phases
112 Participant Recruitment After screening research will be introduced to the eligible participants by a member of the clinical team during their bowel function clinic appointment face-to-face telephone Participant information sheet will be provided or posted depending on type of appointment Patient details will be noted on eligibility log and passed on to the research team It will be ensured that the investigators have a fair selection of patients by stratifying them based on gender age ethnicity socio-economic status and presenting complain This will be to make sure our research cohort is as close to the actual population as possible For eg the investigators will ensure that there is equal representation of all types of ethnicity and socio-economic groups Patients will be given at least 48 hours to consider participation and will be contacted over the phone by a member of the research team Should patients require more time to think then another call will be arranged as per their convenient time The call will be to discuss the research and answer any queries the patients may have following which if the patients are happy to participate they will be invited to the focused group sessions or cognitive interviews depending on what phase of the study they are being recruited for Should they decide not to participate they will be reassured that it will not have any impact on their on-going care in the department A hospital interpreter will be arranged for patients with limited English communication skills to help with consenting attending focused group sessions and cognitive interviews For group sessions if an interpreter is required all participants will be notified via a telephone call before the session and consent will be obtained and documented
For those unable to read or write a witness from the participants family or a carer can be arranged to come into the face-to-face appointment with the participant however consent will have to be provided by the participant Patients attending face-to-face group will be consented before starting the session on the day by a member of the research team while those attending online focused group sessions will be sent e-consent forms via encrypted NHS email by a member of the research team E-consent forms will be required to be returned via email
113 Schedule of appointments
Focused Group Session - Phase 1 of study Two types of focused groups will be co-ordinated according to participants convenience and availability Group 1 will include participants who are currently using rectal irrigation or have used in the past Group 2 will include participants who had declined rectal irrigation Four participants will be recruited for each of the two groups Since the pelvic floor unit receive referrals from both urban and rural communities it may not be feasible for all participants to travel for the group sessions or some participants may feel embarrassed to attend and participate in discussion with others or feel nervous about travelling due to symptoms such as faecal incontinence Therefore to facilitate the investigators will organise both in person and virtual focused group sessions if need be Face to face group sessions will be conducted in Pelvic Floor Unit at St Thomas Hospital while virtual sessions will be conducted on Microsoft Teams Participants wanting to attend virtually will be asked for their email address to send the invitation and consent to
Each focused group will be facilitated by a member of the research team This session will last up to 60 minutes Following introductions a list of hypothesized barriers HB to using rectal irrigation will be distributed and each item on the list will be discussed by facilitator first asking a pre-determined question HB will include reasons identified by previous studies for discontinuing rectal irrigation1112 along with factors the investigators think may contribute as barriers With discussions in the focused group sessions the investigators hope to discover more barriers to rectal irrigation from participants which will be added to the list for next focused group session At the end all participants will be asked if they are aware of any barriers which have not been covered in the session and these will be noted After the session a twenty-minute talk to educate patients on rectal irrigation will be offered should participants wish to attend Focused group sessions will continue until a barrier saturation no more new barriers found upon discussion in two consecutive focused group sessions is reached Male and female participants will be assigned to separate interview groups to avoid embarrassment should the participants feel that way and find it difficult to have an open discussion
Virtual sessions will be conducted via Microsoft teams which will be both audio and video recorded Participants can turn off their cameras if they do not wish to be visually recorded This will be reminded at the start of the virtual session All face-to face focused group sessions will be audio recorded via trust encrypted recording device and transcribed At the end of the session the recording from both audio encrypted recording device and recording from Microsoft teams will be listened to and transcribed by the facilitator Participants quotes will be pseudonymised such that each participant will be assigned a registration number upon recruitment by a member of the research team for eg BRI-001 Once the summary is prepared from the transcribed notes then the audio recording and Microsoft Teams recording will be destroyed as per the sponsors instructions Until the investigators destroy them the data will be stored in the Trust computer and devices in locked cabinets in accordance with Data Protection act 2018 and the NHS Confidentiality Code of Practice
Cognitive Interviews - Phase 2 of study Ten individuals who have not participated in phase 1 of the study will be invited to attend cognitive interviews This will be to validate the barriers discovered during focused group sessions These sessions be conducted as described in line with the process described in phase 1 for the focus groups with the option of face-to-face or virtual sessions However unlike with the focus groups these will be one to one sessions
Strength This is the first study to identify and understand barriers to rectal irrigation via qualitative interviews other than complications of using the irrigation device and no improvement in symptoms It is a patient centred study to help inform clinicians about barriers to rectal irrigation faced by patients This can help take measures in future for resolution of barriers to have better outcomes and patient compliance to treatment Focused group sessions followed by educational session will also help create more awareness amongst our patients regarding using rectal irrigation It will also allow patients to feel more involved in their care and their problems regarding the treatment being listened to
Data
121 Data to be collected
Personal data Identifiable patient data will be recorded only for the purpose of contacting patients for eg name date of birth and address and will be kept confidential in a password protected file Microsoft Excel by the principle investigator PI and co-investigator TG where no third party will have access to it
Socio-demographics The co-investigator TG will assign a research registration number to each participant after recruitment and consenting such as BRI-001 All socio-demographic data will be collected against this registration number to pseudonymise data for analysis Socio-demographic data will include age gender post code to calculate proxy marker for socio-economic status and commute distance ethnicity and mode of transport to the hospital if coming for face-to-face sessioninterview
Transcribed data All representative quotes recorded and transcribed will be pseudonymised with any identifiers revealed being replaced with the participants registration number such as BRI-001
13 End of the study definition The study will be considered to have come to an end when the last patient tenth of Phase-2 of the study has undergone cognitive interview
By regularly emptying the bowel in this manner rectal irrigation helps re-establish control of bowel function and enables the patients to choose the time and place of evacuation thus re-instating more predictable bowel movement 2 and therefore allowing them to have a better quality of life
National Institute for Health and Care Excellence recommends that rectal irrigation be considered in patients with constipation8 and faecal incontinence 9 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 support10
Studies have looked at outcomes of rectal irrigation in patients with defaecatory difficulties 61112 where improvement in symptoms or quality of life in patients after using irrigation has been reported Christensen reported that 52 of the patients used rectal irrigation for a median of 8 months before discontinuing treatment11 where reasons for discontinuation were unsatisfactory effect faecal incontinence time consumption disliking for treatment side effects leakage of irrigation fluid and expulsion of rectal catheter Tamvakeras reported four 22 out of eighteen patients discontinued rectal irrigation in a median length of 48 months Three of the four patients who discontinued rectal irrigation found it ineffective while the fourth patient discontinued due to resolution of symptoms12
Barriers to using rectal irrigation other than side-effects or unsatisfactory outcome still need to be explored such as cultural or social reasons and lack of knowledge or fear about the treatment
The investigators aim to organize focused group sessions and cognitive interviews of patients to understand the barriers to irrigation so that these can be addressed for better compliance and outcome leading to a better quality of life in patients with defaecatory difficulties
9 Study design This is a qualitative study which has two phases
112 Participant Recruitment After screening research will be introduced to the eligible participants by a member of the clinical team during their bowel function clinic appointment face-to-face telephone Participant information sheet will be provided or posted depending on type of appointment Patient details will be noted on eligibility log and passed on to the research team It will be ensured that the investigators have a fair selection of patients by stratifying them based on gender age ethnicity socio-economic status and presenting complain This will be to make sure our research cohort is as close to the actual population as possible For eg the investigators will ensure that there is equal representation of all types of ethnicity and socio-economic groups Patients will be given at least 48 hours to consider participation and will be contacted over the phone by a member of the research team Should patients require more time to think then another call will be arranged as per their convenient time The call will be to discuss the research and answer any queries the patients may have following which if the patients are happy to participate they will be invited to the focused group sessions or cognitive interviews depending on what phase of the study they are being recruited for Should they decide not to participate they will be reassured that it will not have any impact on their on-going care in the department A hospital interpreter will be arranged for patients with limited English communication skills to help with consenting attending focused group sessions and cognitive interviews For group sessions if an interpreter is required all participants will be notified via a telephone call before the session and consent will be obtained and documented
For those unable to read or write a witness from the participants family or a carer can be arranged to come into the face-to-face appointment with the participant however consent will have to be provided by the participant Patients attending face-to-face group will be consented before starting the session on the day by a member of the research team while those attending online focused group sessions will be sent e-consent forms via encrypted NHS email by a member of the research team E-consent forms will be required to be returned via email
113 Schedule of appointments
Focused Group Session - Phase 1 of study Two types of focused groups will be co-ordinated according to participants convenience and availability Group 1 will include participants who are currently using rectal irrigation or have used in the past Group 2 will include participants who had declined rectal irrigation Four participants will be recruited for each of the two groups Since the pelvic floor unit receive referrals from both urban and rural communities it may not be feasible for all participants to travel for the group sessions or some participants may feel embarrassed to attend and participate in discussion with others or feel nervous about travelling due to symptoms such as faecal incontinence Therefore to facilitate the investigators will organise both in person and virtual focused group sessions if need be Face to face group sessions will be conducted in Pelvic Floor Unit at St Thomas Hospital while virtual sessions will be conducted on Microsoft Teams Participants wanting to attend virtually will be asked for their email address to send the invitation and consent to
Each focused group will be facilitated by a member of the research team This session will last up to 60 minutes Following introductions a list of hypothesized barriers HB to using rectal irrigation will be distributed and each item on the list will be discussed by facilitator first asking a pre-determined question HB will include reasons identified by previous studies for discontinuing rectal irrigation1112 along with factors the investigators think may contribute as barriers With discussions in the focused group sessions the investigators hope to discover more barriers to rectal irrigation from participants which will be added to the list for next focused group session At the end all participants will be asked if they are aware of any barriers which have not been covered in the session and these will be noted After the session a twenty-minute talk to educate patients on rectal irrigation will be offered should participants wish to attend Focused group sessions will continue until a barrier saturation no more new barriers found upon discussion in two consecutive focused group sessions is reached Male and female participants will be assigned to separate interview groups to avoid embarrassment should the participants feel that way and find it difficult to have an open discussion
Virtual sessions will be conducted via Microsoft teams which will be both audio and video recorded Participants can turn off their cameras if they do not wish to be visually recorded This will be reminded at the start of the virtual session All face-to face focused group sessions will be audio recorded via trust encrypted recording device and transcribed At the end of the session the recording from both audio encrypted recording device and recording from Microsoft teams will be listened to and transcribed by the facilitator Participants quotes will be pseudonymised such that each participant will be assigned a registration number upon recruitment by a member of the research team for eg BRI-001 Once the summary is prepared from the transcribed notes then the audio recording and Microsoft Teams recording will be destroyed as per the sponsors instructions Until the investigators destroy them the data will be stored in the Trust computer and devices in locked cabinets in accordance with Data Protection act 2018 and the NHS Confidentiality Code of Practice
Cognitive Interviews - Phase 2 of study Ten individuals who have not participated in phase 1 of the study will be invited to attend cognitive interviews This will be to validate the barriers discovered during focused group sessions These sessions be conducted as described in line with the process described in phase 1 for the focus groups with the option of face-to-face or virtual sessions However unlike with the focus groups these will be one to one sessions
Strength This is the first study to identify and understand barriers to rectal irrigation via qualitative interviews other than complications of using the irrigation device and no improvement in symptoms It is a patient centred study to help inform clinicians about barriers to rectal irrigation faced by patients This can help take measures in future for resolution of barriers to have better outcomes and patient compliance to treatment Focused group sessions followed by educational session will also help create more awareness amongst our patients regarding using rectal irrigation It will also allow patients to feel more involved in their care and their problems regarding the treatment being listened to
Data
121 Data to be collected
Personal data Identifiable patient data will be recorded only for the purpose of contacting patients for eg name date of birth and address and will be kept confidential in a password protected file Microsoft Excel by the principle investigator PI and co-investigator TG where no third party will have access to it
Socio-demographics The co-investigator TG will assign a research registration number to each participant after recruitment and consenting such as BRI-001 All socio-demographic data will be collected against this registration number to pseudonymise data for analysis Socio-demographic data will include age gender post code to calculate proxy marker for socio-economic status and commute distance ethnicity and mode of transport to the hospital if coming for face-to-face sessioninterview
Transcribed data All representative quotes recorded and transcribed will be pseudonymised with any identifiers revealed being replaced with the participants registration number such as BRI-001
13 End of the study definition The study will be considered to have come to an end when the last patient tenth of Phase-2 of the study has undergone cognitive interview
Study Oversight
Has Oversight DMC:
None
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?:
None