Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100055
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-10-10
Brief Title:
The ReVo Study Low-volume vs High-volume Rectal Irrigation
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
The ReVo Study REctal Irrigation VOlume Study - Low Versus High Volume Irrigation - Optimising Rectal Irrigation Volume in Evacuatory Dysfunction A Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReVo
Brief Summary:
Rectal irrigation which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation is recommended to be considered in patients with chronic constipation which is refractory to conservative measures such as lifestyle modification laxatives nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support
Two systems of rectal irrigation are available based on volume delivered low and high volume It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology
Therefore a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum
This trialresearch aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum
The main questions it aims to answer are
if one type of rectal irrigation is superior to the other
whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound
assess the acceptability and response rates to rectal irrigation
Participants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups This will purely be by chance where the possibility of being in either of the groups will be 50 They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms Lastly they will be provided training on using rectal irrigation the type they have been assigned to They will then be asked to commence irrigation at home from the next day
Participants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again This data will then be used to assess any improvement in symptoms after using rectal irrigation After three months of using rectal irrigation participation in the trial will come to and end
Two systems of rectal irrigation are available based on volume delivered low and high volume It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology
Therefore a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum
This trialresearch aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum
The main questions it aims to answer are
if one type of rectal irrigation is superior to the other
whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound
assess the acceptability and response rates to rectal irrigation
Participants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups This will purely be by chance where the possibility of being in either of the groups will be 50 They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms Lastly they will be provided training on using rectal irrigation the type they have been assigned to They will then be asked to commence irrigation at home from the next day
Participants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again This data will then be used to assess any improvement in symptoms after using rectal irrigation After three months of using rectal irrigation participation in the trial will come to and end
Detailed Description:
Rectal irrigationRI is introducing warm tap water through the anal canal into the rectum to initiate defaecation It is recommended that rectal irrigation be considered in patients with evacuation disorders refractory to conservative measures and bio-feedback before performing surgery
RI is provided either as low-volumeLV or high-volumeHV It is unknown if one type of RI is superior to the other and whether one type of RI has better outcomes in patients with a particular pathology
This randomised controlled trial aims to compare outcomes between two types of RI LV and HV and assess efficacy and acceptability of RI as a therapy in patients with Chronic constipation CC secondary to evacuation disorders ED
Primary Objective To compare the impact of LV RI versus HV RI upon disease-specific quality of life at three months in patients with CC secondary to ED
Secondary Objectives
Improvement in participants symptoms from RI by measuring symptoms severity score at three months
To identify if subgroup of participants with anatomical or pathophysiological variant of ED identified on integrated total pelvic floor ultrasound TPFUS will have different outcome from using RI
Compliance to allocated type of RI and reasons for discontinuation
Visit 0 V0 Potentially eligible participants will be identified by the Co-investigatorTG from Telephone triage assessment clinic bio-feedback clinicBFB and Multi-Disciplinary Meeting in PFU at St Thomas Hospital TG will introduce the research to eligible participants by contacting via telephone or during BFB
Eligible participants will be provided with an information pack with invitation letter participant information sheet PIS and two consent forms with a return label to post one of the consent forms back for record PIS will have all details and explanation of the aims methods anticipated benefits and possible risks of RI It will also have contact details of the Principle Investigator PI and the TG should eligible participants have any questions regarding the research trial before participating or to escalate concerns during participation Participants will have at least 48 hours to consider participation
Telephone Appointment TA This will scheduled at least 48 hours after the eligible participant has received the information pack TG will contact the eligible participant to discuss the trial in detail and answer any queries After discussion if eligible participant is happy to participate both consent forms will be signed Participants will then be asked to return one consent form to the department for record return label provided There is no obligation for eligible participants to give reasons for non-participation
Participants during the trial can withdraw anytime without giving reasons and return to routine care However data collected up to that point will be used to analyse current research as per PIS and consent form
After consent a participant journal PJ will be posted with instructions to fill it in PJ will record all participants medications and visits to healthcare professionals for constipation in the past three months It will also record bowel frequency two weeks before participants first face-to-face appointment
Visit 1 Face-to-face V1F Baseline assessment randomisation TPFUS and training in RI Participants will have medical history taken and undergo a physical examination of their back passage and vagina female participants Participants will be asked to hand over PJ filled at home and fill in four questionnaires which will help investigators assess impact of constipation on participants daily routine These are PAC-QOL PAC-SYM ICIQ-B and ODS-S as described in outcome measures
Participants will be randomly assigned 11 into two groups LV RI and HV RI Investigators will use online software Clinical trial randomisation tool by National Cancer Institute for randomisation Both LV and HV irrigation will be given a code by TG PI will perform randomisation and will perform allocation concealment using sealed envelopes
Participants will undergo TPFUS which is routinely performed on all our patients It uses inaudible sound waves to provide real-time static and dynamic multi-compartmental pelvic floor assessment of anatomical and functional aspects
The RI systems used in our unit are commercially available on prescription in National Health Service NHS practice Participants will receive training on using RI system from our Nurse Specialist and will be provided equipment to commence RI at home from the next day Participants will be shown how to record the frequency and volume of RI in the PJ and record any side effects such as pain bleeding etc
Participants will be contacted via telephone one week later to check for any issues If necessary investigators will arrange another training
Visit 2- face to face V2F This appointment will be three months after starting RI where participants will fill in outcome questionnaires as in previous visit and PJ will be collected This will end participation in the research trial and participants will return to routine care in our department
During 3-month follow-up participants may be withdrawn from the trial if become lost to follow-up after at least three failed attempts by TG to make contact via at least two different methods eg telephone email and letter choose to withdraw and do not wish to participate in follow-up data collection or lose capacity
The interventions LV and HV RI proposed are those already being offered to patients with CC secondary to ED in the Pelvic Floor UnitPFU St Thomas Hospital and many specialist centres globally All interventions pose acceptable risks TPFUS has been performed routinely in most specialist centres and is considered safe RI has proven to be a low-risk intervention and has been widely used for a variety of ED Serious adverse events SAE are rare with one study reporting two non-fatal bowel perforations out of approximately 110000 irrigation therapy Other possible side effects include rectal pain bleeding painful haemorrhoids and anal fissure A recent study reported an overall adverse event AE rate of 22 with all minor and reversible events considered
This trial is categorised as Type A ie no higher than the risk of standard medical care
Any AE or SAE reported by participant will be reported to the sponsor and Ethical committee by the PI The PI may take urgent safety measures to ensure the safety and protection of the participants The PI will send the Annual Progress Report to the sponsor and Ethical committee
If the PI determines that is it within the best interests of the participants to terminate the study written notification will be given to the sponsor following which participants will be returned to the routine NHS care
The research team in the PFU will be meeting every two weeks A trial risk assessment will be conducted in collaboration with the PI and an appropriate trial monitoring and auditing plan will be produced This will be authorised by the sponsor
PAC-QOL comprises of 28 questions scored 0-4 Average score of the non-missing questions is calculated by total score divided by number of questions responded is taken as participant score out of 4 Considering improvement in score of 10 as clinically relevant we calculated sample size keeping level of significance as 5 power as 90 and standard deviation of 08 in low-volume RI and 07 in high-volume RI groups as reported by Emmett CC et al Adjusting for loss to follow up of 10 we will need 83 participants in each group However should there be a greater than 10 dropout rate which we do not feel will be the case we will then recruit more participants to be able to analyse with a significance of 5 and power of 90
Primary outcome Investigators plan to conduct intention to treat analysis to compare the two types of RI at the end of 3 months Difference in improvement in PAC-QOL score will be tested using paired sample t-test Results will be reported as means along with standard deviations of difference in pre and post rectal irrigation for both groups and the mean difference of two interventions along with 95 confidence interval with p-value less than 005 will be taken as statistically significant
Secondary outcomes Investigators plan to conduct stratified analysis based upon findings on TPFUS anatomical vs functional causes of CC secondary to evacuation disorders Compliance to RI will be shown via proportion of participants using it at the end of 3 months Adverse effects from RI will be presented as frequencies Appropriate regression models will be developed to determine the influence of pre-treatment characteristics on the success of RI in all sub-groups Analysis will be performed using Statistical Package for the Social Sciences which is an online software platform where P 005 will be taken to indicate statistical significance
Investigators plan to conduct interim analysis at half the required sample size At this point the efficacy outcome will be evaluated and if the difference between two types of RI is statistically significant enough to reach p-value of 001 then that would be considered as sufficient evidence to establish the superiority of one irrigation system over another and continuing the trial further would not be justified
In the event of a required protocol amendment details will be submitted to the sponsor for authorisation
Data Protection Upon recruitment identifiable participant data IPD will be collected on paper CRF to contact participants CRF will be stored in locked cabinets while electronic data in a password protected filePPF on Microsoft access MA Only PI and TG will have access to IPD
TG will generate and assign a unique trial registration code UTRC to each participant Each participants data will be collected and stored against the UTRC pseudonymization CRF will be kept in locked cabinets while electronic data will be recorded in PPF on MA The participants general practitioner will be informed of their participation after obtaining consent
After data collection has ended TG will create a copy of collected data without the UTRC in a PPF on Microsoft Access thus completely anonymising data which will be emailed to the Statistician via encrypted email for analysis
This study is sponsored by Guys and St Thomas NHS Foundation Trust GSTFT and indemnity is provided through NHS indemnity for clinical negligence GSTFT is a member of the clinical Negligence Scheme for Trusts
The project will be under PI and sponsor The project will be overseen by PI and co-Investigators The role of the PI will be to provide overall supervision of the study on behalf of the sponsor to ensure that research trial is conducted in accordance with the principles of Good Clinical Practice GCP relevant regulations
A study launch meeting will be conducted This will include training in the trial protocol data collection randomisation and taking informed consent
The participants will not be identifiable with regards to any future publications After trial completion the pseudonymized records will be kept for a further five years and archived with Iron Mountain All IPD will also be archived for a period of five years in locked cabinets in the Pelvic Floor Unit at St Thomas Hospital therefore no third party will have access to it At the end of the five-year retention period permission will be obtained in writing from the sponsor prior to destruction of this material
Once results are available they will first be presented in a departmental meeting followed by submission of a summary to health research authority A brief summary of the outcomes will be posted to the participants Finally results will be submitted to scientific journals or presented at a conference not involving any IPD
RI is provided either as low-volumeLV or high-volumeHV It is unknown if one type of RI is superior to the other and whether one type of RI has better outcomes in patients with a particular pathology
This randomised controlled trial aims to compare outcomes between two types of RI LV and HV and assess efficacy and acceptability of RI as a therapy in patients with Chronic constipation CC secondary to evacuation disorders ED
Primary Objective To compare the impact of LV RI versus HV RI upon disease-specific quality of life at three months in patients with CC secondary to ED
Secondary Objectives
Improvement in participants symptoms from RI by measuring symptoms severity score at three months
To identify if subgroup of participants with anatomical or pathophysiological variant of ED identified on integrated total pelvic floor ultrasound TPFUS will have different outcome from using RI
Compliance to allocated type of RI and reasons for discontinuation
Visit 0 V0 Potentially eligible participants will be identified by the Co-investigatorTG from Telephone triage assessment clinic bio-feedback clinicBFB and Multi-Disciplinary Meeting in PFU at St Thomas Hospital TG will introduce the research to eligible participants by contacting via telephone or during BFB
Eligible participants will be provided with an information pack with invitation letter participant information sheet PIS and two consent forms with a return label to post one of the consent forms back for record PIS will have all details and explanation of the aims methods anticipated benefits and possible risks of RI It will also have contact details of the Principle Investigator PI and the TG should eligible participants have any questions regarding the research trial before participating or to escalate concerns during participation Participants will have at least 48 hours to consider participation
Telephone Appointment TA This will scheduled at least 48 hours after the eligible participant has received the information pack TG will contact the eligible participant to discuss the trial in detail and answer any queries After discussion if eligible participant is happy to participate both consent forms will be signed Participants will then be asked to return one consent form to the department for record return label provided There is no obligation for eligible participants to give reasons for non-participation
Participants during the trial can withdraw anytime without giving reasons and return to routine care However data collected up to that point will be used to analyse current research as per PIS and consent form
After consent a participant journal PJ will be posted with instructions to fill it in PJ will record all participants medications and visits to healthcare professionals for constipation in the past three months It will also record bowel frequency two weeks before participants first face-to-face appointment
Visit 1 Face-to-face V1F Baseline assessment randomisation TPFUS and training in RI Participants will have medical history taken and undergo a physical examination of their back passage and vagina female participants Participants will be asked to hand over PJ filled at home and fill in four questionnaires which will help investigators assess impact of constipation on participants daily routine These are PAC-QOL PAC-SYM ICIQ-B and ODS-S as described in outcome measures
Participants will be randomly assigned 11 into two groups LV RI and HV RI Investigators will use online software Clinical trial randomisation tool by National Cancer Institute for randomisation Both LV and HV irrigation will be given a code by TG PI will perform randomisation and will perform allocation concealment using sealed envelopes
Participants will undergo TPFUS which is routinely performed on all our patients It uses inaudible sound waves to provide real-time static and dynamic multi-compartmental pelvic floor assessment of anatomical and functional aspects
The RI systems used in our unit are commercially available on prescription in National Health Service NHS practice Participants will receive training on using RI system from our Nurse Specialist and will be provided equipment to commence RI at home from the next day Participants will be shown how to record the frequency and volume of RI in the PJ and record any side effects such as pain bleeding etc
Participants will be contacted via telephone one week later to check for any issues If necessary investigators will arrange another training
Visit 2- face to face V2F This appointment will be three months after starting RI where participants will fill in outcome questionnaires as in previous visit and PJ will be collected This will end participation in the research trial and participants will return to routine care in our department
During 3-month follow-up participants may be withdrawn from the trial if become lost to follow-up after at least three failed attempts by TG to make contact via at least two different methods eg telephone email and letter choose to withdraw and do not wish to participate in follow-up data collection or lose capacity
The interventions LV and HV RI proposed are those already being offered to patients with CC secondary to ED in the Pelvic Floor UnitPFU St Thomas Hospital and many specialist centres globally All interventions pose acceptable risks TPFUS has been performed routinely in most specialist centres and is considered safe RI has proven to be a low-risk intervention and has been widely used for a variety of ED Serious adverse events SAE are rare with one study reporting two non-fatal bowel perforations out of approximately 110000 irrigation therapy Other possible side effects include rectal pain bleeding painful haemorrhoids and anal fissure A recent study reported an overall adverse event AE rate of 22 with all minor and reversible events considered
This trial is categorised as Type A ie no higher than the risk of standard medical care
Any AE or SAE reported by participant will be reported to the sponsor and Ethical committee by the PI The PI may take urgent safety measures to ensure the safety and protection of the participants The PI will send the Annual Progress Report to the sponsor and Ethical committee
If the PI determines that is it within the best interests of the participants to terminate the study written notification will be given to the sponsor following which participants will be returned to the routine NHS care
The research team in the PFU will be meeting every two weeks A trial risk assessment will be conducted in collaboration with the PI and an appropriate trial monitoring and auditing plan will be produced This will be authorised by the sponsor
PAC-QOL comprises of 28 questions scored 0-4 Average score of the non-missing questions is calculated by total score divided by number of questions responded is taken as participant score out of 4 Considering improvement in score of 10 as clinically relevant we calculated sample size keeping level of significance as 5 power as 90 and standard deviation of 08 in low-volume RI and 07 in high-volume RI groups as reported by Emmett CC et al Adjusting for loss to follow up of 10 we will need 83 participants in each group However should there be a greater than 10 dropout rate which we do not feel will be the case we will then recruit more participants to be able to analyse with a significance of 5 and power of 90
Primary outcome Investigators plan to conduct intention to treat analysis to compare the two types of RI at the end of 3 months Difference in improvement in PAC-QOL score will be tested using paired sample t-test Results will be reported as means along with standard deviations of difference in pre and post rectal irrigation for both groups and the mean difference of two interventions along with 95 confidence interval with p-value less than 005 will be taken as statistically significant
Secondary outcomes Investigators plan to conduct stratified analysis based upon findings on TPFUS anatomical vs functional causes of CC secondary to evacuation disorders Compliance to RI will be shown via proportion of participants using it at the end of 3 months Adverse effects from RI will be presented as frequencies Appropriate regression models will be developed to determine the influence of pre-treatment characteristics on the success of RI in all sub-groups Analysis will be performed using Statistical Package for the Social Sciences which is an online software platform where P 005 will be taken to indicate statistical significance
Investigators plan to conduct interim analysis at half the required sample size At this point the efficacy outcome will be evaluated and if the difference between two types of RI is statistically significant enough to reach p-value of 001 then that would be considered as sufficient evidence to establish the superiority of one irrigation system over another and continuing the trial further would not be justified
In the event of a required protocol amendment details will be submitted to the sponsor for authorisation
Data Protection Upon recruitment identifiable participant data IPD will be collected on paper CRF to contact participants CRF will be stored in locked cabinets while electronic data in a password protected filePPF on Microsoft access MA Only PI and TG will have access to IPD
TG will generate and assign a unique trial registration code UTRC to each participant Each participants data will be collected and stored against the UTRC pseudonymization CRF will be kept in locked cabinets while electronic data will be recorded in PPF on MA The participants general practitioner will be informed of their participation after obtaining consent
After data collection has ended TG will create a copy of collected data without the UTRC in a PPF on Microsoft Access thus completely anonymising data which will be emailed to the Statistician via encrypted email for analysis
This study is sponsored by Guys and St Thomas NHS Foundation Trust GSTFT and indemnity is provided through NHS indemnity for clinical negligence GSTFT is a member of the clinical Negligence Scheme for Trusts
The project will be under PI and sponsor The project will be overseen by PI and co-Investigators The role of the PI will be to provide overall supervision of the study on behalf of the sponsor to ensure that research trial is conducted in accordance with the principles of Good Clinical Practice GCP relevant regulations
A study launch meeting will be conducted This will include training in the trial protocol data collection randomisation and taking informed consent
The participants will not be identifiable with regards to any future publications After trial completion the pseudonymized records will be kept for a further five years and archived with Iron Mountain All IPD will also be archived for a period of five years in locked cabinets in the Pelvic Floor Unit at St Thomas Hospital therefore no third party will have access to it At the end of the five-year retention period permission will be obtained in writing from the sponsor prior to destruction of this material
Once results are available they will first be presented in a departmental meeting followed by submission of a summary to health research authority A brief summary of the outcomes will be posted to the participants Finally results will be submitted to scientific journals or presented at a conference not involving any IPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 324658 | OTHER | IRAS | None |