GastroenterologyMINIGONCT06923150
A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients
An observational study of Gastroenterology and LARS - Low Anterior Resection Syndrome, run by Qufora A/S at 9 sites in France.
Trial summary
The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenterology, LARS - Low Anterior Resection Syndrome, Rectal Cancer
- How many people
- 78 participants
- Where
- 9 sitesFrance
- Study dates
- 18 Jun 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: minor and major LARS patients LARS score >= 25
Who may be able to join
- Adult aged from 18 years
- Patients electively treated for rectal cancer with a low anterior resection
- Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
- LARS score >= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)
- Adult for whom previous conservative treatments were started for at least a month
- Mental and physical capability of the patient to handle the MiniGo by himself.
- Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice
- Patient affiliated to the health social security system
Who cannot join
- Contra-indication to use TAI
- Former use of TAI (post colo-rectal surgery)
- Clinically relevant stenosis
- Current metastatic disease or local recurrence
- Ongoing chemotherapy
- Postoperative radiotherapy for rectal cancer
Show all 16Show fewer
- History of diarrhoeal disease
- Inflammatory bowel disease
- Dementia
- Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.
- Patient with cancer recurrence
- Patient with a life expectancy < 1 year
- Participating to another clinical trial for the treatment of LARS symptom
- Ongoing pelvic floor rehabilitation/biofeedback
- Pregnancy or intention to become pregnant during the trial period
- Inability and unwillingness to give informed consent
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Charles SABBAGH
- Recruiting
CHU Besançon
Besançon, 25030
Zaher LAKKIS
- Recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Quentin DENOST
- Recruiting
CHU Grenoble
La Tronche, 38700
Jean-Luc FAUCHERON
- Not yet recruiting
CHU Timone
Marseille, 13005
Diane MEGE
- Recruiting
CHU de NANTES, Hôtel Dieu
Nantes, 44093
Emilie DUCHALAIS DASSONNEVILLE
- Not yet recruiting
CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE
Pessac, 33604
Benjamin FERNANDEZ
- Not yet recruiting
CH Lyon Sud
Pierre-Bénite, 69495
Eddy COTTE
- Recruiting
CHU Charles Nicolle - Rouen
Rouen, 76 031
Valérie BRIDOUX
About this study
The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.
- Keywords
- LARS, Transanal Irrigation, Minigo, rectal cancer
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAI + SOC | Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments | |
| SOC | Standard of Care (SOC) conservative treatments: dietary management, counselling, medication: anti-diarrheic or constipation treatment according to the prescription following usual practice, and food supplement excluding: suppository, ano-rectal stimulation, physiotherapy small enemas, etc… |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARS score difference
The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.
Measured: 3-month follow-up
Secondary outcomes (15)
efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks
LARS difference score between inclusion and 6-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals
Measured: 6-week follow-up
QoL with the EORTC QLQ-C30 EORTC QLQ-CR29
EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 3-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals.
Also, statistical tests of superiority will be performed comparing EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences between inclusion and 3-month follow-up between interventional arm and control arm
Measured: 3-month follow- up
change (reduction) of symptoms and consequences
To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6 and 12 weeks The number and the proportion of patients with each item of the LARS international consensus definition at 6 and 12 weeks will be calculated.
Also, the proportion of patients who are considered as having no LARS at 6 and 12 weeks will be calculated with a confidence interval
Measured: 6 weeks and 12 weeks
patient satisfaction
to assess the patient satisfaction at 6 and 12 weeks, The proportion of patients satisfied by the treatment evaluated with the 5-point Likert Scale at 6 and 12 weeks will be calculated with a confidence interval.
Measured: 6 weeks and 12 weeks
compliance of the patient to the treatmen
to assess the compliance of the patient to the treatment at 6 and 12 weeks Compliance with the treatment during the 6 and 12 weeks of study with the number of days of MiniGo use per week will be calculated using descriptive statistics and confidence intervals
Measured: 6 weeks and 12 weeks
incontinence anal score
To access the incontinence anal score at 12 weeks Wexner difference score between inclusion and 12-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals.
Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-week follow-up between interventional arm and control arm.
Measured: 12 weeks
reduction of defecations per day and night
To assess the reduction of defecations per day and night The mean number of defecations per day and per night during the week before the randomisation and the week before the follow-up visit at 6 and 12 weeks will be calculated.
Measured: 6 weeks and 12 weeks
time spent on bowel management (in the toilets room)
To assess the time spent on bowel management (in the toilets room) Mean times spent in the toilets room per day the week before the randomisation and the week before the follow-up visit at 12 weeks will be calculated using descriptive statistics.
Measured: 12 weeks
patient health organization and resources needed
To evaluate the patient health organization and resources needed at 12 weeks Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics.
Measured: 12 weeks
improving the LARS score
to assess the efficacy on clinical symptom of Transanal Irrigation by MiniGo in improving the LARS score at 6, 9 and 12 months LARS difference score between inclusion and 6, 9 and 12-month follow-ups will be calculated using descriptive statistics and confidence intervals.
Measured: 6, 9 and 12 months
number of patients showing a change (reduction) of symptoms and consequences
To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6, 9 and 12 months The number and the proportion of patients with each item of the LARS international consensus definition at 6, 9 and 12 months will be calculated.
Also, the proportion of patients who are considered as having no LARS at 6, 9 and 12 months will be calculated with a confidence interval.
Measured: 6, 9 and 12 months
Preference of the patient and reason for it
To assess the preference of the patient and reason for it Proportion of patients who stay on TAI treatment for TAI arm and proportion of patients from SOC arm whose tries and stay on TAI will be calculated using confidence intervals. Description of reasons will be also presented.
Measured: 12 month follow-up
QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month
to assess the QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 12-month follow-ups will be calculated for each randomised arm using descriptive statistics and confidence intervals.
Measured: 12-month follow-up
incontinence anal score at 12 months
Wexner difference score between inclusion and 12-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals.
Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-month follow-up between interventional arm and control arm
Measured: 12-month follow-up
patient health organization and resources needed at 6, 9 and 12 months
Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics
Measured: 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start18 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenterologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qufora A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923150
- Sponsor's protocol ID
- 2023-A02656-39
- Acronym
- MINIGO
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients
- ClinicalTrials.gov ID
- NCT06923150
- Acronym / sponsor ID
- MINIGO / 2023-A02656-39
- Keywords
- LARS, Transanal Irrigation, Minigo, rectal cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Qufora A/SIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAI + SOC | – | –Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments |
| SOC | – | –Standard of Care (SOC) conservative treatments: dietary management, counselling, medication: anti-diarrheic or constipation treatment according to the prescription following usual practice, and food supplement excluding: suppository, ano-rectal stimulation, physiotherapy small enemas, etc… |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- minor and major LARS patients LARS score >= 25
Key inclusion criteria (8 listed)
- Adult aged from 18 years
- Patients electively treated for rectal cancer with a low anterior resection
- Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
- LARS score >= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)
- Adult for whom previous conservative treatments were started for at least a month
Key exclusion criteria (16 listed)
- Contra-indication to use TAI
- Former use of TAI (post colo-rectal surgery)
- Clinically relevant stenosis
- Current metastatic disease or local recurrence
- Ongoing chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LARS score difference
Time frame: 3-month follow-up
The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.
15 secondary outcomes
efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks
Time frame: 6-week follow-up
QoL with the EORTC QLQ-C30 EORTC QLQ-CR29
Time frame: 3-month follow- up
change (reduction) of symptoms and consequences
Time frame: 6 weeks and 12 weeks
patient satisfaction
Time frame: 6 weeks and 12 weeks
compliance of the patient to the treatmen
Time frame: 6 weeks and 12 weeks
incontinence anal score
Time frame: 12 weeks
reduction of defecations per day and night
Time frame: 6 weeks and 12 weeks
time spent on bowel management (in the toilets room)
Time frame: 12 weeks
patient health organization and resources needed
Time frame: 12 weeks
improving the LARS score
Time frame: 6, 9 and 12 months
number of patients showing a change (reduction) of symptoms and consequences
Time frame: 6, 9 and 12 months
Preference of the patient and reason for it
Time frame: 12 month follow-up
QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month
Time frame: 12-month follow-up
incontinence anal score at 12 months
Time frame: 12-month follow-up
patient health organization and resources needed at 6, 9 and 12 months
Time frame: 6, 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
Related trials for Gastroenterology
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Recruiting
A Dietitian-Driven Unified Nutritional Care Model (ADDUCE)
Hospitalized Adult Patients, Inpatient Internal Medicine Patients
RecruitingObservational study
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
Irritable Bowel Syndrome
Active, not recruiting
Applying the Intention-Action Framework to Specialty Referrals
Cardiology, Gastroenterology
Not yet recruitingObservational study
Assessing Knowledge, Attitudes, Trust, Perceived Usefulness, and Barriers to Using Artificial Intelligence (AI) in Gastroenterology Among Clinicians and Patients
AI and GIT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenterology and LARS - Low Anterior Resection Syndrome, run by Qufora A/S at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rogini Balachandran (+ 45 42 40 06 20, rob@qufora.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARS score difference (time frame: 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.