Low Anterior Resection SyndromeNCT05920681
Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial
A study testing Transanal irrigation in people with Low Anterior Resection Syndrome, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
Trial summary
Introduction: About 50% of patients who undergo rectal resection (mostly as a treatment for rectal cancer) suffer from various and partly severe functional problems, despite the preservation of the anal fold. These complaints are summarized as low anterior resection syndrome (LARS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Transanal irrigation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 18 Jun 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Subject is an adult (≥ 18 years);
- Agrees to participate in a study;
- A low anterior resection (robotic, laparoscopic or open) was performed (anastomosis up to 5-7 cm from the anocutaneous line when assessed with a finger or endo(recto)scope);
- >12 months have passed since the operation or the closure of the ileostomy (if formed);
- No anastomotic leak or stenosis (assessed clinically, during examination, and/or proctogram);
- LARS >30 points (major LARS).
Who cannot join
- Tumor recurrence/progression
- Pregnancy
- Diagnosed with inflammatory bowel disease (ICD codes K50-59).
- Side-to-end anastomosis
- Palliative care
- Will not be able to perform irrigation
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
National Cancer Institute
Vilnius, 14186
Audrius Dulskas, +37067520094, audrius.dulskas@gmail.com
About this study
Introduction: About 50% of patients who undergo rectal resection (mostly as a treatment for rectal cancer) suffer from various and partly severe functional problems, despite the preservation of the anal fold. These complaints are summarized as low anterior resection syndrome (LARS). So far, there are no randomized clinical trials that would definitively confirm or deny the hypothesis regarding the most effective treatment for LARS.
Objectives: To evaluate whether transanal irrigation improves bowel function and quality of life in patients after rectal resection compared with the best supportive care.
Read more
Methods and analysis: Patients who have undergone low anterior resection will be approached for this study. During the patient's visit, we will assess their complaints regarding defecation problems, as well as any deterioration in their overall quality of life. To gather this information, we will have the patients fill out questionnaires such as the LARS (Low Anterior Resection Syndrome) and Wexner scale, along with quality of life questionnaires. Questionnaires and scales will be filled out again during the visit every 3 months for 1 year.
Discussion: This multicentre, randomized controlled trial will lead to a better understanding of LARS treatment. Moreover, it will be hypothesis generating and inform areas needing future prospective studies.
Read the detailed description
This is a multicenter randomized clinical trial. The main objective of this clinical trial is to evaluate whether transanal irrigation improves bowel function and quality of life in patients following low anterior resection best supportive care. This will be accomplished by recording the patient's complaints (defecation, urination problems, deterioration of quality of life) after the operation, filling the LARS score (3,112), Wexner scale (123), quality of life questionnaires (EORTC CR29 (134) and Measure yourself medical outcomes profile (MYMOP)) (15) with additional questions: Would you advice this treatment to anybody else? Did your quality of live improve? Did the bowl function improve? Are you satisfied with the treatment? Did you expect the treatment would help? These questions will be rated from 0 to 5. All will be filled in again during the visit every 3 months for 12 months.
Study population All patients who developed LARS and meet the inclusion criteria will be offered participation in this clinical trial.
Recruitment Patients who have developed LARS and meet the inclusion criteria will be offered participation in this clinical trial upon consultation with an abdominal surgeon or surgeon at the National Cancer Institute clinic (or any other participating center). The patient will be given time to think as much as necessary, and all questions related to the clinical trial will be answered. The patient's decision to participate or not to participate in the study will not have any effect on his further treatment and or surveillance. Patients who have consented and signed the personal information form and the consent form will be included in the study.
Interventions During the study, transanal irrigations will be used -- which are considered safe procedures that do not pose additional risks to the patient.
TAI (Transanal irrigation):
Transanal irrigation will be applied to patients who will enter the experimental group. The patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip (cone catheter) lubricated with lubricant. The TAI bag is filled with warm water - d it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus - the cone catheter is inserted (the starting volume is 500ml of water and it evuantuale over 3-4 week period can be increased up to 1L). The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily.
The patients will be instructed by the treating physician and will be contacted within 3-4 weeks on the course of the procedure.
In case of bleeding or abdominal pain, patients were instructed to contact the caregiver. For all other questions regarding TAI, the instructor could be contacted during office hours.
Best supportive care:
The control group will receive best supportive care (: diet modification - low fiber diet and personal recommendations were given), medications (bulky-forming agents and Loperamide®Loperamidum) if needed, diapers, etc ). All patients were instructed regarding the pelvic floor muscle training (Kegel exercise).
No patients received biofeedback therapy or any other interventions such as sacral nerve stimulation or percutaneous tibial nerve stimulation.
Assessments Data collection will take place during the patient visit . Demographic and clinical examination data will be collected from the medical documentation at the research center. During the visit, the patient's complaints (defecation, deterioration of quality of life) will be recorded after the operation, LARS, Wexner scale, quality of life questionnaires will be filled during the visit. Questionnaires and scales will be filled again during the visit every 3 months for 12 months. Other tests that will be performed during the visit will be long-term follow-up tests, an integral part of the treatment, not related to the clinical trial.
Sample size
A sample size of 40 is planned (an improvement of 5 points on the LARS scale):
- 20 transanal irrigation group (experimental)
- 20 best supportive care group (control). To demonstrate a 5 points difference (with 80% certainty) between intervention group and control, 34 patients required to be included (17 in each study arm). Taking into account drop off of 20% at least 20 patients per group will be needed. The primary endpoint was LARS score analysed by unpaired t test.After the statistical analysis , after conducting the research with this sample, the results will be statistically reliable for the Lithuanian population Outcome measures The objectives of the trial are to evaluate in what proportion of patients (percentage) transanal irrigation and in what proportion of patients (percentage) the best supportive treatment reduces the symptoms of LARS score (change in absolute score). Compare the results and evaluate the statistical reliability. The secondary outcomes would be assessing the change in single LARS score's items.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Transanal irrigation, Best supportive care
- Keywords
- Low Anterior Resection Syndrome, Transanal irrigation, Fecal Incontinence, Colorectal Surgery, Quality of Life, Randomized Controlled Trial
- Medical subject headings
- Low Anterior Resection Syndrome, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal irrigationProcedure or surgery
The patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip lubricated with lubricant. The TAI bag is filled with warm water - d it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus. The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily.
Best supportive careCombination product
Diet modification, Loperamidum if needed, diapers, etc.
| Study group | Role | What they receive |
|---|---|---|
| Transanal irrigation group | Experimental | Transanal irrigation will be applied to patients who will enter the experimental group. The patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip lubricated with lubricant. The TAI bag is filled with warm water - it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus. The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily. Receives: Procedure: Transanal irrigation |
| Best supportive care group | Active comparator | The control group will receive best supportive care (diet modification, Loperamidum if needed, diapers, etc).
Loperamidum Dosage form: Loperamide Tablets (2mg of loperamide hydrochloride.). Dosage: Initial dose - 2 tablets immediately, then - 1 tablet after each loose stool, but not earlier than 2-3 hours after the initial dose. Do not exceed the maximum daily dose - no more than 6 tablets for adults (maximum daily dose 12 mg). Receives: Combination Product: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients for whom transanal irrigation reduced LARS symptom scores
Assess the proportion of patients with transanal irrigation that reduces the symptoms of LARS.
Measured: 1 year
Proportion of patients for whom best supportive treatment reduced LARS symptom scores
Assess the proportion of patients with best supportive care that reduces the symptoms of LARS.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start18 Jun 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Anterior Resection SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals participating in this study will be randomly divided into groups 1 and 2 by randomization. The probability of falling into one or the other group is equal. * Group 1. This is a group of patients who will be subjected to transanal irrigation (experimental). * Group B. This is a group of patients who will receive only the best currently in use maintenance treatment (control).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrius Dulskas, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920681
- Sponsor's protocol ID
- LARSTAI
- Status last verified
- Nov 2023
- First submitted
- 17 Jun 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Civilka I, Klimovskij M, Aleinikov A, Christensen P, Samalavicius NE, Sakalauskaite M, Dulskas A. Transanal irrigation for low anterior resection syndrome treatment: international multicentre randomized clinical trial. BJS Open. 2026 May 12;10(3):zrag022. doi: 10.1093/bjsopen/zrag022.
PubMed 42141911Klimovskij M, Civilka I, Aleinikov A, Aukstikalnis T, Christensen P, Dulskas A. Is transanal irrigation the best treatment possibility for low anterior resection syndrome? A multicenter, randomized clinical trial: study protocol. Front Surg. 2024 May 13;11:1384815. doi: 10.3389/fsurg.2024.1384815. eCollection 2024.
PubMed 38803549
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05920681
- Acronym / sponsor ID
- LARSTAI
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- Low Anterior Resection Syndrome, Transanal irrigation, Fecal Incontinence, Colorectal Surgery, Quality of Life, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Study start
- 18 Jun 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 27 Jun 2023 (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.
Introduction: About 50% of patients who undergo rectal resection (mostly as a treatment for rectal cancer) suffer from various and partly severe functional problems, despite the preservation of the anal fold. These complaints are summarized as low anterior resection syndrome (LARS). So far, there are no randomized clinical trials that would definitively confirm or deny the hypothesis regarding the most effective treatment for LARS.
Objectives: To evaluate whether transanal irrigation improves bowel function and quality of life in patients after rectal resection compared with the best supportive care.
Methods and analysis: Patients who have undergone low anterior resection will be approached for this study. During the patient's visit, we will assess their complaints regarding defecation problems, as well as any deterioration in their overall quality of life. To gather this information, we will have the patients fill out questionnaires such as the LARS (Low Anterior Resection Syndrome) and Wexner scale, along with quality of life questionnaires. Questionnaires and scales will be filled out again during the visit every 3 months for 1 year.
Discussion: This multicentre, randomized controlled trial will lead to a better understanding of LARS treatment. Moreover, it will be hypothesis generating and inform areas needing future prospective studies.
Detailed description
This is a multicenter randomized clinical trial. The main objective of this clinical trial is to evaluate whether transanal irrigation improves bowel function and quality of life in patients following low anterior resection best supportive care. This will be accomplished by recording the patient's complaints (defecation, urination problems, deterioration of quality of life) after the operation, filling the LARS score (3,112), Wexner scale (123), quality of life questionnaires (EORTC CR29 (134) and Measure yourself medical outcomes profile (MYMOP)) (15) with additional questions: Would you advice this treatment to anybody else? Did your quality of live improve? Did the bowl function improve? Are you satisfied with the treatment? Did you expect the treatment would help? These questions will be rated from 0 to 5. All will be filled in again during the visit every 3 months for 12 months.
Study population All patients who developed LARS and meet the inclusion criteria will be offered participation in this clinical trial.
Recruitment Patients who have developed LARS and meet the inclusion criteria will be offered participation in this clinical trial upon consultation with an abdominal surgeon or surgeon at the National Cancer Institute clinic (or any other participating center). The patient will be given time to think as much as necessary, and all questions related to the clinical trial will be answered. The patient's decision to participate or not to participate in the study will not have any effect on his further treatment and or surveillance. Patients who have consented and signed the personal information form and the consent form will be included in the study.
Interventions During the study, transanal irrigations will be used -- which are considered safe procedures that do not pose additional risks to the patient.
TAI (Transanal irrigation):
Transanal irrigation will be applied to patients who will enter the experimental group. The patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip (cone catheter) lubricated with lubricant. The TAI bag is filled with warm water - d it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus - the cone catheter is inserted (the starting volume is 500ml of water and it evuantuale over 3-4 week period can be increased up to 1L). The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily.
The patients will be instructed by the treating physician and will be contacted within 3-4 weeks on the course of the procedure.
In case of bleeding or abdominal pain, patients were instructed to contact the caregiver. For all other questions regarding TAI, the instructor could be contacted during office hours.
Best supportive care:
The control group will receive best supportive care (: diet modification - low fiber diet and personal recommendations were given), medications (bulky-forming agents and Loperamide®Loperamidum) if needed, diapers, etc ). All patients were instructed regarding the pelvic floor muscle training (Kegel exercise).
No patients received biofeedback therapy or any other interventions such as sacral nerve stimulation or percutaneous tibial nerve stimulation.
Assessments Data collection will take place during the patient visit . Demographic and clinical examination data will be collected from the medical documentation at the research center. During the visit, the patient's complaints (defecation, deterioration of quality of life) will be recorded after the operation, LARS, Wexner scale, quality of life questionnaires will be filled during the visit. Questionnaires and scales will be filled again during the visit every 3 months for 12 months. Other tests that will be performed during the visit will be long-term follow-up tests, an integral part of the treatment, not related to the clinical trial.
Sample size
A sample size of 40 is planned (an improvement of 5 points on the LARS scale):
- 20 transanal irrigation group (experimental)
- 20 best supportive care group (control). To demonstrate a 5 points difference (with 80% certainty) between intervention group and control, 34 patients required to be included (17 in each study arm). Taking into account drop off of 20% at least 20 patients per group will be needed. The primary endpoint was LARS score analysed by unpaired t test.After the statistical analysis , after conducting the research with this sample, the results will be statistically reliable for the Lithuanian population Outcome measures The objectives of the trial are to evaluate in what proportion of patients (percentage) transanal irrigation and in what proportion of patients (percentage) the best supportive treatment reduces the symptoms of LARS score (change in absolute score). Compare the results and evaluate the statistical reliability. The secondary outcomes would be assessing the change in single LARS score's items.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Individuals participating in this study will be randomly divided into groups 1 and 2 by randomization. The probability of falling into one or the other group is equal. * Group 1. This is a group of patients who will be subjected to transanal irrigation (experimental). * Group B. This is a group of patients who will receive only the best currently in use maintenance treatment (control).
| Arm | Type | Receives |
|---|---|---|
| Transanal irrigation group | Experimental | Procedure: Transanal irrigationTransanal irrigation will be applied to patients who will enter the experimental group. The patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip lubricated with lubricant. The TAI bag is filled with warm water - it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus. The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily. |
| Best supportive care group | Active comparator | Combination Product: Best supportive careThe control group will receive best supportive care (diet modification, Loperamidum if needed, diapers, etc). Loperamidum Dosage form: Loperamide Tablets (2mg of loperamide hydrochloride.). Dosage: Initial dose - 2 tablets immediately, then - 1 tablet after each loose stool, but not earlier than 2-3 hours after the initial dose. Do not exceed the maximum daily dose - no more than 6 tablets for adults (maximum daily dose 12 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is an adult (≥ 18 years);
- Agrees to participate in a study;
- A low anterior resection (robotic, laparoscopic or open) was performed (anastomosis up to 5-7 cm from the anocutaneous line when assessed with a finger or endo(recto)scope);
- >12 months have passed since the operation or the closure of the ileostomy (if formed);
- No anastomotic leak or stenosis (assessed clinically, during examination, and/or proctogram);
Key exclusion criteria (6 listed)
- Tumor recurrence/progression
- Pregnancy
- Diagnosed with inflammatory bowel disease (ICD codes K50-59).
- Side-to-end anastomosis
- Palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transanal irrigationThe patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip lubricated with lubricant. The TAI bag is filled with warm water - d it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus. The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily. | Procedure or surgery | Transanal irrigation group |
| Best supportive careDiet modification, Loperamidum if needed, diapers, etc. | Combination product | Best supportive care group |
Primary outcome
Proportion of patients for whom transanal irrigation reduced LARS symptom scores
Time frame: 1 year
Assess the proportion of patients with transanal irrigation that reduces the symptoms of LARS.
Proportion of patients for whom best supportive treatment reduced LARS symptom scores
Time frame: 1 year
Assess the proportion of patients with best supportive care that reduces the symptoms of LARS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 42141911Civilka I, Klimovskij M, Aleinikov A, Christensen P, Samalavicius NE, Sakalauskaite M, Dulskas A. Transanal irrigation for low anterior resection syndrome treatment: international multicentre randomized clinical trial. BJS Open. 2026 May 12;10(3):zrag022. doi: 10.1093/bjsopen/zrag022.
- Derived from this study: PubMed 38803549Klimovskij M, Civilka I, Aleinikov A, Aukstikalnis T, Christensen P, Dulskas A. Is transanal irrigation the best treatment possibility for low anterior resection syndrome? A multicenter, randomized clinical trial: study protocol. Front Surg. 2024 May 13;11:1384815. doi: 10.3389/fsurg.2024.1384815. eCollection 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal irrigation in people with Low Anterior Resection Syndrome, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrius Dulskas, PhD ((85) 219 0947, audrius.dulskas@nvi.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients for whom transanal irrigation reduced LARS symptom scores (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920681, which also lists 2 linked publications.
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 8 Nov 2023.