Low Anterior Resection SyndromeTraLARSNCT06796296
Transanal Irrigation for Low Anterior Resection Syndrome
A study testing Transanal Irrigation (TAI) in people with Low Anterior Resection Syndrome and Rectal Cancer Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome, Rectal Cancer Surgery, Insomnia
- What is being tested?
- Transanal Irrigation (TAI)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2025to 31 Dec 2029
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years and above.
- Patients who have undergone low or ultra-low anterior resection surgery for rectal cancer (within 15cm from the anal verge).
- Patients at least 24 months post-surgery without stoma.
- Patients evaluated with a major LARS score.
- Patients who comprehend and have the ability to participate in this clinical trial.
Who cannot join
- Patients with recurrent colorectal cancer.
- Patients with concomitant metastatic colorectal cancer.
- Patients requiring permanent colostomy.
- Patients who have undergone postoperative cancer radiation therapy.
- Patients with underlying conditions not controlled by internal medical treatment.
- Patients with inflammatory bowel disease (IBD).
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- Patients with symptoms of constipation or diarrhea not controlled by medication.
- Patients with preoperative symptoms of fecal incontinence.
- Patients allergic to the investigational drug.
- Patients deemed unsuitable for clinical trial participation by the principal investigator and study personnel.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, Jongro-gu, 03080
Seung-Bum Ryoo, +82-2-2072-4847, sbryoomd@gmail.com
About this study
Official title: The Safety and Efficacy of Transanal Irrigation in Patients from Low Anterior Resection Syndrome After Rectal Cancer Surgery : a Multicenter Prospective Randomized Controlled Trial (TraLARS Study)
The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates.
Preservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (ARS). Particularly in the case of low rectal cancer, it often manifests as Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, generally persisting in a significant degree for 1-2 years, with some improvement over time. However, for many patients, LARS remains a lifelong challenge, significantly impacting their quality of life. Nighttime symptoms of LARS, in particular, have a profound effect on sleep quality, potentially leading to a decline in overall quality of life.
Read more
Currently, there is no definitive method to completely cure LARS, and the available approaches focus on empirical treatments or short-term symptom control using medications such as loperamide.
Loperamide directly affects the neuromuscular system of the intestine, reducing its motility. This prolongs the time food stays in the intestine, allowing sufficient absorption of moisture and electrolytes, consequently reducing symptoms of diarrhea. Loperamide is available in two forms: loperamide oxide and loperamide hydrochloride. While loperamide oxide products like Arestal® were prescribed by doctors until August 2017, the approval was revoked, leaving loperamide hydrochloride as the only form used domestically. It comes in a single product containing 2 mg of loperamide hydrochloride and a combination product with 0.25 mg of loperamide hydrochloride, a sterilizing agent in the intestine (e.g., acrylonitrile, berberine), and an antispasmodic.
Transanal irrigation (TAI) is a method where patients self-administer water into the rectum through an enema, physically cleansing the anus and rectum. This technique is often used for patients with chronic constipation or fecal incontinence. TAI has proven beneficial, particularly in improving symptoms for patients experiencing bowel dysfunction following sphincter-preserving surgery, especially for those who underwent low anterior resection.
However, there is currently no research on the utility and safety of TAI for LARS patients, specifically addressing whether it can improve the nighttime symptoms associated with LARS syndrome and enhance sleep quality. Therefore, this study aims to investigate the impact of TAI on the symptoms of LARS syndrome.
- Being tested
- Transanal Irrigation (TAI)
- Keywords
- Transanal irrigation, Low anterior resection syndrome
- Medical subject headings
- Low Anterior Resection Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal Irrigation (TAI)Procedure or surgery
The combination of transanal irrigation (TAI) and Loperamide involves administering Loperamide orally, with a daily dosage of 2mg. This is complemented by the use of TAI, a method in which patients self-administer water into the rectum through an enema, aiming to enhance bowel management and potentially alleviate sysmptoms associated with LARS
| Study group | Role | What they receive |
|---|---|---|
| Loperamide group | No intervention | The group only takes loperamide in the evening (2mg once daily orally) |
| Loperamide + Transanal irrigation | Experimental | The group takes Loperamide daily and undergoes transanal irrigation once or twice a week Receives: Procedure: Transanal Irrigation (TAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of major LARS
Patients are requested to answer the LARS score questionnaires at inclusion (0 week) and 4 weeks after intervention at the outpatient clinic.
The score ranges from 0 to 42, with 0-20 signifying no LARS, 21-29 signifying minor LARS, and 30-42 signifying major LARS.
Only patients with major LARS at 0 week are enrolled. Re-measure the LARS score at week 4 to see the rate of improvement (minor LARS or no LARS) in major LARS in both groups.
Measured: 4 weeks
Secondary outcomes (3)
The LARS (Low Anterior Resection Syndrome) score
A survey is conducted, scoring patient's symptoms related to LARS. It includes the LARS score with night-time symptoms.
Measured: 4 weeks
Insomnia Severity Index score in Korean Validation
A survey is conducted, scoring patient's symptoms related to Insomnia.
Measured: 4 weeks
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
A survey is conducted, scoring patient's symptoms related to LARS and quality of life.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796296
- Sponsor's protocol ID
- D-2310-121-1479
- Acronym
- TraLARS
- Status last verified
- Nov 2024
- First submitted
- 13 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Transanal Irrigation in Patients from Low Anterior Resection Syndrome After Rectal Cancer Surgery : a Multicenter Prospective Randomized Controlled Trial (TraLARS Study)
- ClinicalTrials.gov ID
- NCT06796296
- Acronym / sponsor ID
- TraLARS / D-2310-121-1479
- Keywords
- Transanal irrigation, Low anterior resection syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Jan 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 preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates.
Preservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (ARS). Particularly in the case of low rectal cancer, it often manifests as Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, generally persisting in a significant degree for 1-2 years, with some improvement over time. However, for many patients, LARS remains a lifelong challenge, significantly impacting their quality of life. Nighttime symptoms of LARS, in particular, have a profound effect on sleep quality, potentially leading to a decline in overall quality of life.
Currently, there is no definitive method to completely cure LARS, and the available approaches focus on empirical treatments or short-term symptom control using medications such as loperamide.
Loperamide directly affects the neuromuscular system of the intestine, reducing its motility. This prolongs the time food stays in the intestine, allowing sufficient absorption of moisture and electrolytes, consequently reducing symptoms of diarrhea. Loperamide is available in two forms: loperamide oxide and loperamide hydrochloride. While loperamide oxide products like Arestal® were prescribed by doctors until August 2017, the approval was revoked, leaving loperamide hydrochloride as the only form used domestically. It comes in a single product containing 2 mg of loperamide hydrochloride and a combination product with 0.25 mg of loperamide hydrochloride, a sterilizing agent in the intestine (e.g., acrylonitrile, berberine), and an antispasmodic.
Transanal irrigation (TAI) is a method where patients self-administer water into the rectum through an enema, physically cleansing the anus and rectum. This technique is often used for patients with chronic constipation or fecal incontinence. TAI has proven beneficial, particularly in improving symptoms for patients experiencing bowel dysfunction following sphincter-preserving surgery, especially for those who underwent low anterior resection.
However, there is currently no research on the utility and safety of TAI for LARS patients, specifically addressing whether it can improve the nighttime symptoms associated with LARS syndrome and enhance sleep quality. Therefore, this study aims to investigate the impact of TAI on the symptoms of LARS syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loperamide group | No intervention | –The group only takes loperamide in the evening (2mg once daily orally) |
| Loperamide + Transanal irrigation | Experimental | Procedure: Transanal Irrigation (TAI)The group takes Loperamide daily and undergoes transanal irrigation once or twice a week |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 19 years and above.
- Patients who have undergone low or ultra-low anterior resection surgery for rectal cancer (within 15cm from the anal verge).
- Patients at least 24 months post-surgery without stoma.
- Patients evaluated with a major LARS score.
- Patients who comprehend and have the ability to participate in this clinical trial.
Key exclusion criteria (10 listed)
- Patients with recurrent colorectal cancer.
- Patients with concomitant metastatic colorectal cancer.
- Patients requiring permanent colostomy.
- Patients who have undergone postoperative cancer radiation therapy.
- Patients with underlying conditions not controlled by internal medical treatment.
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 Irrigation (TAI)The combination of transanal irrigation (TAI) and Loperamide involves administering Loperamide orally, with a daily dosage of 2mg. This is complemented by the use of TAI, a method in which patients self-administer water into the rectum through an enema, aiming to enhance bowel management and potentially alleviate sysmptoms associated with LARS | Procedure or surgery | Loperamide + Transanal irrigation |
Primary outcome
The proportion of major LARS
Time frame: 4 weeks
Patients are requested to answer the LARS score questionnaires at inclusion (0 week) and 4 weeks after intervention at the outpatient clinic. The score ranges from 0 to 42, with 0-20 signifying no LARS, 21-29 signifying minor LARS, and 30-42 signifying major LARS. Only patients with major LARS at 0 week are enrolled. Re-measure the LARS score at week 4 to see the rate of improvement (minor LARS or no LARS) in major LARS in both groups.
3 secondary outcomes
The LARS (Low Anterior Resection Syndrome) score
Time frame: 4 weeks
Insomnia Severity Index score in Korean Validation
Time frame: 4 weeks
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 4 weeks
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 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
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.
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 (TAI) in people with Low Anterior Resection Syndrome and Rectal Cancer Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Jan 2025. 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 South Korea. 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 Seung-Bum Ryoo (+82-2-2072-4847, sbryoomd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of major LARS (time frame: 4 weeks). 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 28 Jan 2025.