Rectal NeoplasmNCT07041515
Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome
A study testing Mobile app and standard in people with Rectal Neoplasm, run by National Cancer Center, Korea.
Trial summary
Low anterior resection syndrome refers to changes in bowel habits such as frequent defecation, urgent defecation, and fecal incontinence, which result in decreased bowel function. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rectal Neoplasm
- What is being tested?
- Mobile app and standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Jan 2032
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-70 years
- Patients scheduled for anal-sparing rectal resection or stomy repair diagnosed with rectal cancer (within 15 cm from Anal Verge)
- Patients with an expected survival period of 1 year or more
- Patients or their primary caregivers use smartphones (apps)
- Patients who are aware of their own status and can provide consent for this study
Who cannot join
- If you are receiving chemotherapy or radiotherapy at the time of consent
- If you are scheduled for major colectomy such as total colectomy or partial colectomy in addition to rectal resection
- If you cannot be contacted by phone
- If you cannot read and understand Korean
- If you cannot provide consent based on clear and sufficient information
About this study
Official title: A Randomized, Multicenter Clinical Trial to Evaluate the Feasibility and Utility of a Postoperative Management App for Patients Undergoing Rectal Resection
Low anterior resection syndrome refers to changes in bowel habits such as frequent defecation, urgent defecation, and fecal incontinence, which result in decreased bowel function. It occurs very commonly after surgery for colorectal cancer, especially rectal cancer, and symptoms appear severely immediately after surgery, followed by a recovery process. It is known that symptoms improve significantly after one year of surgery, but in some patients, symptoms persist, which significantly affects the quality of life and causes social problems.
There is no established treatment method for low anterior resection syndrome, and accurate evaluation and customized treatment are required according to the patient's surgical or radiotherapy treatment content and symptoms. It is also important to monitor the change in symptoms during the treatment process, and a customized step-by-step treatment strategy for such patients is required. However, such a customized step-by-step treatment strategy for such patients is very complex, and there are no clear guidelines to date, and the research design for some clinical trials has been recently reported.
The purpose of this study was to develop an app-based Patient-Reported Outcome (PRO) standardized questionnaire for patients after rectal cancer surgery to systematically collect and monitor symptom information, establish a multidisciplinary management plan tailored to patients, and provide education and treatment to improve the quality of life of rectal cancer survivors. A management program utilizing a research device (app) can reduce the incidence of Major LARS after rectal cancer surgery compared to standard treatment.
- Conditions
- Rectal Neoplasm
- Being tested
- Mobile app, standard
- Keywords
- rectal neoplasm, low anterior resection syndrome, Patient Reported Outcome
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appOther
This study will be conducted in two stages, recruiting patients scheduled for low anterior resection and those scheduled for ostomy restoration after low anterior resection. The pilot stage study will recruit 20 subjects without randomization to evaluate the feasibility of the management program app, and the second stage study will be a parallel experimental-control study, recruiting approximately 300 research participants, 150 from each group.
Patients scheduled for ostomy repair after low anterior resection and low anterior resection are required to fill out a consent form the day before, and participants are randomly assigned to one of two groups in a 1:1 ratio: the experimental group and the control group. Both groups are randomly assigned to four surveys. The types are three quality of life assessment questionnaires (QOL (EORTC QLQ-C30, CR-29, EQ-5D-L)) and a questionnaire related to bowel symptoms (LARS). However, patients undergoing ostomy repair are excluded from the preoperati
standardOther
Subjects classified as control group will receive educational materials. One month and three months after surgery, a questionnaire related to bowel symptoms (LARS) will be administered by phone. The researcher will call the subjects and administer it according to the period. The results of the questionnaire related to bowel symptoms (LARS) administered by phone will be confirmed by the medical staff during outpatient treatment.
| Study group | Role | What they receive |
|---|---|---|
| comparator | Active comparator | Subjects classified as control group will receive educational materials. Receives: Other: standard |
| mobile app | Experimental | Subjects in the experimental group and pilot phase will install the management program app on their mobile phones and use it directly for 6 months. Receives: Other: Mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of low anterior resection syndrome
The incidence of high-risk low anterior resection syndrome with a score of 30 to 42 in the bowel symptom questionnaire
Measured: 1 year after surgery
Secondary outcomes (1)
Symptom change
daily bowel frequency
Measured: At patient registration and at 1, 3, 6, 12, 24, 36, and 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dae Kyung Sohn, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041515
- Sponsor's protocol ID
- NCC2025-0022
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryoo SB, Ahn HM, Nam BH, Song YM, Sohn DK. K-LARS trial: protocol for a multicentre randomised controlled trial evaluating a knowledge-enhanced digital intervention to prevent low anterior resection syndrome in Korea. BMJ Open. 2025 Nov 29;15(11):e107819. doi: 10.1136/bmjopen-2025-107819.
PubMed 41320216
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Clinical Trial to Evaluate the Feasibility and Utility of a Postoperative Management App for Patients Undergoing Rectal Resection
- ClinicalTrials.gov ID
- NCT07041515
- Acronym / sponsor ID
- NCC2025-0022
- Conditions
- Rectal Neoplasm
- Keywords
- rectal neoplasm, low anterior resection syndrome, Patient Reported Outcome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2032 (estimated)
- First posted
- 27 Jun 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.
Low anterior resection syndrome refers to changes in bowel habits such as frequent defecation, urgent defecation, and fecal incontinence, which result in decreased bowel function. It occurs very commonly after surgery for colorectal cancer, especially rectal cancer, and symptoms appear severely immediately after surgery, followed by a recovery process. It is known that symptoms improve significantly after one year of surgery, but in some patients, symptoms persist, which significantly affects the quality of life and causes social problems.
There is no established treatment method for low anterior resection syndrome, and accurate evaluation and customized treatment are required according to the patient's surgical or radiotherapy treatment content and symptoms. It is also important to monitor the change in symptoms during the treatment process, and a customized step-by-step treatment strategy for such patients is required. However, such a customized step-by-step treatment strategy for such patients is very complex, and there are no clear guidelines to date, and the research design for some clinical trials has been recently reported.
The purpose of this study was to develop an app-based Patient-Reported Outcome (PRO) standardized questionnaire for patients after rectal cancer surgery to systematically collect and monitor symptom information, establish a multidisciplinary management plan tailored to patients, and provide education and treatment to improve the quality of life of rectal cancer survivors. A management program utilizing a research device (app) can reduce the incidence of Major LARS after rectal cancer surgery compared to standard treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparator | Active comparator | Other: standardSubjects classified as control group will receive educational materials. |
| mobile app | Experimental | Other: Mobile appSubjects in the experimental group and pilot phase will install the management program app on their mobile phones and use it directly for 6 months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 20-70 years
- Patients scheduled for anal-sparing rectal resection or stomy repair diagnosed with rectal cancer (within 15 cm from Anal Verge)
- Patients with an expected survival period of 1 year or more
- Patients or their primary caregivers use smartphones (apps)
- Patients who are aware of their own status and can provide consent for this study
Key exclusion criteria (5 listed)
- If you are receiving chemotherapy or radiotherapy at the time of consent
- If you are scheduled for major colectomy such as total colectomy or partial colectomy in addition to rectal resection
- If you cannot be contacted by phone
- If you cannot read and understand Korean
- If you cannot provide consent based on clear and sufficient information
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 |
|---|---|---|
| Mobile appThis study will be conducted in two stages, recruiting patients scheduled for low anterior resection and those scheduled for ostomy restoration after low anterior resection. The pilot stage study will recruit 20 subjects without randomization to evaluate the feasibility of the management program app, and the second stage study will be a parallel experimental-control study, recruiting approximately 300 research participants, 150 from each group. Patients scheduled for ostomy repair after low anterior resection and low anterior resection are required to fill out a consent form the day before, and participants are randomly assigned to one of two groups in a 1:1 ratio: the experimental group and the control group. Both groups are randomly assigned to four surveys. The types are three quality of life assessment questionnaires (QOL (EORTC QLQ-C30, CR-29, EQ-5D-L)) and a questionnaire related to bowel symptoms (LARS). However, patients undergoing ostomy repair are excluded from the preoperati | Other | mobile app |
| standardSubjects classified as control group will receive educational materials. One month and three months after surgery, a questionnaire related to bowel symptoms (LARS) will be administered by phone. The researcher will call the subjects and administer it according to the period. The results of the questionnaire related to bowel symptoms (LARS) administered by phone will be confirmed by the medical staff during outpatient treatment. | Other | comparator |
Primary outcome
Incidence of low anterior resection syndrome
Time frame: 1 year after surgery
The incidence of high-risk low anterior resection syndrome with a score of 30 to 42 in the bowel symptom questionnaire
1 secondary outcome
Symptom change
Time frame: At patient registration and at 1, 3, 6, 12, 24, 36, and 60 months after surgery
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 27 Jun 2025.
- Derived from this study: PubMed 41320216Ryoo SB, Ahn HM, Nam BH, Song YM, Sohn DK. K-LARS trial: protocol for a multicentre randomised controlled trial evaluating a knowledge-enhanced digital intervention to prevent low anterior resection syndrome in Korea. BMJ Open. 2025 Nov 29;15(11):e107819. doi: 10.1136/bmjopen-2025-107819.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app and standard in people with Rectal Neoplasm, run by National Cancer Center, 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 5 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of low anterior resection syndrome (time frame: 1 year after surgery). 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 NCT07041515, which also lists 1 linked publication.
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 27 Jun 2025.