LARS - Low Anterior Resection SyndromeNCT07082699
The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal
A study testing antegrade enema and retrograde enema in people with LARS - Low Anterior Resection Syndrome, run by Sichuan Cancer Hospital and Research Institute.
Trial summary
Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation dysfunction after surgery, such as frequent bowel movements, urgent bowel movements, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- LARS - Low Anterior Resection Syndrome
- What is being tested?
- antegrade enema and retrograde enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2025to 30 Dec 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the NCCN guidelines for the pathological diagnosis of rectal cancer, the patient has primary rectal adenocarcinoma;
- Age ≥ 18 years;
- Previously underwent rectal resection with prophylactic ileostomy via laparoscopy, robotics, or open surgery;
- Expected to undergo ileostomy reversal surgery within 1-2 months;
- Possesses normal cognitive and communication abilities;
- Voluntarily participates in this study and has signed an informed consent form.
Who cannot join
- American Society of Anesthesiologists (ASA) classification III or higher;
- Concurrent inflammatory bowel disease, Crohn's disease, or other intestinal diseases;
- Mental disorders, long-term use of psychiatric drugs;
- Contraindications to enemas.
About this study
Official title: The Efficacy of Antegrade and Retrograde Enemas in the Management of Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal: A Single-Centre, Prospective Randomised Controlled Trial
Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation dysfunction after surgery, such as frequent bowel movements, urgent bowel movements, and faecal incontinence, known as low anterior resection syndrome (LARS). This can lead to a decline in quality of life after surgery and even partial loss of social functioning.
- Conditions
- LARS - Low Anterior Resection Syndrome
- Being tested
- antegrade enema, retrograde enema
- Medical subject headings
- Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antegrade enemaOther
Introduce saline at a flow rate of 40 ml/minute through the distal end of the ileostomy. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.
retrograde enemaOther
Introduce saline at a flow rate of 40 ml/minute through the anus. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Not described |
| antegrade enema | Experimental | Not described Receives: Other: antegrade enema |
| retrograde enema | Experimental | Not described Receives: Other: retrograde enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of ileostomy reversal
Measured: Two months after the last enema
low anterior resection syndrome score (LARS score)
The LARS score consists of five components and the total score, ranging from 0 to 42. Severity levels are categorized as follows: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points).
Measured: Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.
Secondary outcomes (3)
quality of sleep
Quality of sleep was evaluated by Pittsburgh Quality Index (PSQI). The PSQI assesses a participant's sleep quality in the previous month using 18 items divided into 7 components. Each component is graded between 0 and 3. The total score is 0-21, with higher scores indicating poorer sleep quality.
Measured: Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.
bowel function
The Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (MSKCC BFI) is used to assess bowel function. This questionnaire comprises three dimensions, totaling 18 items. The total scale score ranged from 18 to 90, with higher scores indicating better bowel function.
Measured: one month, two months, three months, and six months after stoma closure.
cancer patients' quality of life
The quality of life was assessd by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29). The scale includes 4 functional domains, 19 symptom domains, and 6 stoma-related items. Each item, except for item 18 (which indicates the presence or absence of a stoma), is rated on a 4-point scale: 'not at all,' 'a little,' 'quite a bit,' and 'very much,' corresponding to scores of 1 to 4, respectively. Scores are converted into standardized values ranging from 0 to 100 using polarization. Higher scores in the functional domains indicate better function, whereas higher scores in the symptom domains reflect more severe symptoms.
Measured: one month, two months, three months, and six months after stoma closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LARS - 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Yang, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082699
- Sponsor's protocol ID
- IIT2024153
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Antegrade and Retrograde Enemas in the Management of Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal: A Single-Centre, Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07082699
- Acronym / sponsor ID
- IIT2024153
- Conditions
- LARS - Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jul 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.
Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation dysfunction after surgery, such as frequent bowel movements, urgent bowel movements, and faecal incontinence, known as low anterior resection syndrome (LARS). This can lead to a decline in quality of life after surgery and even partial loss of social functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | – |
| antegrade enema | Experimental | Other: antegrade enema |
| retrograde enema | Experimental | Other: retrograde enema |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- According to the NCCN guidelines for the pathological diagnosis of rectal cancer, the patient has primary rectal adenocarcinoma;
- Age ≥ 18 years;
- Previously underwent rectal resection with prophylactic ileostomy via laparoscopy, robotics, or open surgery;
- Expected to undergo ileostomy reversal surgery within 1-2 months;
- Possesses normal cognitive and communication abilities;
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) classification III or higher;
- Concurrent inflammatory bowel disease, Crohn's disease, or other intestinal diseases;
- Mental disorders, long-term use of psychiatric drugs;
- Contraindications to enemas.
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 |
|---|---|---|
| antegrade enemaIntroduce saline at a flow rate of 40 ml/minute through the distal end of the ileostomy. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month. | Other | antegrade enema |
| retrograde enemaIntroduce saline at a flow rate of 40 ml/minute through the anus. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month. | Other | retrograde enema |
Primary outcome
Success rate of ileostomy reversal
Time frame: Two months after the last enema
low anterior resection syndrome score (LARS score)
Time frame: Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.
The LARS score consists of five components and the total score, ranging from 0 to 42. Severity levels are categorized as follows: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points).
3 secondary outcomes
quality of sleep
Time frame: Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.
bowel function
Time frame: one month, two months, three months, and six months after stoma closure.
cancer patients' quality of life
Time frame: one month, two months, three months, and six months after stoma closure.
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 24 Jul 2025.
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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 antegrade enema and retrograde enema in people with LARS - Low Anterior Resection Syndrome, run by Sichuan Cancer Hospital and Research Institute.
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 4 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 24 Jul 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?
Success rate of ileostomy reversal (time frame: Two months after the last enema). 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?
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 24 Jul 2025.