Low Anterior Resection SyndromeNCT06717854
Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial
A study testing transanal irrigation and antegrade enema in people with Low Anterior Resection Syndrome, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are: 1. To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- transanal irrigation and antegrade enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 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
- Based on the NCCN guidelines for the pathological diagnosis of rectal cancer, patients are identified as having Primary Rectal Adenocarcinoma.
- ≥18 years.
- For the first time, anterior rectal dissection combined with prophylactic ileostomy was performed using laparoscopic, robotic, and open techniques.
- The patient exhibits normal cognitive and expressive abilities.
- Informed consent was obtained for voluntary participation in the study.
Who cannot join
- American Society of Anesthesiologists (ASA) Class III or higher.
- A combination of other intestinal conditions, including inflammatory bowel disease and Crohn's disease.
- Mental disorders and prolonged use of psychotropic medications.
- The presence of contraindications to enema administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Afffliated Cancer Hospital of University of Electronic Science and Technology of China
Chengdu, Sichuan
Hai Hu, M.D., 8613540662185, Hu_hai2019@outlook.com
About this study
Official title: Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial
The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are:
- To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery
- To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection.
Read more
Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS.
Participants will:
- Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal.
- Keep a diary of their symptoms.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- transanal irrigation, antegrade 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.
transanal irrigationOther
The enema is administered retrogradely via the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. the catheter is gently and slowly inserted 7-10 cm through the anus. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.
antegrade enemaOther
The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. Using a disposable catheter, insert it about 20 cm. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | The standard of care (SOC) was implemented following low anterior resection, which included the distribution of pamphlets and instructional videos to patients and their caregivers. |
| antegrade enema | Experimental | Participants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. |
| retrograde enema | Experimental | Participants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered retrogradely via the anus. Receives: Other: transanal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
low anterior resection syndrome score (LARS score)
Measured: Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal
Secondary outcomes (3)
bowel function
Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI)
Measured: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
quality of life for rectal cancer patients
quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 )
Measured: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
quality of sleep
Pittsburgh Quality Index (PSQI)
Measured: before anterior rectal resection, before starting enemas 1 month postoperatively, 2 months, 3-4 months postoperatively; 1 month, 2 months, 3 months, 6 months after stoma reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start25 Mar 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 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
- Prevention
- 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
- NCT06717854
- Sponsor's protocol ID
- SCCHEC-02-2024-226
- Status last verified
- Nov 2024
- First submitted
- 30 Nov 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06717854
- Acronym / sponsor ID
- SCCHEC-02-2024-226
- Conditions
- 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
- 25 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (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 goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are:
- To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery
- To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection.
Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS.
Participants will:
- Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal.
- Keep a diary of their symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | –The standard of care (SOC) was implemented following low anterior resection, which included the distribution of pamphlets and instructional videos to patients and their caregivers. |
| antegrade enema | Experimental | –Participants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. |
| retrograde enema | Experimental | Other: transanal irrigationParticipants assigned to this group received the standardized of care as the basis for the intervention. The enema is administered retrogradely via the anus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Based on the NCCN guidelines for the pathological diagnosis of rectal cancer, patients are identified as having Primary Rectal Adenocarcinoma.
- ≥18 years.
- For the first time, anterior rectal dissection combined with prophylactic ileostomy was performed using laparoscopic, robotic, and open techniques.
- The patient exhibits normal cognitive and expressive abilities.
- Informed consent was obtained for voluntary participation in the study.
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) Class III or higher.
- A combination of other intestinal conditions, including inflammatory bowel disease and Crohn's disease.
- Mental disorders and prolonged use of psychotropic medications.
- The presence of contraindications to enema administration.
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 enema is administered retrogradely via the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. the catheter is gently and slowly inserted 7-10 cm through the anus. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes. | Other | retrograde enema |
| antegrade enemaThe enema is administered through the distal end of the ileocecal stoma, directed towards the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. Using a disposable catheter, insert it about 20 cm. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes. | Other | – |
Primary outcome
low anterior resection syndrome score (LARS score)
Time frame: Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal
3 secondary outcomes
bowel function
Time frame: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
quality of life for rectal cancer patients
Time frame: before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
quality of sleep
Time frame: before anterior rectal resection, before starting enemas 1 month postoperatively, 2 months, 3-4 months postoperatively; 1 month, 2 months, 3 months, 6 months after stoma reduction
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 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 and antegrade enema in people with Low Anterior Resection Syndrome, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
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 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 30 Mar 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 China. 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 Hai Hu, M.D. (8613540662185, Hu_hai2019@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
low anterior resection syndrome score (LARS score) (time frame: Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal). 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 30 Mar 2025.