Low Anterior Resection SyndromeNCT06569966
The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure
A study testing preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon in people with Low Anterior Resection Syndrome, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to Dec 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-85 years old
- Karnofsky performance status (KPS)≥70%; Or ECOG score 2 points or less
- rectal cancer confirmed by preoperative pathology
- in the rectum resection before low, low colorectal anastomosis or after neoadjuvant therapy of patients
- prophylactic ileostomy.
Who cannot join
- cannot complete treatment
- the history of the anorectal surgery
- preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and functional constipation, etc.)
- postoperative anastomotic fistula and stricture
- during pregnancy or breastfeeding women
- with uncontrolled seizures, central nervous system disease or a history of mental disorders
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- the last five years have other history of malignant disease cured except skin cancer and cervical carcinoma in situ
- clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association class II or worse 9) severe congestive heart failure or major arrhythmia requiring medical intervention, or myocardial infarction within the previous 6 months
- has a history of cerebral infarction or cerebral hemorrhage within the past 6 months
- organ transplantation requiring immunosuppressive therapy
- serious uncontrolled repeated infections, or other serious with disease of control;
- moderate or severe renal impairment creatinine clearance equal to or less than 50ml/min, or upper limit of normal (ULN)
- emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)
- in screening the first 4 weeks received study medication or treatment (to participate in other test).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Affiliated Hospital of Qingdao
Qingdao, Shandong, 266000
Yanbing Zhou, +86 137 0897 1773, zhouyanbing@qduhospital.cn
Hao Chang, +86 178 5284 0122, 1013305163@qq.com
About this study
Official title: The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure: A Single Center Prospective Randomized Controlled Study
This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure.
Read the detailed description
The patients in the experimental group collected the contents of the ileostomyand placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded.Patients in the control group received routine perioperative management.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon
- 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.
preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colonBehavioural
The contents of the ileostomy were collected and placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Group | Experimental | The contents of the ileostomy were collected and placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded. Receives: Behavioral: preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon |
| Perioperative management group | No intervention | Perioperative management group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of low anterior resection syndrome
low anterior resection syndrome score（0-42，Higher scores indicate more severe symptoms）
Measured: 1 month after discharge, and 3, 6, and 12 months after surgery
Secondary outcomes (7)
the intestinal function recovery
The first postoperative exhaust and defecation time
Measured: up to 10 days after surgery
Concentration of C-reactive protein
Concentration of C-reactive protein after surgery
Measured: up to 10 days after surgery
Quality of Life Questionnaire Core 30
Quality of Life Questionnaire Core 30（0-100，standardscore，A higher score in the symptom domain indicates a worse quality of life）
Measured: 1 month after discharge, and 3, 6, and 12 months after surgery
fecal incontinence
The Cleveland clinic fecal incontinence score（0-20，Higher scores indicate more severe symptoms）
Measured: 1 month after discharge, and 3, 6, and 12 months after surgery
Weight change after rehabilitation
Weight change after rehabilitation
Measured: From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months
The number of emergency visits or rehospitalizations related to stoma closure
The number of emergency visits or rehospitalizations related to stoma closure
Measured: 1 year after surgery
the incidence of postoperative intestinal obstruction (POI)
the incidence of postoperative intestinal obstruction (POI)
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Jul 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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 The Affiliated Hospital of Qingdao UniversityThe 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
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanbing Zhou, Study chair, the Affiliated Hospital of Qingdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569966
- Sponsor's protocol ID
- Prehab-LARS2024
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure: A Single Center Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06569966
- Acronym / sponsor ID
- Prehab-LARS2024
- Conditions
- Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Aug 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.
This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure.
Detailed description
The patients in the experimental group collected the contents of the ileostomyand placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded.Patients in the control group received routine perioperative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Group | Experimental | Behavioral: preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colonThe contents of the ileostomy were collected and placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded. |
| Perioperative management group | No intervention | –Perioperative management group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18-85 years old
- Karnofsky performance status (KPS)≥70%; Or ECOG score 2 points or less
- rectal cancer confirmed by preoperative pathology
- in the rectum resection before low, low colorectal anastomosis or after neoadjuvant therapy of patients
- prophylactic ileostomy.
Key exclusion criteria (14 listed)
- cannot complete treatment
- the history of the anorectal surgery
- preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and functional constipation, etc.)
- postoperative anastomotic fistula and stricture
- during pregnancy or breastfeeding women
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 |
|---|---|---|
| preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colonThe contents of the ileostomy were collected and placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded | Behavioural | Prehabilitation Group |
Primary outcome
The extent of low anterior resection syndrome
Time frame: 1 month after discharge, and 3, 6, and 12 months after surgery
low anterior resection syndrome score（0-42，Higher scores indicate more severe symptoms）
7 secondary outcomes
the intestinal function recovery
Time frame: up to 10 days after surgery
Concentration of C-reactive protein
Time frame: up to 10 days after surgery
Quality of Life Questionnaire Core 30
Time frame: 1 month after discharge, and 3, 6, and 12 months after surgery
fecal incontinence
Time frame: 1 month after discharge, and 3, 6, and 12 months after surgery
Weight change after rehabilitation
Time frame: From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months
The number of emergency visits or rehospitalizations related to stoma closure
Time frame: 1 year after surgery
the incidence of postoperative intestinal obstruction (POI)
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
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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.
Yanbing Zhou study chair
the Affiliated Hospital of Qingdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon in people with Low Anterior Resection Syndrome, run by The Affiliated Hospital of Qingdao University 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 14 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 26 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanbing Zhou (+86 137 0897 1773, zhouyanbing@qduhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The extent of low anterior resection syndrome (time frame: 1 month after discharge, and 3, 6, and 12 months after surgery). 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 26 Aug 2024.