Rectal CancerNCT05461248
Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
A study testing stoma drainage reinfusion in people with Rectal Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
To analyze the occurrence of defecation complications, rectal function, and quality of life indicators after sphincter-preserving surgery for middle and low rectal cancer, the stoma exudate was collected before the stoma was restored, and the defecation complications, rectal function and quality of life indicators… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- stoma drainage reinfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18~75 years old, male or female;
- Pathological diagnosis of adenocarcinoma of the rectum on preoperative biopsy;
- Clinical staging was T1-4aN0-2M0;
- No distant multiple metastases;
- ECOG rating 0-2;
- Cardiac, pulmonary, hepatic and renal functions met the criteria for surgical tolerance
- Clinical diagnosis of middle and low rectal cancer, the lower edge of the tumour is within 10cm from the anal verge, and it is proposed to perform radical rectal surgery and prophylactic ileostomy at stage I, and intestinal closure at stage II;
- Patients and their families were able to understand and willing to participate in this clinical study and signed an informed consent form.
Who cannot join
- 1. Previous history of malignant colorectal tumour or recently diagnosed combination of other malignant tumours; 2、Patients with combined intestinal obstruction, intestinal perforation, intestinal haemorrhage, etc. requiring emergency surgery; 3. Neighbouring organs requiring combined organ removal; 4. ASA classification ≥ Grade IV and/or ECOG physical status score > 2; 5. Those who have serious liver and kidney dysfunction, cardiopulmonary dysfunction, coagulation dysfunction or combined serious basic diseases cannot tolerate the surgery; 6. Have a history of serious mental illness; 7. Pregnant or breastfeeding women; 8. Those who have a history of taking steroid drugs; 9. Patients with other clinical and laboratory conditions considered by the investigator to be inappropriate for participation in the trial; 10. One week before the operation, there are signs of infection, body temperature rises >37.5°C, blood WBC >10.0×109/L; 11. History of antibiotic use 1 week prior to surgery (excluding preoperative shock medication); 12. Preoperative neoadjuvant patients
- Exit criteria
- Accompanied by other non-oncological conditions that make it impossible for the patient to continue to receive this treatment plan;
- After enrolment in the study, patients who required emergency surgery due to intestinal obstruction, perforation, or bleeding,et al. prior to stoma closure;
- Patients with pathologically confirmed distant metastases after rectal surgery, including liver, pelvis, ovary, peritoneum, and distant lymph node metastases;
- Intraoperative exploration for middle and low rectal cancer in anus-preserving surgery for those who need combined organ resection;
- After enrolment in the study, patients requested to withdraw from the study cohort for various reasons, or were unable to complete the study programme and follow-up for various reasons;
- Anastomotic fistula, severe anastomotic stenosis (inability to pass through enteroscopy or oesophageal finger and inability to dilate via oesophageal finger) after radical rectal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study on the Recovery of Intestinal Flora and Intestinal Function by Preventing Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
To analyze the occurrence of defecation complications, rectal function, and quality of life indicators after sphincter-preserving surgery for middle and low rectal cancer, the stoma exudate was collected before the stoma was restored, and the defecation complications, rectal function and quality of life indicators were evaluated. The effect of anal reinfusion of stoma discharge on the recovery of intestinal function in patients.
Read the detailed description
Previous studies have shown that the mucosa and villi of the left intestinal segment will atrophy after intestinal bypass, the absorption capacity will decrease, and the rhythmic contraction will disappear. Some studies have shown that irrigation through the anorectal cavity may help prevent and treat colorectal anastomotic fistulas and improve the postoperative life of patients. Based on this, it is hypothesized that the stimulation of stomal exudate anal reinfusion to the empty intestinal segment through the anus may help to promote the recovery of intestinal function and intestinal flora disturbance after stoma retraction.
In response to this hypothesis, in this study, we intend to carry out a prospective and observational study on patients with stoma resection, aiming to investigate whether the stimulation of stoma discharge and anal reinfusion of stoma drainage through the anus before resection has any effect on the anus. It is beneficial to the recovery of intestinal function, reducing the occurrence of complications and improving the imbalance of intestinal flora, providing high-level clinical evidence.
- Conditions
- Rectal Cancer
- Being tested
- stoma drainage reinfusion, Standard of Care - No Return of Stoma Drain
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stoma drainage reinfusionProcedure or surgery
1 month after radical rectal surgery, the stoma drainage fluid was reinfused once a week for 2 months. For each reinfusion, eat liquid food the day before, collect 400-600mL of stoma discharge on the same day (if the stoma fluid is too small, it can be mixed with warm water), and use an enema bag to reinfuse from the patient's anus. Generally, the flow rate is controlled at about 100mL/min.
Standard of Care - No Return of Stoma DrainProcedure or surgery
No Return of Stoma Drain
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The stoma drainage fluid was reinfused once a week for 2 months after radical rectal surgery. For each reinfusion, eat liquid food the day before, collect 400-600mL of stoma discharge on the same day (if the stoma fluid is too small, it can be mixed with warm water), and use an enema bag to reinfuse from the patient's anus. Generally, the flow rate is controlled at about 100mL/min. Receives: Procedure: stoma drainage reinfusion |
| Conventional group | Sham comparator | The conventional group received no additional intervention. Receives: Procedure: Standard of Care - No Return of Stoma Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of low anterior resection syndrome
Incidence of low anterior resection syndrome six months after stoma closure surgery
Measured: six months after stoma closure surgery
Secondary outcomes (7)
Bacteriological sequencing after stoma closure surgery
Bacteriological sequencing 1 month after stoma closure surgery
Measured: 1 month after stoma reversal
Low Anterior Resection Syndrome (LARS) questionnaire
Low Anterior Resection Syndrome, is a clinical condition that occurs in patients who have undergone anterior resection of the rectum, resulting in bowel dysfunction and experience at least one of the symptoms associated with LARS, leading to at least one negative consequence. The LARS scale classifies patients into three severity categories: no LARS (0-20), mild LARS (21-29), and major LARS (30-42). Higher scores mean a worse outcome.
Measured: 1 month after stoma reversal
Wexner incontinence score
The Wexner Incontinence Score, also known as the Wexner Constipation Grading Scale, is a quantitative tool used to assess the severity of anal incontinence. This scoring system calculates scores by patients completing a daily defecation questionnaire to assess their anal control function. The Wexner incontinence score typically covers the following aspects: gas incontinence, liquid fecal incontinence, solid fecal incontinence, use of liners, lifestyle changes. Each evaluation item has a corresponding score range, usually from 0 to 4 points, where 0 points means it never happened and 4 points means it always happened. Add up the scores of all projects to obtain the total score. The total score ranges from 0 to 20, with 0 indicating completely normal and 20 indicating the most severe incontinence.
Measured: 1 month after stoma reversal
MSKCC Bowl Function Questionnaire
The MSKCC Bowl Function Questionnaire is a tool used to evaluate the intestinal function of patients with rectal cancer after undergoing surgery, radiation therapy, chemotherapy, and other treatments. This questionnaire typically contains multiple items, each asking questions about different aspects of the patient's intestinal function. Except for the first item, all other items are rated on a Likert 5-point scale, namely "always", "often", "sometimes", "rarely", and "never", with scores of 1, 2, 3, 4, and 5, respectively. In the questionnaire, certain items are set as reverse scoring, meaning that the higher the score, the worse the function. The total score of the scale is obtained by adding the scores of all items. The higher the total score, the better the patient's intestinal function. Due to the inclusion of reverse scoring items in the questionnaire, special treatment is required for these items when calculating the total score to ensure its accuracy and reliability.
Measured: 1 month after stoma reversal
Glazer pelvic floor muscle surface electromyography
Glazer pelvic floor muscle surface electromyography is a detection method used to evaluate the function of pelvic floor muscles. This method collects electromyographic signals of pelvic floor muscles through surface electrodes, and then evaluates the functional status of pelvic floor muscles. By analyzing the amplitude, frequency, variability, and other parameters of these electrical signals, the supportive function, sexual function, and sphincter function of pelvic floor muscles can be evaluated. The evaluation process typically includes five stages: pre resting stage, phase contraction stage, tonic contraction stage, endurance contraction stage, and post resting stage. The higher the score, the better the pelvic floor muscle function. At the same time, it is necessary to assess the performance of pelvic floor muscles in different functional aspects based on individual scores.
Measured: 1 month after stoma reversal
Quality of life (QOL) score
QOL score is often used to assess the quality of life and health status of a cancer patient, and based on these health status scores, determine the treatment options that the patient can accept. The evaluation indicators mainly include 12 aspects, including appetite, mental state, sleep, fatigue, pain, family understanding and cooperation, colleagues' understanding and cooperation, personal understanding of cancer, attitude towards treatment, daily life, side effects of treatment, and facial expressions. 60 points is the maximum score, if it is less than 20 points, it belongs to extremely poor quality of life; 21-30 points belong to poor quality of life; a score of 31-40 indicates an average quality of life; a score of 41-50 indicates a relatively good quality of life; a score of 51-60 indicates a good quality of life.
Measured: 1 month after stoma reversal
Recovery of postoperative bowel function
After reversal surgery, time to oral feeding, time to anal defecation after reduction surgery, and rate of intestinal obstruction (intestinal obstruction was defined as ,inability to tolerate food for more than 72 H or the need for re-fasting or gastrointestinal decompression) were observed.
Measured: 1 month after stoma reversal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Aug 2022
- Primary completion30 May 2024
- Study completion30 May 2024
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 CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group collected stoma exudates and used an enema bag to infuse them from the anus. The control group was not reinfused.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
- Investigators
- Quan Wang, Prof., Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461248
- Sponsor's protocol ID
- STARS-RC04
- Status last verified
- Nov 2024
- First submitted
- 14 Jul 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang S, He L, Zhang L, Sun J, Wang Y, Wang M, Zhao Y, Sun X, Gong Y, Li Z, Guo Y, Wang Q. Effects of stoma discharge reinfusion on low anterior resection syndrome and the gut microbiota following sphincter-preserving surgery for middle and low rectal cancer: a randomized clinical trial. Updates Surg. 2026 Apr;78(2):619-635. doi: 10.1007/s13304-025-02454-0. Epub 2025 Nov 13.
PubMed 41233674
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Recovery of Intestinal Flora and Intestinal Function by Preventing Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT05461248
- Acronym / sponsor ID
- STARS-RC04
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 18 Jul 2022 (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.
To analyze the occurrence of defecation complications, rectal function, and quality of life indicators after sphincter-preserving surgery for middle and low rectal cancer, the stoma exudate was collected before the stoma was restored, and the defecation complications, rectal function and quality of life indicators were evaluated. The effect of anal reinfusion of stoma discharge on the recovery of intestinal function in patients.
Detailed description
Previous studies have shown that the mucosa and villi of the left intestinal segment will atrophy after intestinal bypass, the absorption capacity will decrease, and the rhythmic contraction will disappear. Some studies have shown that irrigation through the anorectal cavity may help prevent and treat colorectal anastomotic fistulas and improve the postoperative life of patients. Based on this, it is hypothesized that the stimulation of stomal exudate anal reinfusion to the empty intestinal segment through the anus may help to promote the recovery of intestinal function and intestinal flora disturbance after stoma retraction.
In response to this hypothesis, in this study, we intend to carry out a prospective and observational study on patients with stoma resection, aiming to investigate whether the stimulation of stoma discharge and anal reinfusion of stoma drainage through the anus before resection has any effect on the anus. It is beneficial to the recovery of intestinal function, reducing the occurrence of complications and improving the imbalance of intestinal flora, providing high-level clinical evidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group collected stoma exudates and used an enema bag to infuse them from the anus. The control group was not reinfused.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: stoma drainage reinfusionThe stoma drainage fluid was reinfused once a week for 2 months after radical rectal surgery. For each reinfusion, eat liquid food the day before, collect 400-600mL of stoma discharge on the same day (if the stoma fluid is too small, it can be mixed with warm water), and use an enema bag to reinfuse from the patient's anus. Generally, the flow rate is controlled at about 100mL/min. |
| Conventional group | Sham comparator | Procedure: Standard of Care - No Return of Stoma DrainThe conventional group received no additional intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18~75 years old, male or female;
- Pathological diagnosis of adenocarcinoma of the rectum on preoperative biopsy;
- Clinical staging was T1-4aN0-2M0;
- No distant multiple metastases;
- ECOG rating 0-2;
Key exclusion criteria (8 listed)
- 1. Previous history of malignant colorectal tumour or recently diagnosed combination of other malignant tumours; 2、Patients with combined intestinal obstruction, intestinal perforation, intestinal haemorrhage, etc. requiring emergency surgery; 3. Neighbouring organs requiring combined organ removal; 4. ASA classification ≥ Grade IV and/or ECOG physical status score > 2; 5. Those who have serious liver and kidney dysfunction, cardiopulmonary dysfunction, coagulation dysfunction or combined serious basic diseases cannot tolerate the surgery; 6. Have a history of serious mental illness; 7. Pregnant or breastfeeding women; 8. Those who have a history of taking steroid drugs; 9. Patients with other clinical and laboratory conditions considered by the investigator to be inappropriate for participation in the trial; 10. One week before the operation, there are signs of infection, body temperature rises >37.5°C, blood WBC >10.0×109/L; 11. History of antibiotic use 1 week prior to surgery (excluding preoperative shock medication); 12. Preoperative neoadjuvant patients
- Exit criteria
- Accompanied by other non-oncological conditions that make it impossible for the patient to continue to receive this treatment plan;
- After enrolment in the study, patients who required emergency surgery due to intestinal obstruction, perforation, or bleeding,et al. prior to stoma closure;
- Patients with pathologically confirmed distant metastases after rectal surgery, including liver, pelvis, ovary, peritoneum, and distant lymph node metastases;
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 |
|---|---|---|
| stoma drainage reinfusion1 month after radical rectal surgery, the stoma drainage fluid was reinfused once a week for 2 months. For each reinfusion, eat liquid food the day before, collect 400-600mL of stoma discharge on the same day (if the stoma fluid is too small, it can be mixed with warm water), and use an enema bag to reinfuse from the patient's anus. Generally, the flow rate is controlled at about 100mL/min. | Procedure or surgery | Experimental group |
| Standard of Care - No Return of Stoma DrainNo Return of Stoma Drain | Procedure or surgery | Conventional group |
Primary outcome
Incidence of low anterior resection syndrome
Time frame: six months after stoma closure surgery
Incidence of low anterior resection syndrome six months after stoma closure surgery
7 secondary outcomes
Bacteriological sequencing after stoma closure surgery
Time frame: 1 month after stoma reversal
Low Anterior Resection Syndrome (LARS) questionnaire
Time frame: 1 month after stoma reversal
Wexner incontinence score
Time frame: 1 month after stoma reversal
MSKCC Bowl Function Questionnaire
Time frame: 1 month after stoma reversal
Glazer pelvic floor muscle surface electromyography
Time frame: 1 month after stoma reversal
Quality of life (QOL) score
Time frame: 1 month after stoma reversal
Recovery of postoperative bowel function
Time frame: 1 month after stoma reversal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 41233674Zhang S, He L, Zhang L, Sun J, Wang Y, Wang M, Zhao Y, Sun X, Gong Y, Li Z, Guo Y, Wang Q. Effects of stoma discharge reinfusion on low anterior resection syndrome and the gut microbiota following sphincter-preserving surgery for middle and low rectal cancer: a randomized clinical trial. Updates Surg. 2026 Apr;78(2):619-635. doi: 10.1007/s13304-025-02454-0. Epub 2025 Nov 13.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Quan Wang, Prof. principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stoma drainage reinfusion in people with Rectal Cancer, run by The First Hospital of Jilin 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 22 Nov 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: six months after stoma closure 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 NCT05461248, 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 22 Nov 2024.