Clinical trial · Interventional
Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care - No Return of Stoma Drain | Procedure | — | UNRESOLVED |
| stoma drainage reinfusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 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.
- interventionNames
- Procedure: stoma drainage reinfusion
- type
- SHAM_COMPARATOR
- label
- Conventional group
- description
- The conventional group received no additional intervention.
- interventionNames
- Procedure: Standard of Care - No Return of Stoma Drain
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria 1. Age: 18\~75 years old, male or female; 2. Pathological diagnosis of adenocarcinoma of the rectum on preoperative biopsy; 3. Clinical staging was T1-4aN0-2M0; 4. No distant multiple metastases; 5. ECOG rating 0-2; 6. Cardiac, pulmonary, hepatic and renal functions met the criteria for surgical tolerance 7. 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; 8. Patients and their families were able to understand and willing to participate in this clinical study and signed an informed consent form. Exclusion criteria 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 1. Accompanied by other non-oncological conditions that make it impossible for the patient to continue to receive this treatment plan; 2. After enrolment in the study, patients who required emergency surgery due to intestinal obstruction, perforation, or bleeding,et al. prior to stoma closure; 3. Patients with pathologically confirmed distant metastases after rectal surgery, including liver, pelvis, ovary, peritoneum, and distant lymph node metastases; 4. Intraoperative exploration for middle and low rectal cancer in anus-preserving surgery for those who need combined organ resection; 5. 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; 6. Anastomotic fistula, severe anastomotic stenosis (inability to pass through enteroscopy or oesophageal finger and inability to dilate via oesophageal finger) after radical rectal surgery.
References
Publications (1)
- DERIVEDZhang 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. PMID 41233674