Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer

NCT05461248 | Completed

• 1 other identifier: STARS-RC04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 were evaluated. The effect of anal reinfusion of stoma discharge on the recovery of intestinal function in patients.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of low anterior resection syndrome

  Incidence of low anterior resection syndrome six months after stoma closure surgery

  six months after stoma closure surgery

Secondary Outcomes (7)

• Bacteriological sequencing after stoma closure surgery

  1 month after stoma reversal

• Low Anterior Resection Syndrome (LARS) questionnaire

  1 month after stoma reversal

• Wexner incontinence score

  1 month after stoma reversal

• MSKCC Bowl Function Questionnaire

  1 month after stoma reversal

• Glazer pelvic floor muscle surface electromyography

  1 month after stoma reversal

Study Arms (2)

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.

Procedure: stoma drainage reinfusion

Conventional group

SHAM COMPARATOR

The conventional group received no additional intervention.

Procedure: Standard of Care - No Return of Stoma Drain

Interventions

stoma drainage reinfusion PROCEDURE

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.

Experimental group

Standard of Care - No Return of Stoma Drain PROCEDURE

No Return of Stoma Drain

Conventional group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

Jilin University First Hospital

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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. 2025 Nov 13. doi: 10.1007/s13304-025-02454-0. Online ahead of print.

  PMID: 41233674 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Quan Wang, Prof.

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: The experimental group collected stoma exudates and used an enema bag to infuse them from the anus. The control group was not reinfused.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: August 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)