Clinical trial NCT05461248: Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of low anterior resection syndrome
timeFrame: six months after stoma closure surgery
Secondary outcomes:
measure: Bacteriological sequencing after stoma closure surgery
timeFrame: 1 month after stoma reversal
measure: Low Anterior Resection Syndrome (LARS) questionnaire
timeFrame: 1 month after stoma reversal
measure: Wexner incontinence score
timeFrame: 1 month after stoma reversal
measure: MSKCC Bowl Function Questionnaire
timeFrame: 1 month after stoma reversal
measure: Glazer pelvic floor muscle surface electromyography
timeFrame: 1 month after stoma reversal
measure: Quality of life (QOL) score
timeFrame: 1 month after stoma reversal
measure: Recovery of postoperative bowel function
timeFrame: 1 month after stoma reversal
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin University First Hospital
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: