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

NCT ID: NCT05461248

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-05-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

stoma drainage reinfusion

Intervention Type: 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.

Conventional group

The conventional group received no additional intervention.

Group Type: SHAM_COMPARATOR

Standard of Care - No Return of Stoma Drain

Intervention Type: PROCEDURE

No Return of Stoma Drain

Interventions

stoma drainage reinfusion

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.

Intervention Type: PROCEDURE

Standard of Care - No Return of Stoma Drain

No Return of Stoma Drain

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Quan Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quan Wang, Prof.

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

Jilin University First Hospital

Changchun, Jilin, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STARS-RC04

Identifier Type: -

Identifier Source: org_study_id