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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05461248
• Other study ID #: STARS-RC04
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: July 2022
• Source: The First Hospital of Jilin University
• Contact: Quan Wang, Prof.
• Phone: 0431-81875602
• Email: wquan[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18~75 years old, male or female;

2. The pathological diagnosis of preoperative biopsy was rectal adenocarcinoma;

3. The clinical stage is T1-4aN0-2M0;

4. No distant multiple metastasis;

5. ECOG score 0-2;

6. Heart, lung, liver and kidney function can tolerate surgery;

7. The clinical diagnosis of middle-low rectal cancer, the lower edge of the tumor is within 10cm from the anal verge, the patients who are to undergo radical rectal resection and prophylactic ileostomy in stage I and intestinal closure in stage II;

8. Patients and their families can understand and be willing to participate in this clinical study, and sign the informed consent.

Exclusion Criteria:

1. Past history of malignant colorectal tumor or recent diagnosis with other malignant tumors;

2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery;

3. Adjacent organs need combined organ resection;

4. ASA grade = grade IV and/or ECOG performance status score > 2 points;

5. Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases who cannot tolerate surgery;

6. Have a history of serious mental illness;

7. Pregnant or lactating women;

8. Those who have a history of taking hormone drugs;

9. Patients with other clinical and laboratory conditions considered by the researchers should not participate in the trial;

10. There are signs of infection 1 week before the operation, the body temperature is higher than 37.5?, and the blood WBC is higher than 10.0×109/L;

11. There is a history of antibiotic use 1 week before surgery (excluding preoperative shock drugs);

12. Preoperative neoadjuvant patients.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• 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.
• Standard of Care - No Return of Stoma Drain
No Return of Stoma Drain

Locations

Country	Name	City	State
China	Jilin University First Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of low anterior resection syndrome	Incidence of low anterior resection syndrome one month after surgery	one month after surgery
Secondary	Incidence of low anterior resection syndrome	Incidence of low anterior resection syndrome 3 months after stoma reversal	3 months after stoma reversal
Secondary	Wexner score	The Wexner score includes 6 dimensions, including sanitary pads, solids, and liquids, with a total score of 20. The score is proportional to the patient's degree of anal incontinence.	3 months after stoma reversal
Secondary	Quality of life score	The EORTCQLQ-C30 scale is a cross-cultural and cross-country QOL-C30 (Quality of Life Questionnare-Core 30) launched by the European Organization for Research on Cancer Treatment (EORTC: The European O-rganization for Reasearch and Treatment of Cancer) in 1993. ), to evaluate QOL from a multi-dimensional perspective, which can better reflect the connotation of QOL, and has been applied to the measurement of QOL of cancer patients in many European countries and regions.	3 months after stoma reversal