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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: stoma drainage reinfusion; Procedure: Standard of Care - No Return of Stoma Drain

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jilin University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Sham Comparator: Conventional group; The conventional group received no additional intervention.	Procedure: Standard of Care - No Return of Stoma Drain; No Return of Stoma Drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteriological sequencing after stoma closure surgery	Bacteriological sequencing 1 month after stoma closure surgery	1 month after stoma reversal
Low Anterior Resection Syndrome (LARS) questionnaire	Low Anterior Resection Syndrome, is a clinical condition that occurs in patients who have undergone anterior resection of the rectum, resulting in bowel dysfunction and experience at least one of the symptoms associated with LARS, leading to at least one negative consequence. The LARS scale classifies patients into three severity categories: no LARS (0-20), mild LARS (21-29), and major LARS (30-42). Higher scores mean a worse outcome.	1 month after stoma reversal
Wexner incontinence score	The Wexner Incontinence Score, also known as the Wexner Constipation Grading Scale, is a quantitative tool used to assess the severity of anal incontinence. This scoring system calculates scores by patients completing a daily defecation questionnaire to assess their anal control function. The Wexner incontinence score typically covers the following aspects: gas incontinence, liquid fecal incontinence, solid fecal incontinence, use of liners, lifestyle changes. Each evaluation item has a corresponding score range, usually from 0 to 4 points, where 0 points means it never happened and 4 points means it always happened. Add up the scores of all projects to obtain the total score. The total score ranges from 0 to 20, with 0 indicating completely normal and 20 indicating the most severe incontinence.	1 month after stoma reversal
MSKCC Bowl Function Questionnaire	The MSKCC Bowl Function Questionnaire is a tool used to evaluate the intestinal function of patients with rectal cancer after undergoing surgery, radiation therapy, chemotherapy, and other treatments. This questionnaire typically contains multiple items, each asking questions about different aspects of the patient's intestinal function. Except for the first item, all other items are rated on a Likert 5-point scale, namely "always", "often", "sometimes", "rarely", and "never", with scores of 1, 2, 3, 4, and 5, respectively. In the questionnaire, certain items are set as reverse scoring, meaning that the higher the score, the worse the function. The total score of the scale is obtained by adding the scores of all items. The higher the total score, the better the patient's intestinal function. Due to the inclusion of reverse scoring items in the questionnaire, special treatment is required for these items when calculating the total score to ensure its accuracy and reliability.	1 month after stoma reversal
Glazer pelvic floor muscle surface electromyography	Glazer pelvic floor muscle surface electromyography is a detection method used to evaluate the function of pelvic floor muscles. This method collects electromyographic signals of pelvic floor muscles through surface electrodes, and then evaluates the functional status of pelvic floor muscles. By analyzing the amplitude, frequency, variability, and other parameters of these electrical signals, the supportive function, sexual function, and sphincter function of pelvic floor muscles can be evaluated. The evaluation process typically includes five stages: pre resting stage, phase contraction stage, tonic contraction stage, endurance contraction stage, and post resting stage. The higher the score, the better the pelvic floor muscle function. At the same time, it is necessary to assess the performance of pelvic floor muscles in different functional aspects based on individual scores.	1 month after stoma reversal
Quality of life (QOL) score	QOL score is often used to assess the quality of life and health status of a cancer patient, and based on these health status scores, determine the treatment options that the patient can accept. The evaluation indicators mainly include 12 aspects, including appetite, mental state, sleep, fatigue, pain, family understanding and cooperation, colleagues' understanding and cooperation, personal understanding of cancer, attitude towards treatment, daily life, side effects of treatment, and facial expressions. 60 points is the maximum score, if it is less than 20 points, it belongs to extremely poor quality of life; 21-30 points belong to poor quality of life; a score of 31-40 indicates an average quality of life; a score of 41-50 indicates a relatively good quality of life; a score of 51-60 indicates a good quality of life.	1 month after stoma reversal
Recovery of postoperative bowel function	After reversal surgery, time to oral feeding, time to anal defecation after reduction surgery, and rate of intestinal obstruction (intestinal obstruction was defined as ,inability to tolerate food for more than 72 H or the need for re-fasting or gastrointestinal decompression) were observed.	1 month after stoma reversal

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Quan Wang, Prof., The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: STARS-RC04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No