About this trial
This study aims to propose a novel, easy-to-operate intervention strategy that effectively improves defecation function after stoma reversal and to assess its impact on the gut microbiota.The efficacy and safety of antegrade placement of probiotics into the distal deserted intestine during prophylactic stoma to improve bowel function after stoma reversal were evaluated through randomized controlled clinical trials.Observing the changes in gut microbiota during the prophylactic stoma period, the impact of probiotics on the structure of gut microbiota, and exploring the correlation between gut genera and bowel function after stoma reversal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years
Ultra low rectal cancer meeting the indication for Intersphincteric Resection (ISR) surgery
Underwent a prophylactic ileostomy
Scheduled for stoma reversal surgery within 6 months after the ISR procedure
Disqualifiers
Does not meet the surgical indications for Intersphincteric Resection (ISR)
Presence of multiple primary colorectal malignancies
Patients who have received neoadjuvant radiotherapy
Patients who experience disease progression or death in the postoperative period
Trial design
Parallel
Treatments tested in this trial
Clostridium butyricum (live) Tablets(Meiya)
Biological/VaccineClostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention
Treatment groups
Trial outcomes
Primary outcomes
Low Anterior Resection Syndrome Score(LARS Score)
Comparison of LARS scores among the three groups at one month postoperatively. Low Anterior Resection Syndrome (LARS) is characterized by major symptoms including difficulty defecating, urgency, incontinence of liquid stool, incontinence of flatus, and increased frequency of bowel movements. Based on severity, LARS can be classified as none (0-20 points), minor (21-29 points), or major (30-42 points) using LARS score. And higher scores mean a worse outcome.
microbial diversity
Fecal samples from study participants with ISR preoperatively and postoperatively will be collected to analyze the alpha and beta diversity of gut microbiota among the three groups
Secondary outcomes
Wexner Incontinence Score
The Wexner Incontinence Score (WIS) assesses the severity of incontinence from five aspects: solid stool incontinence, liquid stool incontinence, flatus incontinence, pad usage, and lifestyle alterations. The score ranges from 0 to 20, where 0 represents normal and 20 represents complete incontinence.
Kirwan Incontinence Score
This grading system classifies anal incontinence into five grades (I-V) based on symptom severity: Grade I: No incontinence; Grade II: Incontinence to flatus or liquid stool; Grade III: Occasional solid stool incontinence; Grade IV: Frequent solid stool incontinence; Grade V: Requires a stoma (fecal diversion). Among these, Grades I-II indicate good continence function, while Grades III-IV indicate poor continence function.
Exploratory LARS Scoring Instrument
An exploratory scoring instrument was used to determine the severity of 16 specific variables that were identified by the Delphi consensus for defining LARS. In accordance with the response range defined by the WIS, there were 5 frequency options ranging from never (meaning no episodes; score 0) to always (meaning 1 or more episodes/day; score 4) for each item. Given that social and psychological features (marital separation, divorce, widowed seniors, etc) may have an influence on "relationships and intimacy," its response category for "never" was replaced with dichotomous options of "none" and "N/A." The summary score, also called the Delphi consensus severity score, was used as an index for patient-reported severity of LARS, ranging from 0 (best) to 64 (worst).
Fecal Incontinence Quality of Life (FIQL) Scale
The Fecal Incontinence Quality-of-Life (FIQL) Scale was used to analyze CSQoL. The FIQL entails 29 items that cover 4 domains: lifestyle (10 items), coping/behavior (9 items), depression/self-perception (7 items), and embarrassment (3 items).19 Each item has a range of 1 to 4 (except 2 items in depression/self-perception with ranges of 1-5 and 1-6). The score for each domain is the average of all items within its domain, and the global score is the mean of all domains. Higher scores indicate better CSQoL.
Sponsors and contacts
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Huashan Hospital
Lead sponsor
Characteristic Medical Center of Rocket Army
Collaborator
Zhongnan Hospital
Collaborator
The First Affiliated Hospital of Nankai University
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Ruijin Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator