Actively Recruiting
Effects of Ileostomy Contents Filtrate Reinfusion or Retention Enema on Bowel Function for LAR Patients With Ileostomy Before Stoma Closure: A Randomized Controlled Study
Led by The Affiliated Hospital of Qingdao University · Updated on 2024-08-26
154
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of two preoperative prehabilitation treatments on bowel function recovery in patients with low anterior resection syndrome (LAR) who have an ileostomy before stoma closure. The study evaluates whether reinfusion of ileostomy contents filtrate through the distal ileocolon or retention enema colon improves defecation function compared to traditional perioperative care. Conducted as a single-center randomized controlled trial, it focuses on patients preparing for stoma closure after rectal cancer surgery. Participants in the experimental group collect ileostomy contents, mix them with saline, and filter the mixture for use as an enema. This filtrate is slowly infused into the ileal output end of the ostomy via anterograde enema or transanal retention enema for 15-20 minutes, 2-3 times daily over 4 weeks. Meanwhile, the control group receives routine perioperative management without this intervention. Researchers observe adverse reactions like abdominal pain, distension, and fever during treatment and record daily prehabilitation details and patient weight. Throughout the study, patients are monitored for bowel function recovery, low anterior resection syndrome severity at 1 month and up to 12 months after surgery, quality of life, fecal incontinence, and weight changes. Additional outcomes include inflammatory markers, emergency visits or rehospitalizations related to stoma closure, and postoperative intestinal obstruction incidence. Assessments occur immediately after surgery and during follow-up visits over the course of a year, ensuring comprehensive evaluation of the prehabilitation impact on recovery and complications.
CONDITIONS
Brief Title
The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 85 years old
- Karnofsky performance status 70% or higher or ECOG score 2 or less
- Confirmed rectal cancer by preoperative pathology
- Undergoing low rectal resection with low colorectal anastomosis or after neoadjuvant therapy
- Having a prophylactic ileostomy
You will not qualify if you...
- Unable to complete treatment
- History of anorectal surgery
- Preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome, or functional constipation
- Postoperative anastomotic fistula or stricture
- Pregnant or breastfeeding women
- Uncontrolled seizures, central nervous system disease, or history of mental disorders
- Other malignant disease in the past five years except skin cancer and cervical carcinoma in situ
- Active heart disease including symptomatic coronary artery disease, severe heart failure, major arrhythmia, or recent myocardial infarction
- History of cerebral infarction or hemorrhage within the past 6 months
- Organ transplantation requiring immunosuppressive therapy
- Serious uncontrolled repeated infections or other serious uncontrolled diseases
- Moderate or severe renal impairment (creatinine clearance ≤ 50 ml/min or above upper normal limit)
- Emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)
- Received study medication or treatment within 4 weeks before screening to participate in another test or trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants in the experimental group undergo prehabilitation by reinfusion or retention enema of ileostomy contents filtrate. The filtrate is slowly infused 2 to 3 times a day for 15-20 minutes over 4 weeks. Adverse reactions such as abdominal pain, distension, and fever are observed and recorded daily along with weight and operation details.
Daily observations during the 4 weeks of prehabilitation
Duration - Variable according to standard care
Participants in the control group receive routine perioperative management without prehabilitation intervention.
Routine clinical visits as per standard care
Duration - Up to 12 months after surgery
Participants are monitored for intestinal function recovery, inflammation markers, bowel function, quality of life, fecal incontinence, weight changes, and complications related to stoma closure for up to 1 year after surgery.
Visits at 1 month, 3 months, 6 months, and 12 months after surgery, plus assessments up to 10 days post-surgery
Trial Site Locations
Total: 1 location
1
the Affiliated Hospital of Qingdao
Qingdao, Shandong, China, 266000
Actively Recruiting
Research Team
Y
Yanbing Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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