Clinical trial NCT06569966: 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
Official 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: A Single Center Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Anterior Resection Syndrome
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure.

Detailed description: The patients in the experimental group collected the contents of the ileostomyand placed in a wide mouth container, mixed with 500mL normal temperature saline, and placed in a funnel with double layer medical gauze. The filtrate of the ileal contents was collected and placed into an enema for use. The catheter was placed into the ileal output end of the ostomy through anterograde enema or transanal retention enema, and slowly infused for 15-20 minutes, 2-3 times a day for 4 weeks. The adverse reactions such as abdominal pain, abdominal distension and fever were observed. The number, time, antegrade/retrograde prehabilitation operation, adverse reactions during the operation and other special conditions were recorded every day, and the weight of the patient was recorded.Patients in the control group received routine perioperative management.

Eligibility criteria: Inclusion Criteria:

* aged 18-85 years old
* Karnofsky performance status (KPS)≥70%; Or ECOG score 2 points or less
* rectal cancer confirmed by preoperative pathology
* in the rectum resection before low, low colorectal anastomosis or after neoadjuvant therapy of patients
* prophylactic ileostomy.

Exclusion Criteria:

* cannot complete treatment
* the history of the anorectal surgery
* preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and functional constipation, etc.)
* postoperative anastomotic fistula and stricture
* during pregnancy or breastfeeding women
* with uncontrolled seizures, central nervous system disease or a history of mental disorders
* the last five years have other history of malignant disease cured except skin cancer and cervical carcinoma in situ
* clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association class II or worse 9) severe congestive heart failure or major arrhythmia requiring medical intervention, or myocardial infarction within the previous 6 months
* has a history of cerebral infarction or cerebral hemorrhage within the past 6 months
* organ transplantation requiring immunosuppressive therapy
* serious uncontrolled repeated infections, or other serious with disease of control;
* moderate or severe renal impairment creatinine clearance equal to or less than 50ml/min, or upper limit of normal (ULN)
* emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)
* in screening the first 4 weeks received study medication or treatment (to participate in other test).

Primary outcomes:
measure: The extent of low anterior resection syndrome
timeFrame: 1 month after discharge, and 3, 6, and 12 months after surgery
Secondary outcomes:
measure: the intestinal function recovery
timeFrame: up to 10 days after surgery
measure: Concentration of C-reactive protein
timeFrame: up to 10 days after surgery
measure: Quality of Life Questionnaire Core 30
timeFrame: 1 month after discharge, and 3, 6, and 12 months after surgery
measure: fecal incontinence
timeFrame: 1 month after discharge, and 3, 6, and 12 months after surgery
measure: Weight change after rehabilitation
timeFrame: From date of randomization until the date of stoma closure surgery, assessments usually take up to 3 months
measure: The number of emergency visits or rehospitalizations related to stoma closure
timeFrame: 1 year after surgery
measure: the incidence of postoperative intestinal obstruction (POI)
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Qingdao
country: China
facility: the Affiliated Hospital of Qingdao
state: Shandong
Study officials:
affiliation: the Affiliated Hospital of Qingdao
name: Yanbing Zhou
role: STUDY_CHAIR
References: