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
- Conditions
- Low Anterior Resection Syndrome
- Registration Number
- NCT06569966
- Lead Sponsor
- The Affiliated Hospital of Qingdao University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 154
Inclusion Criteria:<br><br> - aged 18-85 years old<br><br> - Karnofsky performance status (KPS)=70%; Or ECOG score 2 points or less<br><br> - rectal cancer confirmed by preoperative pathology<br><br> - in the rectum resection before low, low colorectal anastomosis or after neoadjuvant<br> therapy of patients<br><br> - prophylactic ileostomy.<br><br>Exclusion Criteria:<br><br> - cannot complete treatment<br><br> - the history of the anorectal surgery<br><br> - preoperative bowel dysfunction such as diarrhea, irritable bowel syndrome and<br> functional constipation, etc.)<br><br> - postoperative anastomotic fistula and stricture<br><br> - during pregnancy or breastfeeding women<br><br> - with uncontrolled seizures, central nervous system disease or a history of mental<br> disorders<br><br> - the last five years have other history of malignant disease cured except skin cancer<br> and cervical carcinoma in situ<br><br> - clinically significant (i.e., active) heart disease, such as symptomatic coronary<br> artery disease, New York Heart Association class II or worse 9) severe congestive<br> heart failure or major arrhythmia requiring medical intervention, or myocardial<br> infarction within the previous 6 months<br><br> - has a history of cerebral infarction or cerebral hemorrhage within the past 6 months<br><br> - organ transplantation requiring immunosuppressive therapy<br><br> - serious uncontrolled repeated infections, or other serious with disease of control;<br><br> - moderate or severe renal impairment creatinine clearance equal to or less than<br> 50ml/min, or upper limit of normal (ULN)<br><br> - emergency surgery due to tumor emergencies (bleeding, perforation, obstruction)<br><br> - in screening the first 4 weeks received study medication or treatment (to<br> participate in other test).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The extent of low anterior resection syndrome
- Secondary Outcome Measures
Name Time Method the intestinal function recovery;Concentration of C-reactive protein;Quality of Life Questionnaire Core 30;fecal incontinence;Weight change after rehabilitation;The number of emergency visits or rehospitalizations related to stoma closure;the incidence of postoperative intestinal obstruction (POI)