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
| NCT ID | NCT06569966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Hospital of Qingdao University |
| Condition | Low Anterior Resection Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 154 participants in total. It began in 2021-07-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Yanbing Zhou
STUDY CHAIR
the Affiliated Hospital of Qingdao
Frequently Asked Questions
Who can join the NCT06569966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Low Anterior Resection Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06569966 currently recruiting?
Yes, NCT06569966 is actively recruiting participants. Contact the research team at zhouyanbing@qduhospital.cn for enrollment information.
Where is the NCT06569966 trial being conducted?
This trial is being conducted at Qingdao, China.
Who is sponsoring the NCT06569966 clinical trial?
NCT06569966 is sponsored by The Affiliated Hospital of Qingdao University. The principal investigator is Yanbing Zhou at the Affiliated Hospital of Qingdao. The trial plans to enroll 154 participants.