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

Launched by THE AFFILIATED HOSPITAL OF QINGDAO UNIVERSITY · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help patients with bowel function after surgery for rectal cancer. Specifically, it compares two methods of preparing the bowel before surgery: one involves reinfusing filtered contents from the ileostomy (a type of surgical opening in the abdomen) back into the bowel, while the other uses a retention enema (a liquid solution held in the bowel). The goal is to see if these methods can improve bowel function compared to traditional treatments after the stoma (the opening) is closed.

To be eligible for this trial, participants must be between 18 and 85 years old and have a good performance status, meaning they can carry out daily activities. They should also have been diagnosed with rectal cancer and undergone a specific type of surgery that includes creating an ileostomy. Participants can expect to receive either the new treatment or the standard care, and the trial is currently looking for volunteers. It's important to note that certain health conditions, such as severe heart problems or recent surgeries, may prevent someone from participating.

Gender

ALL

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).