Prehabilitation treatment for bowel function in patients with ileostomy before stoma closure

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

This study is testing if a new treatment using ileostomy fluid can help improve bowel function in patients with ileostomies before their stomas are closed, compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT06569966 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the effects of preoperative prehabilitation using ileostomy contents filtrate reinfusion or retention enema against traditional treatment in patients with Low Anterior Resection Syndrome. Participants in the experimental group will undergo a regimen involving the collection and infusion of ileostomy filtrate to improve bowel function post-stoma closure. The study will monitor adverse reactions and record various parameters daily over a four-week period. The control group will receive standard perioperative management without the experimental intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with rectal cancer who have undergone prophylactic ileostomy and have a Karnofsky performance status of 70% or higher.

Not a fit: Patients with preoperative bowel dysfunction, a history of anorectal surgery, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve bowel function and quality of life for patients undergoing stoma closure.

How similar studies have performed: While this specific approach is novel, similar prehabilitation strategies have shown promise in improving postoperative outcomes in other surgical contexts.

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).

Where this trial is running

Qingdao, Shandong

• the Affiliated Hospital of Qingdao — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Yanbing Zhou

Conditions Low Anterior Resection Syndrome