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New treatment option for Low Anterior Resection Syndrome
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
ClinicalTrials.gov ID: NCT06569966
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Qingdao, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Qingdao, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.