Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer (NCT05461248) | Clinical Trial Compass
CompletedNot Applicable
Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
China60 participantsStarted 2022-08-01
Plain-language summary
To analyze the occurrence of defecation complications, rectal function, and quality of life indicators after sphincter-preserving surgery for middle and low rectal cancer, the stoma exudate was collected before the stoma was restored, and the defecation complications, rectal function and quality of life indicators were evaluated. The effect of anal reinfusion of stoma discharge on the recovery of intestinal function in patients.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18\~75 years old, male or female;
. Pathological diagnosis of adenocarcinoma of the rectum on preoperative biopsy;
. Clinical staging was T1-4aN0-2M0;
. No distant multiple metastases;
. ECOG rating 0-2;
. Cardiac, pulmonary, hepatic and renal functions met the criteria for surgical tolerance
. Clinical diagnosis of middle and low rectal cancer, the lower edge of the tumour is within 10cm from the anal verge, and it is proposed to perform radical rectal surgery and prophylactic ileostomy at stage I, and intestinal closure at stage II;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients and their families were able to understand and willing to participate in this clinical study and signed an informed consent form.
Exclusion criteria
. Accompanied by other non-oncological conditions that make it impossible for the patient to continue to receive this treatment plan;
. After enrolment in the study, patients who required emergency surgery due to intestinal obstruction, perforation, or bleeding,et al. prior to stoma closure;
. Patients with pathologically confirmed distant metastases after rectal surgery, including liver, pelvis, ovary, peritoneum, and distant lymph node metastases;
. Intraoperative exploration for middle and low rectal cancer in anus-preserving surgery for those who need combined organ resection;
. After enrolment in the study, patients requested to withdraw from the study cohort for various reasons, or were unable to complete the study programme and follow-up for various reasons;
. Anastomotic fistula, severe anastomotic stenosis (inability to pass through enteroscopy or oesophageal finger and inability to dilate via oesophageal finger) after radical rectal surgery.