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 range18 Years – 75 Years
SexALL
See this in plain English?
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;
✓. 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.