NCT05461248Completed
Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
An Exploratory Study on the Recovery of Intestinal Flora and Intestinal Function by Preventing Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 14 Jul 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 30 May 2024
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Colorectal cancer
- NCT number
- NCT05461248
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Aug 2022 to the primary completion date, 30 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Accompanied by other non-oncological conditions that make it impossible for the patient to continue to receive this treatment plan;
- Intraoperative exploration for middle and low rectal cancer in anus-preserving surgery for those who need combined organ resection;
- Anastomotic fistula, severe anastomotic stenosis (inability to pass through enteroscopy or oesophageal finger and inability to dilate via oesophageal finger) after radical rectal surgery.
Lab values
- 1\. Previous history of malignant colorectal tumour or recently diagnosed combination of other malignant tumours; 2、Patients with combined intestinal obstruction, intestinal perforation, intestinal haemorrhage, etc. requiring emergency surgery; 3. Neighbouring organs requiring combined organ removal; 4. ASA classification ≥ Grade IV and/or ECOG physical status score \> 2; 5. Those who have serious liver and kidney dysfunction, cardiopulmonary dysfunction, coagulation dysfunction or combined serious basic diseases cannot tolerate the surgery; 6. Have a history of serious mental illness; 7. Pregnant or breastfeeding women; 8. Those who have a history of taking steroid drugs; 9. Patients with other clinical and laboratory conditions considered by the investigator to be inappropriate for participation in the trial; 10. One week before the operation, there are signs of infection, body temperature rises \>37.5°C, blood WBC \>10.0×109/L; 11. History of antibiotic use 1 week prior to surgery (excluding preoperative shock medication); 12. Preoperative neoadjuvant patients
Other
- Exit criteria
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jilin University First Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.