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Application of disintegrating stent in situ colonic bypass instead ileal protective ostomy in middle and low rectal cancer surgery

Application of disintegrating stent in situ colonic bypass instead ileal protective ostomy in middle and low rectal cancer surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078052
Enrollment
Unknown
Registered
2023-11-28
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

Bracket diversion group:A disintegrating intestinal stent was implanted in the colo-intestinal lumen at the proximal end of the rectal anastomosis, and the intestinal contents were directly diverted o
Ileostomy group:After rectum resection and anastomosis, the ileum at 25-30cm away from the ileocecal part was proposed for double cavity stomy

Sponsors

Chongqing University Fuling Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: ?. Preoperative colonoscopy and biopsy confirmed primary single rectal cancer without distant metastasis ?. The lower margin of the tumor is less than 10cm from the anal margin, and it is preliminarily estimated that the anus can be preserved before surgery, and there is a need for protective ileal stoma ?. Eastern Cooperative Oncology Group(ECOG)performance status score =2 ?. The subjects voluntarily participated in the clinical study and signed the informed consent for surgery

Exclusion criteria

Exclusion criteria: ?.Serious damage to cardiopulmonary function or other underlying diseases that cannot tolerate surgery ?.Other diseases involving the rectum, such as familial colorectal polyposis, active Crohn's disease or active ulcerative colitis. ?.Complicated with intestinal obstruction requires emergency operation ?.pregnant women ?.Overweight, BMI>35kg/m2 ?.Change the surgical method for various reasons, quit midway, and did not complete the entire treatment process ?.Patients who refused to sign informed consent to participate in the trial

Design outcomes

Primary

MeasureTime frame
Reoperation rate due to anastomotic leakage;

Secondary

MeasureTime frame
Anastomotic leakage;wound infection;abdominal infection;water and electrolyte disturbance;renal function impairment;operation time;Intraoperative blood loss;First postoperative exhaust time;postoperative fasting time;total hospitalization time;total hospitalization cost;Cleveland Clinic Colorectal Cancer Quality of Life Questionnaire CCF-CaQL;European Cancer Research for Treatment Tissue Colorectal Cancer Specific Quality of Life Questionnaire 29 QLQ-CR29;

Countries

China

Contacts

Public Contactchenxuan

Chongqing University Fuling Hospital

cx610@163.com+86 181 6652 0872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026