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A randomized, controlled, prospective study of the use of a catheter in the prevention of ostomy obstruction after terminal ileostomy

A randomized, controlled, prospective study of the use of a catheter in the prevention of ostomy obstruction after terminal ileostomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040017
Enrollment
Unknown
Registered
2020-11-18
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

rectal cancer

Interventions

Experimental group:The stoma was opened in phase 1 and catheterized
Control group:The stoma was routinely opened in phase 1 without catheterization

Sponsors

The Fifth Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with rectal cancer confirmed by colonoscopy or non-invasive criteria were diagnosed according to NCCN guidelines; 2. Aged 18 to 85, male or female; 3. No distant metastasis was found; 4. Willing to accept laparoscopic low anterior resection for rectal cancer (LAR) and preventative terminal ileostomy (LP); 5. Be able to understand the situation of this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who had undergone gastrointestinal surgery in the past 1 year; 2. Patients with other malignant tumors or distant metastasis; 3. Patients with one or more of the following conditions: (1) Patients with symptomatic central nervous system metastases or spinal cord compression; (2) Serous cavity effusions with clinical symptoms and symptomatic treatment (including pleural effusions, ascites, pericardial effusions); (3) Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, acute myocardial infarction, congestive heart failure (NYHA Grade II and above), child-pugh grade B (7 or above) or Grade C in liver function, kidney or metabolic disease); 4. HIV patients; 5. Persons with a history of substance abuse and unable to quit, or with physical or mental disorders, and unable to participate in clinical trials; 6. Genetic or acquired bleeding and thrombotic tendencies known to exist (e.g. hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 7. Pregnant and lactating women; 8. The researchers believe that the subjects may not be able to complete the study or comply with the requirements of the study. (for management reasons or other reasons).

Design outcomes

Primary

MeasureTime frame
Incidence of ostomy obstruction;Incidence of adverse events and serious adverse events and laboratory examination indicators;

Secondary

MeasureTime frame
First exhaust time of postoperative stoma;Time of first eating after operation;The first time to get out of bed after operation;Postoperative drainage tube removal time;Postoperative hospital stay;Incidence of other complications of stoma;

Countries

China

Contacts

Public ContactSu Yong-Hui

The Fifth Affiliated Hospital of Sun Yat-Sen University

suyh@mail.sysu.edu.cn+86 13326699169

Outcome results

None listed

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