Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）

Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）on Behalf of Chinese Ostomy Collaboration Group (COCG-02)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06194708

Enrollment

235

Registered

2024-01-08

Start date

2023-05-15

Completion date

2027-01-01

Last updated

2024-01-08

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

Conditions

Rectal Cancer

Brief summary

The goal of this observational study is to learn about in mid-low rectal patients who received temporary ostomies after surgery of the primary tumors. The main questions it aims to answer are: * To explore the proportion of temporary stomas that cannot be reversed after radical surgery for mid-low rectal cancer and their main causes. * To use the basic information we collected from patients before and during surgery to develop an individualized model for predicting the time of stoma reversal and explore the risk factors affecting stoma reversal.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Pathologically confirmed as rectal adenocarcinoma; * The tumor is located within 12cm from the anal verge; * Primary tumor is radically resected; * The patient received a temporary ostomy during the in-hospital visit of the resection of the primary tumor.

Exclusion criteria

* The stoma was initially recognized as permanent stoma; * Patients with distant metastasis; * Patients with multi-primary colorectal cancer.

Design outcomes

Primary

Measure	Time frame
1-year non-reversal rate of temporary stoma	1 year after ostomy

Countries

China

Outcome results