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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Xiao Yi

CONTACT

[email protected]

+86 13366036387

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

1-year non-reversal rate of temporary stoma

Time frame: 1 year after ostomy

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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)

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Jan 8, 2024
Registry last updated: Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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