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

NCT ID: NCT06194708

Last Updated: 2024-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mid-low rectal cancer patients with temporary stoma after radical surgery

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiao Yi

Role: primary

+86 13366036387

Other Identifiers

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COCG-02

Identifier Type: -

Identifier Source: org_study_id

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