NCT06194708

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
May 2023Jan 2027

Study Start

First participant enrolled

May 15, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 8, 2024

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

December 22, 2023

Last Update Submit

December 22, 2023

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 1-year non-reversal rate of temporary stoma

    1 year after ostomy

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In-hospital rectal cancer patients who underwent radical resection of the primary lesion

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

May 15, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 8, 2024

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)