NCT05445245

Brief Summary

The aims are to identify the trajectory of LAR Syndrome and explore the adaptation process and coping strategies of LAR Syndrome in patients newly diagnosed with rectal cancer. The participants will recruit from a CRC surgical outpatient department of a medical center in northern Taiwan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

June 30, 2022

Last Update Submit

February 12, 2025

Conditions

Rectal Cancer

Keywords

low anterior resection syndromepsychological distressquality of liferectal cancer

Outcome Measures

Primary Outcomes (1)

  • Self-report Questionnaire

    show the specific trajectory of LAR Syndrome, psychological distress, and fecal incontinence-related QoL based on different tumor locations in patients with rectal cancer

    Change from baseline symptom at 12 months

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rectal cancer patients during therapy.

You may qualify if:

  • Patients with stage I to III rectal cancer.
  • Patients already know their condition.
  • \. Aged 20 years and older. 5. Consciously communicate in Mandarin or Taiwanese. 6. Agreed with the interview and had signed the permit.

You may not qualify if:

  • Patients with Stage IV rectal cancer.
  • Recurred rectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Gung University

Taoyuan, Kwei-Shan Dist., 333, Taiwan

Location

MeSH Terms

Conditions

Rectal NeoplasmsLow Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 6, 2022

Study Start

April 14, 2022

Primary Completion

December 31, 2024

Study Completion

January 24, 2025

Last Updated

February 14, 2025

Record last verified: 2024-02

Locations

TW(1)