The Longitudinal Study of Low Anterior Resection Syndrome in Patients with Newly Diagnosed Rectal Cancer.

The Longitudinal Study of Low Anterior Resection Syndrome, Psychological Distress, and Fecal Incontinence-related Quality of Life in Patients with Newly Diagnosed Rectal Cancer.

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Taiwan
  • Kwei-Shan Dist.
    • Taoyuan City, Kwei-Shan Dist., Taiwan, 333
      • Chung Gung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Rectal cancer patients during therapy.

Description

Inclusion Criteria:

1. Patients with stage I to III rectal cancer.
2. Patients already know their condition.

4. Aged 20 years and older. 5. Consciously communicate in Mandarin or Taiwanese. 6. Agreed with the interview and had signed the permit.

Exclusion Criteria:

1. Patients with Stage IV rectal cancer.
2. Recurred rectal cancer.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; rectal cancer; low anterior resection syndrome; psychological distress
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Low Anterior Resection Syndrome; Rectal Neoplasms
• Other Study ID Numbers: 202101979B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No