NCT06216834

Brief Summary

Colorectal cancer is one of the leading cancers worldwide. Although the majority of CRC cases are typically diagnosed in individuals older than 50 years of age, recent international studies have highlighted the importance of younger adults (\< 50) are gradually increasing. Young cancer survivors often have poorer quality of life, disrupted social and sexual health, and increased mental health-related risks such as depression and anxiety. Especially for patients with rectal cancer, patients may suffer from sexual dysfunction, urinary system problems and loss of normal bowel function after radical resection of rectal tumors, and some patients may also need to undergo ostomy, which may have adverse effects on the quality of life and mental health of patients after surgery. Given that the incidence of colorectal cancer in young adults continues to rise worldwide, there is a need to better understand the impact of this particular disease on postoperative quality of life in young adults. This study intends to retrospectively analyze the clinical characteristics of the patients, and further summarize the impact of rectal cancer surgery on the quality of life of patients through follow-up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 11, 2024

Last Update Submit

January 11, 2024

Conditions

Keywords

Young-onset rectal cancerQuality of lifePsychosocial statusMuti-questionnaire

Outcome Measures

Primary Outcomes (2)

  • Quality-of-life scores

    patients' quality of life after surgery

    From September 2023 to September 2024

  • psychosocial status

    patients' psychosocial status after surgery

    From September 2023 to September 2024

Interventions

No intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young patients undergoing radical resection for rectal cancer

You may qualify if:

  • \. Preoperative colonoscopy and pathological examination were performed to confirm the pathological diagnosis of rectal cancer; 2. Abdominal and pelvic CT examination and MRI examination were performed before operation to carefully evaluate the extent of tumor invasion and whether there was distant metastasis. 3. The patient's clinical data (contact information, age, gender, hospitalization record, colonoscopy report, postoperative pathological report, operation record, informed consent) were recorded comprehensively; 4. Patients with R0 resection; 5. The patients are more than 18 years old and less than 50 years old.

You may not qualify if:

  • \. Patients with other malignant tumors; 2. Previous history of other malignant tumors; 3. Patients with inflammatory gastrointestinal disease; 4. Emergency surgery; 4. Patients with preoperative mental illness or cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250000, 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
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 22, 2024

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations