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OpenTrials
Completed

NCT Number: NCT04697303

Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

Understanding the quality of life and anorectal function changes in patients with middle and low rectal cancer after surgery can guide patients to recover after surgery and provide a valuable reference for surgeons in the selection of surgical methods. The purpose of this study is to: (1) Investigate the complication rate, recurrence and metastasis rate and survival of patients with middle and low rectal cancer. (2) QLQ-C30 and QLQ-CR29 questionnaires were used to assess the quality of life of patients with low- and middle-level rectal cancer at different periods after surgery. (3) Wexner constipation score and LARS syndrome score for anorectal function after operation for low rectal cancer. (4) The CIPE ejaculatory function score, IIEF-5 International Erectile Function Score, and FSFI-6 Female Sexual Function Index were used to assess the changes in sexual function of patients with low- and middle-position rectal cancer after surgery.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Jilin University First Hospital

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postoperative patients with middle rectal cancer
  • Postoperative patients with low rectal cancer

Exclusion criteria

(1)Patients refused to participate

Treatment and study plan

anorectal function test

Other

anorectal function test

Primary outcomes

  1. Overall survival

    Time frame: five years after the operation

    defined as time from the date of sugery to death

Secondary outcomes

  1. QLQ-C30

    Time frame: Every three months after the operation

    the score of Quality of life questionnaire QLQ-C30

  2. QLQ-CR29

    Time frame: Every three months after the operation

    the score of Quality of life questionnaire QLQ-C29

  3. Wexner

    Time frame: Every three months after the operation

    the score of questionnaire Wexner

  4. LARS

    Time frame: Every three months after the operation

    the score of questionnaire LARS

  5. IIEF-5

    Time frame: Every three months after the operation

    the score of questionnaire IIEF-5

  6. CIPE

    Time frame: Every three months after the operation

    the score of questionnaire CIPE

  7. FSFI-6

    Time frame: Every three months after the operation

    the score of questionnaire FSFI-6

Sponsors and collaborators

Lead sponsor

Quan Wang

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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