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Completed

NCT Number: NCT04114591

Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study

This study adds to the understanding of the contributing factors leading to LARS, the long term effects of this syndrome post-operatively and its impact on quality of life.

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Key information

Who can participate

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

Inclusion criteria

  • All adult patients >18 years, under the care of all surgical firms at Mater Dei Hospital, who had undergone anterior resection for rectal cancer between January 2014 and December 2016

Exclusion criteria

  • colorectal cancer (>15cm) from anal verge
  • permanent stoma
  • known disseminated or recurrent disease,
  • patient without restitution of bowel continuity after 1 year

Treatment and study plan

anterior resection

Procedure

The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed

Other names: radiotherapy +/- chemotherapy

Primary outcomes

  1. LARS incidence

    Time frame: 1 year

    Incidence of LARS in patients who had anterior resection

  2. Risk factors

    Time frame: 1 year

    Variable factors which might have contributed to LARS were the following:

    • Age
    • Gender
    • Diabetes mellitus
    • Pathological stage
    • MRI stage
    • Distance from anal verge
    • Surgical technique
    • Preoperative radiotherapy
    • Preoperative chemotherapy
    • Postoperative radio/chemotherapy
    • Type of anastomosis
    • Presence of stoma
    • Interval from stoma reversal
    • Duration of follow-up
  3. Life

    Time frame: 1 year

    The association between LARS and quality of life was assessed.

Sponsors and collaborators

Lead sponsor

University of Malta

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2019
Registry last updated
Oct 3, 2019

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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