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Completed

NCT Number: NCT05020132

Bowel Dysfunction After Rectal Cancer Treatment

Bowel dysfunction after rectal cancer treatment may significantly affect the quality of life. Our study aimed to estimate the incidence and characterize the Low Anterior Resection Syndrome(LARS). We performed a prospective evaluation of patients treated with anterior resection for rectal cancer at two hospitals. Assessment was performed at baseline, after neoadjuvant treatment, and 1, 6 and 12 months after bowel transit reconstruction using the following scores: Bristol scale, LARS score, MSK-BFI, FIQL, EORTC-QLQ30 and a visual analogue scale.

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

Low anterior resection syndrome (LARS) refers to wide-ranging symptoms including evacuatory dysfunction, fecal urgency and incontinence. The assessment of bowel dysfunction after rectal cancer treatment has improved since the development of the LARS score. This score has widely been used with a meta-analysis reporting a pooled prevalence of "major LARS" of 41%. However, several studies have found a large proportion of patients with major LARS in the general population without rectal cancer raising questions about the specificity of this score. Moreover, most studies on the prevalence of LARS do not include a baseline evaluation and, therefore, may not allow establishing whether the dysfunctions appeared after the treatment. Consequently, we considered that a prospective study including a baseline evaluation and multiple validated questionnaires was required. The present study aimed to estimate the incidence and characterize bowel dysfunction after rectal cancer treatment. The results of this study will be useful to improve the preoperative information given to the patient and the shared decision-making process.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with anterior resection for rectal adenocarcinoma with curative intention, with or without neoadjuvant chemoradiotherapy, total or partial excision of the mesorectum, colorectal or coloanal anastomosis.

Exclusion criteria

  • disseminated disease
  • surgery with palliative intent
  • refusal to participate in the study
  • intellectual difficulty to answer the questionnaires

Treatment and study plan

Primary outcomes

  1. Change in the LARS score between baseline and 12 months

    Time frame: 12 months

    Change in the LARS score (Low Anterior Resection Score) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The LARS score is a 5-item scoring system which classifies patients into three severity categories: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). A higher score represents worse bowel function. This score also includes a question about the impact on quality of life.

  2. Change in the MSK-BFI between baseline and 12 months (MSK-BFI)

    Time frame: 12 months

    Change in the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (MSK-BFI) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The MSK-BFI includes 18 questions with five frequency options ranging from never through to always. A total score and three subscales (frequency, diet, and urgency) can be calculated. A higher score represents better bowel function.

  3. Change in the Bristol stool chart between baseline and 12 months

    Time frame: 12 months

    Change in the Bristol stool chart between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The Bristol stool chart shows seven categories of stool. The Bristol score was subclassified into three categories: Bristol 1-2 (hard stools), Bristol 3-4 (normal stools), and Bristol 5-7 (loose or liquid stools).

Secondary outcomes

  1. Change in the Visual Analogue Scale (VAS) between baseline and 12 months

    Time frame: 12 months

    Change in the Visual Analogue Scale (VAS) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The VAS ranges from 0 (worst bowel function) to 10 (best)

  2. Change in the EORTC QLQ-C30 between baseline and 12 months

    Time frame: 12 months

    Change in the European Organization for Research and Treatment of Cancer Quality oF Life Questionnaire (EORTC QLQ-C30) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The EORTC QLQ-C30 is a self-administered questionnaire developed to assess the quality of life of patients with cancer. The global QoL scale and 5 functional scales (physical, role, cognitive, emotional, and social functioning) can be calculated. All scales range from 0 to 100. A higher score for the global health status represents a higher quality of life, and a higher score for a functional scale represents a higher / healthy level of functioning.

  3. Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months

    Time frame: 12 months

    Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The FIQL score includes 29 items which form four scales: lifestyle, coping/behavior, depression/self-perception, and embarrassment. Scores range from 0 to 4 and a higher value represents a better quality of life.

  4. Correlation of the severity of LARS with the quality of life

    Time frame: 12 months

    Correlation of the severity of LARS (LARS score and MSK-BFI) with the quality of life (EORTC QLQ-C30)

  5. Multivariate analysis of risk factors for LARS

    Time frame: 12 months

    Assessment of independent predictors of the LARS score at the 12-month visit in a multiple linear regression model. Univariate linear regression analysis was initially performed to identify the demographic, clinical and surgical factors associated with the 12-month LARS score.

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Collaborators

  • Hospital Mutua de Terrassa

Registry information

Official study title

Prospective Evaluation of Bowel Dysfunction After Rectal Cancer Treatment

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Aug 25, 2021
Registry last updated
Sep 28, 2023

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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