Low Anterior Resection SyndromeNCT05020132
Bowel Dysfunction After Rectal Cancer Treatment
An observational study of Low Anterior Resection Syndrome, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Low Anterior Resection Syndrome
- How many people
- 113 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2015to 1 Sep 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anterior resection for rectal adenocarcinoma with curative intention, with or without neoadjuvant chemoradiotherapy
Who may be able to join
- 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.
Who cannot join
- disseminated disease
- surgery with palliative intent
- refusal to participate in the study
- intellectual difficulty to answer the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of 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.
Read the detailed description
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.
- Conditions
- Low Anterior Resection Syndrome
- Medical subject headings
- Low Anterior Resection Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the LARS score between baseline and 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.
Measured: 12 months
Change in the MSK-BFI between baseline and 12 months (MSK-BFI)
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.
Measured: 12 months
Change in the Bristol stool chart between baseline and 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).
Measured: 12 months
Secondary outcomes (5)
Change in the Visual Analogue Scale (VAS) between baseline and 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)
Measured: 12 months
Change in the EORTC QLQ-C30 between baseline and 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.
Measured: 12 months
Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 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.
Measured: 12 months
Correlation of the severity of LARS with the quality of life
Correlation of the severity of LARS (LARS score and MSK-BFI) with the quality of life (EORTC QLQ-C30)
Measured: 12 months
Multivariate analysis of risk factors for LARS
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Nov 2015
- Primary completion30 Sep 2018
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Responsible party
- Principal investigator, Yolanda Ribas, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020132
- Sponsor's protocol ID
- LARS
- Status last verified
- Sep 2023
- First submitted
- 17 Aug 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Bowel Dysfunction After Rectal Cancer Treatment
- ClinicalTrials.gov ID
- NCT05020132
- Acronym / sponsor ID
- LARS
- Conditions
- Low Anterior Resection Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anterior resection for rectal adenocarcinoma with curative intention, with or without neoadjuvant chemoradiotherapy
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- disseminated disease
- surgery with palliative intent
- refusal to participate in the study
- intellectual difficulty to answer the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
5 secondary outcomes
Change in the Visual Analogue Scale (VAS) between baseline and 12 months
Time frame: 12 months
Change in the EORTC QLQ-C30 between baseline and 12 months
Time frame: 12 months
Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months
Time frame: 12 months
Correlation of the severity of LARS with the quality of life
Time frame: 12 months
Multivariate analysis of risk factors for LARS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Anterior Resection Syndrome, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the LARS score between baseline and 12 months (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.