Low Anterior Resection SyndromeNCT04114591
Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study
An observational study of Low Anterior Resection Syndrome and Cancer, run by University of Malta at 1 site in Malta.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome, Cancer, Quality of Life
- What is being tested?
- anterior resection
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 1 siteMalta
- Study dates
- 1 Jul 2018to 30 Jan 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- colorectal cancer (>15cm) from anal verge
- permanent stoma
- known disseminated or recurrent disease,
- patient without restitution of bowel continuity after 1 year
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Low Anterior Resection Syndrome, Cancer, Quality of Life
- Being tested
- anterior resection
- Medical subject headings
- Low Anterior Resection Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior resectionProcedure or surgery
Also called radiotherapy +/- chemotherapy
The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed
| Study group | Role | What they receive |
|---|---|---|
| LARS symptoms | Patient suffering from LARS as identified through LARS questionnaire Receives: Procedure: anterior resection | |
| No LARS symptoms | Absence of LARS symptoms Receives: Procedure: anterior resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARS incidence
Incidence of LARS in patients who had anterior resection
Measured: 1 year
Risk factors
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
Measured: 1 year
Life
The association between LARS and quality of life was assessed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Jul 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
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
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svetlana Doris Brincat, University of Malta
- Investigators
- Svetlana Doris Brincat, Principal investigator, Mater Dei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114591
- Sponsor's protocol ID
- S07/18
- Status last verified
- Oct 2019
- First submitted
- 25 Sep 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04114591
- Acronym / sponsor ID
- S07/18
- Conditions
- Low Anterior Resection Syndrome, Cancer, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 3 Oct 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LARS symptoms | – | Procedure: anterior resectionPatient suffering from LARS as identified through LARS questionnaire |
| No LARS symptoms | – | Procedure: anterior resectionAbsence of LARS symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- colorectal cancer (>15cm) from anal verge
- permanent stoma
- known disseminated or recurrent disease,
- patient without restitution of bowel continuity after 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior resectionAlso: radiotherapy +/- chemotherapyThe distance from anal verge, preoperative radiotherapy and presence of stoma were analysed | Procedure or surgery | LARS symptoms, No LARS symptoms |
Primary outcome
LARS incidence
Time frame: 1 year
Incidence of LARS in patients who had anterior resection
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
Life
Time frame: 1 year
The association between LARS and quality of life was assessed.
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 3 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
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.
Svetlana Doris Brincat principal investigator
Mater Dei Hospital
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 and Cancer, run by University of Malta at 1 site in Malta.
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 3 Oct 2019. 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 Malta. 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?
LARS incidence (time frame: 1 year). 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 3 Oct 2019.