Low Anterior Resection SyndromeLARS-AustriaNCT05506111

Low Anterior Resection Syndrome After Rectum Resection for Rectal Carcinoma.

An observational study of Low Anterior Resection Syndrome and Quality of Life, run by Paracelsus Medical University at 3 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Anterior Resection Syndrome, Quality of Life, Incontinence
How many people: 100 participants
Where: 3 sitesAustria
Study dates: 18 Jul 2022to 31 Jul 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All consecutive patients with a bioptically verified rectal carcinoma ≤16 cm from anocutaneous line) can be included in the study. Patients will be included only after the indication for further therapy has been established in the tumor board according to guideline criteria and after signing the informed consent form.

Who may be able to join

Age: 18 to 99 years
Patients with biopsy-verified rectal cancer.
Patients scheduled for elective sphincter-preserving rectal surgery
Patients scheduled for neoadjuvant RCTx (Chemo-radiation) (concept: short course radiation, conv.
fractionated RCTx, total neoadjuvant therapy(TNT))
Signed consent (ICF)

Who cannot join

Patients younger than 18 years
Patients without signed informed consent
Metastatic carcinoma
terminal colostomy ( APR (abdominoperineal resection),...)

Trial locations and contacts

3 sites in 1 country.

Jaroslav Presl, Dr. contact

00435725555847

j.presl@salk.at

Felix Aigner, Prof. Dr. contact

Felix.Aigner@bbgraz.at

Austria3 sites, 3 recruiting

Department of Surgery Hospital of St. John of God, Graz
Graz, 8020
Felix Aigner, Prof. Dr.
Recruiting
Department of Surgery, Paracelsus Medical University
Salzburg, 5020
Jaroslav Presl, Dr., 00435725555847, j.presl@salk.at
Recruiting
Department of Surgery Medical University Vienna
Vienna, 1090
Stefan Riss, Prof. Dr.
Recruiting

Other trials in Austria

About this study

Official title: Erfassung Des Low Anterior Resection Syndroms Nach Rektumresektion Bei Patienten Mit Einem Rektumkarzinom - Eine österreichweite Multi-center Studie

The ACO-ASSO (Austrian Society of Surgical Oncology) colorectal group and Austrian Working Group for Coloproctology present the LARS Austria study. It is a prospective, multicenter observational study. The primary objective of this study is to collect information about LARS (LARS score) and QoL (EORTC -CR29) in patients with non-metastatic rectal cancer who received therapy. As a secondary objective, the impact of radiotherapy on the occurrence of LARS will be investigated.

Read the detailed description

All consecutive patients with biopsy verified rectal cancer (≤16cm from anocutaneous line) can be included in the study. For the study, tumors whose aboral margin, when measured with a rigid rectoscope, is 16 cm or less from the anocutaneous line will be included. Thus, only histologically verified tumors of the lower (<6 cm), middle (6<12 cm) and upper (12-16cm) rectal thirds are included.

Patients will be included after the indication for further therapy has been established in the tumor board according to guideline criteria and after signing the participation consent. The collection of study relevant data will be performed according to the following scheme:

Group 1 = patients without neoadjuvant radiochemotherapy (RCHT). Collection of data and questionnaires before surgery and 3, 6, and 12 months after index surgery (if no protective stoma).

OR Collection of data and questionnaires before surgery and 3, 6, or 12 months after stoma re-operation (if protective stoma).

Group 2 = patients with neoadjuvant RCHT/ definitive RCHT=watch and wait. Collection of data and questionnaires before RCHT and before surgery or after RCHT and 3, 6, or 12 months after index surgery (if no protective stoma).

OR Collection of data and questionnaires before RCHT and before operation=surgery(OP) or after RCHT and 3, 6 or 12 months after stoma closure (if protective stoma) OR Collection of data and questionnaires before RCHT and 3, 6 and 12 months after RCHT (if no surgery)

Conditions: Low Anterior Resection Syndrome, Quality of Life, Incontinence
Medical subject headings: Low Anterior Resection Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
Measured: 3 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
Measured: 6 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
Measured: 12 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait

Secondary outcomes (1)

Assessing the difference in LARS Score between the time of the diagnoses (baseline)and after the chemoradiation to identify the impact of the neoadjuvant Chemo-Radiation on LARS.
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
Measured: At the time of the diagnosis (baseline) and 6 to 8 weeks after an Chemo-Radiation, directly before the surgery respectively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 202231 Jul 2024

First posted18 Aug 2022
Study start18 Jul 2022
Primary completion31 Jul 2024 (estimated)
Study completion31 Jul 2024 (estimated)

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: 100 participants (estimated)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05506111
Sponsor's protocol ID: 1110/2021
Acronym: LARS-Austria
Status last verified: Aug 2022
First submitted: 22 Jul 2022
Last updated: 19 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Jaroslav Presl, Dr.

00435725555847

j.presl@salk.at

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Low Anterior Resection Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Erfassung Des Low Anterior Resection Syndroms Nach Rektumresektion Bei Patienten Mit Einem Rektumkarzinom - Eine österreichweite Multi-center Studie
ClinicalTrials.gov ID: NCT05506111
Acronym / sponsor ID: LARS-Austria / 1110/2021
Conditions: Low Anterior Resection Syndrome, Quality of Life, Incontinence
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Paracelsus Medical UniversityUniversity, hospital or other
Collaborators: Department of Surgery Hospital of St. John of God, Graz, Medical University of Vienna
Study start: 18 Jul 2022 (actual)
Primary completion: 31 Jul 2024 (estimated)
Study completion: 31 Jul 2024 (estimated)
First posted: 18 Aug 2022 (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.

Detailed description

Group 1 = patients without neoadjuvant radiochemotherapy (RCHT). Collection of data and questionnaires before surgery and 3, 6, and 12 months after index surgery (if no protective stoma).

OR Collection of data and questionnaires before surgery and 3, 6, or 12 months after stoma re-operation (if protective stoma).

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All consecutive patients with a bioptically verified rectal carcinoma ≤16 cm from anocutaneous line) can be included in the study. Patients will be included only after the indication for further therapy has been established in the tumor board according to guideline criteria and after signing the informed consent form.

Key inclusion criteria (6 listed)

Age: 18 to 99 years
Patients with biopsy-verified rectal cancer.
Patients scheduled for elective sphincter-preserving rectal surgery
Patients scheduled for neoadjuvant RCTx (Chemo-radiation) (concept: short course radiation, conv.
fractionated RCTx, total neoadjuvant therapy(TNT))

Key exclusion criteria (4 listed)

Patients younger than 18 years
Patients without signed informed consent
Metastatic carcinoma
terminal colostomy ( APR (abdominoperineal resection),...)

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

Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
Time frame: 3 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
Time frame: 6 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)
Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection.
Time frame: 12 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait
Occurrence of Low Anterior Resection Syndrome (LARS) will be measured with an LARS Score. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points)

1 secondary outcome

Assessing the difference in LARS Score between the time of the diagnoses (baseline)and after the chemoradiation to identify the impact of the neoadjuvant Chemo-Radiation on LARS.
Time frame: At the time of the diagnosis (baseline) and 6 to 8 weeks after an Chemo-Radiation, directly before the surgery respectively.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.

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.

Jaroslav Presl, Dr. contact

00435725555847

j.presl@salk.at

Felix Aigner, Prof. Dr. contact

Felix.Aigner@bbgraz.at

Stefan Riss, Prof. Dr. study chair

Medical University Wien, Department of Surgery

Felix Aigner, Prof. Dr. study director

Department of Surgery Hospital of St. John of God, Graz

Jaroslav Presl, Dr. principal investigator

Paracelsus Medical University Salzburg, Department of Surgery

3 sites 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 Quality of Life, run by Paracelsus Medical University at 3 sites in Austria.

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 6 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: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jaroslav Presl, Dr. (00435725555847, j.presl@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of Low Anterior Resection Syndrome (LARS) after anterior rectal resection. (time frame: 3 months after the rectum resection or after the closure of a protective ileostomy or after an Chemoradiation in case of watch and wait). 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?

On the ClinicalTrials.gov record for NCT05506111.

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 19 Aug 2022.