Low Anterior Resection SyndromeNCT03215017
Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery
A study testing Transanal irrigation and Medication in people with Low Anterior Resection Syndrome, run by Mirna Abraham-Nordling at 3 sites in Sweden.
Trial summary
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Transanal irrigation and Medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesSweden
- Study dates
- 15 May 2017to 1 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection)
- Adult ≥ 18 years old
- Have scoring major LARS (according to the Low anterior resection syndrome score)
Who cannot join
- stoma
- recurrent disease
- Another colorectal surgery
- Inflammatory bowel disease (IBD)
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Danderyd Hospital
Stockholm
Karolinska University Hospital
Stockholm
Stockholm South General Hospital
Stockholm
About this study
Official title: A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.
Read the detailed description
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer.
The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.
An interim analysis will be made after 40 included patients in the study.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Transanal irrigation, Medication
- Medical subject headings
- Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal irrigationDevice
Also called Peristeen® anal irrigation system - Coloplast
Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast
MedicationDrug
Also called One or a combination of Loperamide, Sorbitol, Sterculia gum
Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)
| Study group | Role | What they receive |
|---|---|---|
| Transanal irrigation | Experimental | Manual transanal irrigation to control bowel function. Receives: Device: Transanal irrigation |
| Medication | Active comparator | Medication to control bowel function. Receives: Drug: Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel function
Cleveland incontinence questionnaire
Measured: 1 year
Bowel function, Low anterior resection syndrome (LARS)
Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function)
Measured: 1 year
Secondary outcomes (1)
Quality of Life (QoL)
Assessed using EORTC Quality of life questionnaire (QLQ)-C30
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 posted12 Jul 2017
- Study start15 May 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirna Abraham-Nordling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mirna Abraham-Nordling, Karolinska Institutet
- Investigators
- Mirna Abraham-Nordling, MD.PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215017
- Sponsor's protocol ID
- 2017/551-31
- Status last verified
- Mar 2023
- First submitted
- 1 Jul 2017
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pieniowski EHA, Bergstrom CM, Nordenvall CAM, Westberg KS, Johar AM, Tumlin Ekelund SF, Larsson KR, Pekkari KJ, Jansson Palmer GC, Lagergren P, Abraham-Nordling M. A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery. Ann Surg. 2023 Jan 1;277(1):30-37. doi: 10.1097/SLA.0000000000005482. Epub 2022 Jul 7.
PubMed 35797618
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03215017
- Acronym / sponsor ID
- 2017/551-31
- Conditions
- Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mirna Abraham-NordlingUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Jul 2017 (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.
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.
Detailed description
A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer.
The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.
An interim analysis will be made after 40 included patients in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal irrigation | Experimental | Device: Transanal irrigationManual transanal irrigation to control bowel function. |
| Medication | Active comparator | Drug: MedicationMedication to control bowel function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection)
- Adult ≥ 18 years old
- Have scoring major LARS (according to the Low anterior resection syndrome score)
Key exclusion criteria (4 listed)
- stoma
- recurrent disease
- Another colorectal surgery
- Inflammatory bowel disease (IBD)
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 |
|---|---|---|
| Transanal irrigationAlso: Peristeen® anal irrigation system - ColoplastEffect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast | Device | Transanal irrigation |
| MedicationAlso: One or a combination of Loperamide, Sorbitol, Sterculia gumMedication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum) | Drug | Medication |
Primary outcome
Bowel function
Time frame: 1 year
Cleveland incontinence questionnaire
Bowel function, Low anterior resection syndrome (LARS)
Time frame: 1 year
Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function)
1 secondary outcome
Quality of Life (QoL)
Time frame: 1 year
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 9 Mar 2023.
- Background: PubMed 35797618Pieniowski EHA, Bergstrom CM, Nordenvall CAM, Westberg KS, Johar AM, Tumlin Ekelund SF, Larsson KR, Pekkari KJ, Jansson Palmer GC, Lagergren P, Abraham-Nordling M. A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery. Ann Surg. 2023 Jan 1;277(1):30-37. doi: 10.1097/SLA.0000000000005482. Epub 2022 Jul 7.
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.
Mirna Abraham-Nordling, MD.PhD principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal irrigation and Medication in people with Low Anterior Resection Syndrome, run by Mirna Abraham-Nordling at 3 sites in Sweden.
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 3 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 9 Mar 2023. 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 Sweden. 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?
Bowel function (time frame: 1 year). The study lists 2 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 NCT03215017, which also lists 1 linked publication.
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 9 Mar 2023.