LARS - Low Anterior Resection SyndromePhase 3iRECOVERNCT06936774
Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance
A Phase 3 study testing Intensified follow-up program in people with LARS - Low Anterior Resection Syndrome and Rectal Cancer Surgery, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
Trial summary
The goal of this clinical study is to gain further insights into the treatment of patients with Low Anterior Resection Syndrome (LARS) symptoms after rectal resection. The main question is: Can LARS symptoms and quality of life be improved by implementing an intensified follow-up program? Researchers will compare the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LARS - Low Anterior Resection Syndrome, Rectal Cancer Surgery, Rectal Cancer
- What is being tested?
- Intensified follow-up program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 1 Dec 2025to 1 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 older than 18 years
- patients with rectal cancer in the middle and lower third of the rectum in stages I to IV who underwent LAR with TME and protective ileostomy
- able to give informed consent as documented by signature
Who cannot join
- dementia or other psychiatric disorder that would prevent the patients from answering the questionnaires and experiencing sustainable training effects
- impossibility of stoma reversal due to persistent anastomotic leak and/or local recurrence
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Recruiting
Clarunis Universitäres Bauchzentrum Basel
Basel, 4002
- Recruiting
Lindenhofspital Bern
Bern
Dominik Jakob, 0041 31 632 59 00, dominik.jakob@insel.ch
- Not yet recruiting
St. Anna Spital Bern
Bern
local PI
- Recruiting
Kantonsspital Luzern
Lucerne
Jörn Markus Gass, 041 205 45 39, markus.gass@luks.ch
- Recruiting
Kantonsspital Winterthur
Winterthur
Benjamin Weixler, 004152 266 20 40, viszeralchirurgie@ksw.ch
About this study
Official title: Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)
The goal of this clinical study is to gain further insights into the treatment of patients with Low Anterior Resection Syndrome (LARS) symptoms after rectal resection. The main question is: Can LARS symptoms and quality of life be improved by implementing an intensified follow-up program? Researchers will compare the results of the intervention group with the results of a control group in which patients do not receive an intensified follow-up program to determine whether the intervention works. Participants will undergo an intensified follow-up program which consists of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints.
Read the detailed description
Background: After surgical treatment of patients with rectal cancer, up to 65% experience a symptom complex known as LARS (Low Anterior Resection Syndrome). Those affected suffer from symptoms such as fecal incontinence, frequent bowel movements and a strong urge to defecate, which can severely impair their quality of life. Therapy options include treatment with medication such as bulking agents or drugs that reduce bowel motility, pelvic floor muscle training or stimulation of the nerves that control the function of the rectum and pelvic floor.
Objective: The aim of the present study is to investigate whether an intensified follow-up program can improve the LARS symptoms and consequently the quality of life of patients after rectal resection. If the planned study shows success of the program, we will be able to structurally improve the aftercare of those affected.
Methods: The study is being conducted at several centers in Switzerland, including St. Claraspital Basel. Patients who have had a rectal resection are recruited prior to the repositioning of the artificial bowel outlet, which was created during the primary operation, and randomly assigned to one of the both study groups (intensified follow-up or standard treatment). The symptoms are recorded using various questionnaires and patients will be treated according to our action plan. If LARS symptoms occur, patients receive drug treatment, pelvic floor physiotherapy and, if necessary, sacral neurostimulation, which means implanting a device which stimulates the nerves that control the function of the rectum and pelvic floor. If patients suffer from urinary problems or impaired sexual function they will be referred to our urology or gynecology department for further diagnosis and treatment.
- Conditions
- LARS - Low Anterior Resection Syndrome, Rectal Cancer Surgery, Rectal Cancer, Quality of Life (QOL)
- Being tested
- Intensified follow-up program
- Keywords
- LARS, Low Anterior Resection Syndrome, Intensified follow-up, Rectal cancer, Rectal resection, Low anterior resection
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified follow-up programOther
The study intervention will be an intensified follow-up program which consists of different measures. Patients will attend follow-up visits 1, 4, 7 and 13 months after ileostomy repositioning, at which LARS symptoms, quality of life as well as sexual and urinary function will be recorded using various questionnaires. In case of LARS symptoms patients will receive medical treatment with loperamide and metamucil as well as pelvic floor muscle training (including biofeedback and home exercises). Regarding pelvic floor muscle training we are planning nine sessions instructed by physiotherapy staff. In case of therapy-resistant LARS symptoms after 6 months sacral neurostimulation is offered to the patients with a focus on incontinence symptoms and desire for surgery or transanal irrigation in patients with a focus on voiding disorders. In case of urinary and sexual complaints patients are referred to our urology or gynaecology department for further diagnostic and treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intensified follow-up program consisting of of several follow-up visits at 1, 4, 7 and 13 months and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints which will be recorded using questionnaires. Receives: Other: Intensified follow-up program |
| Control group | No intervention | Treatment according to standard guidelines, recording of symptoms using questionnaires at 1 and 13 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the LARS score after 13 months
The primary outcome is the change of the LARS score after participation for 13 months in an intensified follow-up program compared to standard treatment which means patients are only treated if they present themselves in our consultation hours due to complaints. The LARS score is recorded using the LARS score questionnaire, developed 2012 by Emmertson et al.. The LARS score consists of five questions on the topics incontinence for flatus, incontinence for liquid stools, frequency of bowel movements, clustering of stools and urgency. Each answer results in a number of points, those points are summarized in the end to give a total score. This score is categorized into a range of no LARS (score 21 and lower), minor LARS (score 21 - 29) and major LARS (score 30 - 42).
Measured: 13 months after closure of ileostomy
Secondary outcomes (10)
Patients' quality of life (QoL)
Patients' quality of life will be recorded using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer (EORTC-QLQ-CR29) which will be filled out by the patients before closure of ileostomy as well as 1, 4, 7 and 13 months after closure of ileostomy.
Maximum score is 140 points, minimum score 35 points. Higher scores mean worse outcomes.
Measured: 1, 4, 7 and 13 months after closure of ileostomy
Urinary symptoms in women and men
Urinary symptoms in women and men will be recorded using the American Urological Association Symptom Index (AUA-SI) which is a validated questionnaire for urinary symptoms in women and men.
Maximum score is 35 points, minimum score 0 points. Higher scores mean worse outcomes.
Measured: 1, 4, 7 and 13 months after closure of ileostomy
Sexual function in women
Sexual function in women will be recorded using the International Consultation on Incontinence Questionnaire Female Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-FLUTSsex) which is a validated questionnaire for sexual complaints in women.
Maximum score is 14 points, minimum score 0 points. Higher scores mean worse outcomes.
Measured: 1, 4, 7 and 13 months after closure of ileostomy
Sexual function in men
Sexual function in men will be recorded using the International Index of Erectile Dysfunction (IIEF-5) which is a validated questionnaire for sexual complaints in men.
Maximum score is 25 points, minimum score 5 points. Higher scores mean better outcomes.
Measured: 1, 4, 7 and 13 months after closure of ileostomy
Readmission to hospital
Measured: 13 months
Costs
Measured: 13 months
Compliance to treatment intervention
Recording of drop-outs, patients refusing to participate in interventions, tolerance of the medication and recording of side effects.
Measured: 13 months
Natural history of incidence of LARS symptoms in control group
Incidence of LARS symptoms will be measured by the LARS score. The LARS score consists of five questions on the topics incontinence for flatus, incontinence for liquid stools, frequency of bowel movements, clustering of stools and urgency. Each answer results in a number of points, those points are summarized in the end to give a total score. This score is categorized into a range of no LARS (score 21 and lower), minor LARS (score 21 - 29) and major LARS (score 30 - 42).
Measured: 13 months
Prevalence of LARS
Measured: 13 months
Rate of secondary ostomy formation
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Dec 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LARS - Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: Intensified follow-up program consisting of of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints which will be recorded using questionnaires. Control group: Treatment according to standard, recording of symptoms using questionnaires only at beginning and end of the study period.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- St. Claraspital AG, Clarunis - Universitäres Bauchzentrum Basel
- Responsible party
- Sponsor
- Investigators
- Daniel Steinemann, Deputy chief physician, Study chair, Clarunis - Universitäres Bauchzentrum Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936774
- Sponsor's protocol ID
- iRECOVER_2025
- Acronym
- iRECOVER
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
PubMed 22504191Roberts RO, Jacobsen SJ, Jacobson DJ, Reilly WT, Talley NJ, Lieber MM. Natural history of prostatism: high American Urological Association Symptom scores among community-dwelling men and women with urinary incontinence. Urology. 1998 Feb;51(2):213-9. doi: 10.1016/s0090-4295(97)00505-0.
PubMed 9495700Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
PubMed 10637462
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)
- ClinicalTrials.gov ID
- NCT06936774
- Acronym / sponsor ID
- iRECOVER / iRECOVER_2025
- Conditions
- LARS - Low Anterior Resection Syndrome, Rectal Cancer Surgery, Rectal Cancer, Quality of Life (QOL)
- Keywords
- LARS, Low Anterior Resection Syndrome, Intensified follow-up, Rectal cancer, Rectal resection, Low anterior resection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- St. Claraspital AG, Clarunis - Universitäres Bauchzentrum Basel
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Apr 2025 (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.
The goal of this clinical study is to gain further insights into the treatment of patients with Low Anterior Resection Syndrome (LARS) symptoms after rectal resection. The main question is: Can LARS symptoms and quality of life be improved by implementing an intensified follow-up program? Researchers will compare the results of the intervention group with the results of a control group in which patients do not receive an intensified follow-up program to determine whether the intervention works. Participants will undergo an intensified follow-up program which consists of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints.
Detailed description
Background: After surgical treatment of patients with rectal cancer, up to 65% experience a symptom complex known as LARS (Low Anterior Resection Syndrome). Those affected suffer from symptoms such as fecal incontinence, frequent bowel movements and a strong urge to defecate, which can severely impair their quality of life. Therapy options include treatment with medication such as bulking agents or drugs that reduce bowel motility, pelvic floor muscle training or stimulation of the nerves that control the function of the rectum and pelvic floor.
Objective: The aim of the present study is to investigate whether an intensified follow-up program can improve the LARS symptoms and consequently the quality of life of patients after rectal resection. If the planned study shows success of the program, we will be able to structurally improve the aftercare of those affected.
Methods: The study is being conducted at several centers in Switzerland, including St. Claraspital Basel. Patients who have had a rectal resection are recruited prior to the repositioning of the artificial bowel outlet, which was created during the primary operation, and randomly assigned to one of the both study groups (intensified follow-up or standard treatment). The symptoms are recorded using various questionnaires and patients will be treated according to our action plan. If LARS symptoms occur, patients receive drug treatment, pelvic floor physiotherapy and, if necessary, sacral neurostimulation, which means implanting a device which stimulates the nerves that control the function of the rectum and pelvic floor. If patients suffer from urinary problems or impaired sexual function they will be referred to our urology or gynecology department for further diagnosis and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group: Intensified follow-up program consisting of of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints which will be recorded using questionnaires. Control group: Treatment according to standard, recording of symptoms using questionnaires only at beginning and end of the study period.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intensified follow-up programIntensified follow-up program consisting of of several follow-up visits at 1, 4, 7 and 13 months and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints which will be recorded using questionnaires. |
| Control group | No intervention | –Treatment according to standard guidelines, recording of symptoms using questionnaires at 1 and 13 months. |
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 older than 18 years
- patients with rectal cancer in the middle and lower third of the rectum in stages I to IV who underwent LAR with TME and protective ileostomy
- able to give informed consent as documented by signature
Key exclusion criteria (2 listed)
- dementia or other psychiatric disorder that would prevent the patients from answering the questionnaires and experiencing sustainable training effects
- impossibility of stoma reversal due to persistent anastomotic leak and/or local recurrence
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 |
|---|---|---|
| Intensified follow-up programThe study intervention will be an intensified follow-up program which consists of different measures. Patients will attend follow-up visits 1, 4, 7 and 13 months after ileostomy repositioning, at which LARS symptoms, quality of life as well as sexual and urinary function will be recorded using various questionnaires. In case of LARS symptoms patients will receive medical treatment with loperamide and metamucil as well as pelvic floor muscle training (including biofeedback and home exercises). Regarding pelvic floor muscle training we are planning nine sessions instructed by physiotherapy staff. In case of therapy-resistant LARS symptoms after 6 months sacral neurostimulation is offered to the patients with a focus on incontinence symptoms and desire for surgery or transanal irrigation in patients with a focus on voiding disorders. In case of urinary and sexual complaints patients are referred to our urology or gynaecology department for further diagnostic and treatment. | Other | Intervention group |
Primary outcome
Improvement of the LARS score after 13 months
Time frame: 13 months after closure of ileostomy
The primary outcome is the change of the LARS score after participation for 13 months in an intensified follow-up program compared to standard treatment which means patients are only treated if they present themselves in our consultation hours due to complaints. The LARS score is recorded using the LARS score questionnaire, developed 2012 by Emmertson et al.. The LARS score consists of five questions on the topics incontinence for flatus, incontinence for liquid stools, frequency of bowel movements, clustering of stools and urgency. Each answer results in a number of points, those points are summarized in the end to give a total score. This score is categorized into a range of no LARS (score 21 and lower), minor LARS (score 21 - 29) and major LARS (score 30 - 42).
10 secondary outcomes
Patients' quality of life (QoL)
Time frame: 1, 4, 7 and 13 months after closure of ileostomy
Urinary symptoms in women and men
Time frame: 1, 4, 7 and 13 months after closure of ileostomy
Sexual function in women
Time frame: 1, 4, 7 and 13 months after closure of ileostomy
Sexual function in men
Time frame: 1, 4, 7 and 13 months after closure of ileostomy
Readmission to hospital
Time frame: 13 months
Costs
Time frame: 13 months
Compliance to treatment intervention
Time frame: 13 months
Natural history of incidence of LARS symptoms in control group
Time frame: 13 months
Prevalence of LARS
Time frame: 13 months
Rate of secondary ostomy formation
Time frame: 13 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 22504191Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
- Background: PubMed 9495700Roberts RO, Jacobsen SJ, Jacobson DJ, Reilly WT, Talley NJ, Lieber MM. Natural history of prostatism: high American Urological Association Symptom scores among community-dwelling men and women with urinary incontinence. Urology. 1998 Feb;51(2):213-9. doi: 10.1016/s0090-4295(97)00505-0.
- Background: PubMed 10637462Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
- Quality of life questionnaire (EORTC-QLQ-CR29 for colorectal cancer)Link provided by the sponsor.
- ICIQ-FLUTSsex (questionnaire for sexual complaints in women)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Steinemann, Deputy chief physician study chair
Clarunis - Universitäres Bauchzentrum Basel
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensified follow-up program in people with LARS - Low Anterior Resection Syndrome and Rectal Cancer Surgery, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
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 2 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felicitas Wiedemann, Resident (+41 61 777 76 09, felicitasinga.wiedemann@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the LARS score after 13 months (time frame: 13 months after closure of ileostomy). 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 NCT06936774, which also lists 3 linked publications.
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 6 May 2026.