Rectal CancerSELSANCT06214988
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
A study testing selective approach defunctioning stoma in people with Rectal Cancer, run by Skane University Hospital at 1 site in Sweden.
Trial summary
The goal of this observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- selective approach defunctioning stoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2024to 31 Dec 2030
- Phase
- Interventional
- 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
- Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach
- Additional inclusion criteria for randomised part of the study:
- Patients aged less than 80 years
- Patients with American Society of Anesthetists' (ASA) fitness grade I or II as determined by the anaesthesiologist or the surgeon
- Patients without clear radiological signs of distant disease before rectal cancer surgery (previous metastatic surgery is no exclusion criterion)
- Anastomotic leak risk score of 0-1
- Willingness to be randomised
Who cannot join
- Insufficient command of Swedish, Norwegian, Danish or English to understand questionnaires or consent
- Emergency rectal resection (tumour resection due to large bowel obstruction, perforation, etc)
- Pregnancy or breastfeeding Additional exclusion criteria for randomised part of the study
- Previous pelvic irradiation (due to e.g. gynaecological or urological cancer)
- Preoperative tumour perforation or pelvic sepsis
- Beyond TME surgery and/or concurrent resection of other organ
Show all 18Show fewer
- Concurrent corticosteroid treatment (prednisone-equivalent dosage ≥10 mg daily)
- Planned postoperative chemotherapy
- Smoking not completely ceased four weeks before surgery
- Excessive alcohol consumption with social and medical consequences (as judged by the surgeon in charge) Intraoperative exclusion criteria for randomised part of the study
- ->2 staple firings for rectal transection
- Intraoperative blood loss ≥250 ml for minimally invasive surgery
- Intraoperative blood loss ≥500 ml for open or converted surgery
- More than one intraabdominal anastomosis performed
- Incomplete doughnuts
- Air-leak test positive
- Any significant intraoperative adverse event at the discretion of the operating surgeon (e.g. ureterotomy, bowel or tumour perforation, major medical event - pulmonary embolism, cardiac arrhythmia) (Gawria, 2022)
- TME with anastomosis ultimately not done
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Malmö
Pamela Buchwald, MD PhD, pamela.buchwald@med.lu.se
About this study
Official title: SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
The goal of this observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients. The primary outcome is a hybrid so-called textbook outcome; stoma-free survival at two years without major LARS, reflecting a functionally appropriate outcome after low anterior resection for rectal cancer. Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery.
Read the detailed description
Systematic use of defunctioning stoma after low anterior resection for rectal cancer has been shown to reduce symptomatic anastomotic leakage and associated interventions. However, accumulating data suggest that this comes at the price of worse bowel dysfunction, a higher rate of permanent stomas and kidney injury. We aim to study whether a selective strategy of defunctioning stoma use might lead to fewer adverse consequences, while still being safe for patients.
This is a multicentre international prospective trial including a non-blinded randomised clinical trial. All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible. Patients enter a prospective observational study, in which a randomised clinical trial is nested. Patients eligible for randomisation are aged below 80 years, have an American Society of Anesthesiologists' fitness grade I or II, have no unresected distant disease, and have a predicted lower risk of anastomotic leakage. Patients will be randomised 1:1 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma. The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use. The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients.
This study has been approved by Ethical Review Authority in Sweden (2023-04347-01) and seeks permission in Norway and Danmark, respectively. The results will be disseminated through patient associations, popular science, the broader medical community, and conventional scientific channels.
- Conditions
- Rectal Cancer
- Being tested
- selective approach defunctioning stoma
- Keywords
- anterior resection, defunctioning stoma, selective approach
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective approach defunctioning stomaProcedure or surgery
With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.
| Study group | Role | What they receive |
|---|---|---|
| selective approach to defunctioning stoma | Experimental | With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed. Receives: Procedure: selective approach defunctioning stoma |
| routine use of defunctioning stoma | No intervention | With randomisation to this control arm (systematic approach), a defunctioning stoma is constructed using the marked stoma site. A loop ileostomy is fashioned using an ileal loop close to the ileocecal valve, while a loop colostomy can be derived from either the transverse or a redundant left colon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
textbook outcome; stoma-free survival at two years without major LARS
extant stoma, alive, and a LARS score at 30 or lesn has stabilised as well for those without a stoma in situ.
no extant stoma, alive, and a LARS score at 30 or less at the time point two years after the anterior resection.
Measured: 2 year
Secondary outcomes (14)
Anastomotic leakage
ISREC grading
Measured: 1,3,12 and 24 months
Complications
Clavien-Dinco
Measured: 1,3,12 and 24 months
Length of hospital stay
total days in hospital
Measured: until discharge within 90 days
Postoperative mortality
death
Measured: 3 months
Major Low Anterior Resection Syndrome
domain score scale 0-42 points, >30 points indicate a bad functional outcome i.e. major LARS
Measured: 12 and 24 months
Quality of life by European Organization for Research and Treatment of Cancer- ColoRectal 29 (EORTC-CR29)
EORTC-CR29 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 12 and 24 months
Quality of Recovery-15 Swedish (QoR15swe)
Difference from baseline in total score 0-150 points, higher value indicating faster recovery
Measured: 1 month
Adjuvant chemotherapy for high-risk patients
Clinical assessment categorisation
Measured: 12 months
Renal function
Creatinine (mg/L)
Measured: 12 and 24 months
Stay out of hospital
total days of alive and out of hospital
Measured: 24 months
Stoma in situ
proportion
Measured: 24 months
Recurrence (local and distant)
Clinical assessment categorisation
Measured: 36 and 60 months
Overall survival
Clinical assessment categorisation
Measured: 36 and 60 months
Quality of life by European Organization for Research and Treatment of Cancer- Cancer30 (EORTC-C30)
EORTC-C30 domain scores in scales 0-100 points, a high score for the global health status /quality of life represents a high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
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 Rectal CancerStudies 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
- Model description
- Observational trial with nested randomized trial
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University, Lund University, Göteborg University, Ersta Hospital, Sweden, Copenhagen University Hospital at Herlev, Linkoeping University, Oslo University Hospital, Örebro University, Sweden
- Responsible party
- Principal investigator, Pamela Buchwald, Skane University Hospital
- Investigators
- Pamela Buchwald, MD PhD, Principal investigator, Skåne University Hospital, Lund UniversityMartin Rutegård, MD PhD, Principal investigator, Umeå University Hospital, Umeå University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214988
- Sponsor's protocol ID
- 2023-0437-01
- Acronym
- SELSA
- Status last verified
- May 2025
- First submitted
- 17 Dec 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified raw data may be shared upon request.
Publications
Rutegard M, Lindskold M, Jorgren F, Landerholm K, Matthiessen P, Forsmo HM, Park J, Rosenberg J, Schultz J, Seeberg LT, Segelman J, Buchwald P. SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision. Colorectal Dis. 2025 Feb;27(2):e70009. doi: 10.1111/codi.70009.
PubMed 39887540
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06214988
- Acronym / sponsor ID
- SELSA / 2023-0437-01
- Conditions
- Rectal Cancer
- Keywords
- anterior resection, defunctioning stoma, selective approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Umeå University, Lund University, Göteborg University, Ersta Hospital, Sweden, Copenhagen University Hospital at Herlev, Linkoeping University, Oslo University Hospital, Örebro University, Sweden
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jan 2024 (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 observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients. The primary outcome is a hybrid so-called textbook outcome; stoma-free survival at two years without major LARS, reflecting a functionally appropriate outcome after low anterior resection for rectal cancer. Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery.
Detailed description
Systematic use of defunctioning stoma after low anterior resection for rectal cancer has been shown to reduce symptomatic anastomotic leakage and associated interventions. However, accumulating data suggest that this comes at the price of worse bowel dysfunction, a higher rate of permanent stomas and kidney injury. We aim to study whether a selective strategy of defunctioning stoma use might lead to fewer adverse consequences, while still being safe for patients.
This is a multicentre international prospective trial including a non-blinded randomised clinical trial. All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible. Patients enter a prospective observational study, in which a randomised clinical trial is nested. Patients eligible for randomisation are aged below 80 years, have an American Society of Anesthesiologists' fitness grade I or II, have no unresected distant disease, and have a predicted lower risk of anastomotic leakage. Patients will be randomised 1:1 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma. The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use. The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients.
This study has been approved by Ethical Review Authority in Sweden (2023-04347-01) and seeks permission in Norway and Danmark, respectively. The results will be disseminated through patient associations, popular science, the broader medical community, and conventional scientific channels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Observational trial with nested randomized trial
| Arm | Type | Receives |
|---|---|---|
| selective approach to defunctioning stoma | Experimental | Procedure: selective approach defunctioning stomaWith randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed. |
| routine use of defunctioning stoma | No intervention | –With randomisation to this control arm (systematic approach), a defunctioning stoma is constructed using the marked stoma site. A loop ileostomy is fashioned using an ileal loop close to the ileocecal valve, while a loop colostomy can be derived from either the transverse or a redundant left colon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach
- Patients aged less than 80 years
- Patients with American Society of Anesthetists' (ASA) fitness grade I or II as determined by the anaesthesiologist or the surgeon
- Patients without clear radiological signs of distant disease before rectal cancer surgery (previous metastatic surgery is no exclusion criterion)
- Anastomotic leak risk score of 0-1
Key exclusion criteria (18 listed)
- Insufficient command of Swedish, Norwegian, Danish or English to understand questionnaires or consent
- Emergency rectal resection (tumour resection due to large bowel obstruction, perforation, etc)
- Pregnancy or breastfeeding Additional exclusion criteria for randomised part of the study
- Previous pelvic irradiation (due to e.g. gynaecological or urological cancer)
- Preoperative tumour perforation or pelvic sepsis
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 |
|---|---|---|
| selective approach defunctioning stomaWith randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed. | Procedure or surgery | selective approach to defunctioning stoma |
Primary outcome
textbook outcome; stoma-free survival at two years without major LARS
Time frame: 2 year
extant stoma, alive, and a LARS score at 30 or lesn has stabilised as well for those without a stoma in situ. no extant stoma, alive, and a LARS score at 30 or less at the time point two years after the anterior resection.
14 secondary outcomes
Anastomotic leakage
Time frame: 1,3,12 and 24 months
Complications
Time frame: 1,3,12 and 24 months
Length of hospital stay
Time frame: until discharge within 90 days
Postoperative mortality
Time frame: 3 months
Major Low Anterior Resection Syndrome
Time frame: 12 and 24 months
Quality of life by European Organization for Research and Treatment of Cancer- ColoRectal 29 (EORTC-CR29)
Time frame: 12 and 24 months
Quality of Recovery-15 Swedish (QoR15swe)
Time frame: 1 month
Adjuvant chemotherapy for high-risk patients
Time frame: 12 months
Renal function
Time frame: 12 and 24 months
Stay out of hospital
Time frame: 24 months
Stoma in situ
Time frame: 24 months
Recurrence (local and distant)
Time frame: 36 and 60 months
Overall survival
Time frame: 36 and 60 months
Quality of life by European Organization for Research and Treatment of Cancer- Cancer30 (EORTC-C30)
Time frame: 12 and 24 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 21 May 2025.
- Derived from this study: PubMed 39887540Rutegard M, Lindskold M, Jorgren F, Landerholm K, Matthiessen P, Forsmo HM, Park J, Rosenberg J, Schultz J, Seeberg LT, Segelman J, Buchwald P. SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision. Colorectal Dis. 2025 Feb;27(2):e70009. doi: 10.1111/codi.70009.
- Individual participant dataSharing planned: Yes. Unidentified raw data may be shared upon request.
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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.
Pamela Buchwald, MD PhD principal investigator
Skåne University Hospital, Lund University
Martin Rutegård, MD PhD principal investigator
Umeå University Hospital, Umeå University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selective approach defunctioning stoma in people with Rectal Cancer, run by Skane University Hospital at 1 site 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 7 inclusion and 18 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 21 May 2025. 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 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?
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 Caroline Nilsson, RN (004640331000, caroline.n.nilsson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
textbook outcome; stoma-free survival at two years without major LARS (time frame: 2 year). 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 NCT06214988, 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 21 May 2025.