Colon CancerACBCNCT04450758
Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma
An observational study of Colon Cancer, run by Skane University Hospital at 1 site in Sweden.
Trial summary
P) patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 \& 5 years overall survival Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Bridge to Surgery (stent or stoma)
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2020to 31 Dec 2031
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective observational cohort study.
Who may be able to join
- Age >18 years
- Symptomatic large bowel obstruction requiring acute intervention
- CT-verified colon obstruction due to colon cancer independent of presence of metastases
- Informed consent
Who cannot join
- Colonic perforation or bleeding
- Colonic obstruction of other origin than colon cancer
- Palliative situation
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
Göteborg University
Gothenburg
Jennifer Park, PhD MD, 031-3421000
Forskningssk, RN, 031-3421000
About this study
Official title: Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study
- patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 \& 5 years overall survival
Read the detailed description
The aim of this prospective observational study is to evaluate primary resection for malignant obstruction of the colon compared to only decompression as first intervention regarding postoperative outcomes. We hypothesize that patients with malignant obstruction benefit from avoidance of emergency cancer resection, by a two-stage procedure, with decompression by a stoma or stent as first intervention, leading to decreased short-term morbidity and mortality and improved long-term oncological outcome.
- Conditions
- Colon Cancer
- Being tested
- Bridge to Surgery (stent or stoma)
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridge to Surgery (stent or stoma)Procedure or surgery
The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure.
| Study group | Role | What they receive |
|---|---|---|
| resection | Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection. | |
| bridge to sugery | Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with bridge to surgery i.e. either stent or stoma and resection later on. Receives: Procedure: Bridge to Surgery (stent or stoma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with 30-day severe morbidity
Clavien-Dindo >3 within 30 days postop
Measured: 30 days
Overall survival after 3 years
survival unspecified
Measured: 3 years
Number of patients with 30 day mortality
death within 30 days
Measured: 30 days
Overall survival after 5 years
survival unspecified
Measured: 5 years
Number of patients with 90 day mortality
death within 90 days
Measured: 90 days
Secondary outcomes (16)
Number of patients with locally radical resections
resections regarded as R0
Measured: 90 days
Number of examined mesenteric lymph nodes
lymph nodes examined by pathologist
Measured: 90 days
Proportion of patients receiving neoadjuvant or adjuvant treatment
patients receiveing chemotherapy
Measured: 1 year
Proportion of patients with stomas after 3 years
patients with bowel continuity without stome
Measured: 3 years
Recurrence rate after 3 after years
relapse within 3 years
Measured: 3 years
Disease-free survival after 3 years
survival without disease relapse after 3 years
Measured: 3 years
Proportion of patients not being subjected to resection of initially decompressed
patients not proceeding to resection
Measured: 90 days
bridging interval
interval between stenting or stoma and resection
Measured: 90 days
Number of stent complications (perforations, migration, bleeding, success rate etc)
complications in stent group
Measured: 90 days
Number of stoma complications
complications in stoma group
Measured: 90 days
Morbidity and survival and impact of tumour location
30 day morbidity and mortality depending on tumour location i.e. right or left colon
Measured: 5 years
Number of laparoscopic resections
numbers of laparoscopic vs open resections
Measured: 90 days
Number of primary anastomosis
number of primary anastomosis in the Bridge to Surgery vs up front resection group
Measured: 90 days
Number of stomas after resection and type of stoma
number of stomas in Bridge to Surgery vs up front resection group
Measured: 90 days
total hospital stay in days
days in hospital in Bridge to Surgery vs up front resection
Measured: 90 days
colorectal surgeon performing resectional surgery
qualified colorectal surgeon, general surgeon or resident performing resectional surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Pamela Buchwald, Skane University Hospital
- Investigators
- Pamela Buchwald, PhD MD, Principal investigator, Skåne University Hospital, Lund UniversityTobias Axmarker, MD, Study chair, Skåne University Hospital, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450758
- Sponsor's protocol ID
- Skane University Hospital
- Acronym
- ACBC
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2020
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04450758
- Acronym / sponsor ID
- ACBC / Skane University Hospital
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Jun 2020 (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.
- patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 \& 5 years overall survival
Detailed description
The aim of this prospective observational study is to evaluate primary resection for malignant obstruction of the colon compared to only decompression as first intervention regarding postoperative outcomes. We hypothesize that patients with malignant obstruction benefit from avoidance of emergency cancer resection, by a two-stage procedure, with decompression by a stoma or stent as first intervention, leading to decreased short-term morbidity and mortality and improved long-term oncological outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resection | – | –Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection. |
| bridge to sugery | – | Procedure: Bridge to Surgery (stent or stoma)Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with bridge to surgery i.e. either stent or stoma and resection later on. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective observational cohort study.
Key inclusion criteria (4 listed)
- Age >18 years
- Symptomatic large bowel obstruction requiring acute intervention
- CT-verified colon obstruction due to colon cancer independent of presence of metastases
- Informed consent
Key exclusion criteria (3 listed)
- Colonic perforation or bleeding
- Colonic obstruction of other origin than colon cancer
- Palliative situation
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 |
|---|---|---|
| Bridge to Surgery (stent or stoma)The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure. | Procedure or surgery | bridge to sugery |
Primary outcome
Number of patients with 30-day severe morbidity
Time frame: 30 days
Clavien-Dindo >3 within 30 days postop
Overall survival after 3 years
Time frame: 3 years
survival unspecified
Number of patients with 30 day mortality
Time frame: 30 days
death within 30 days
Overall survival after 5 years
Time frame: 5 years
survival unspecified
Number of patients with 90 day mortality
Time frame: 90 days
death within 90 days
16 secondary outcomes
Number of patients with locally radical resections
Time frame: 90 days
Number of examined mesenteric lymph nodes
Time frame: 90 days
Proportion of patients receiving neoadjuvant or adjuvant treatment
Time frame: 1 year
Proportion of patients with stomas after 3 years
Time frame: 3 years
Recurrence rate after 3 after years
Time frame: 3 years
Disease-free survival after 3 years
Time frame: 3 years
Proportion of patients not being subjected to resection of initially decompressed
Time frame: 90 days
bridging interval
Time frame: 90 days
Number of stent complications (perforations, migration, bleeding, success rate etc)
Time frame: 90 days
Number of stoma complications
Time frame: 90 days
Morbidity and survival and impact of tumour location
Time frame: 5 years
Number of laparoscopic resections
Time frame: 90 days
Number of primary anastomosis
Time frame: 90 days
Number of stomas after resection and type of stoma
Time frame: 90 days
total hospital stay in days
Time frame: 90 days
colorectal surgeon performing resectional surgery
Time frame: 90 days
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 23 Apr 2026.
- Individual participant dataSharing planned: Yes
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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, PhD MD principal investigator
Skåne University Hospital, Lund University
Tobias Axmarker, MD study chair
Skåne University Hospital, Lund University
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 Colon 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 4 inclusion and 3 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 23 Apr 2026. 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 Pamela Buchwald, PhD MD (004640331000, pamela.buchwald@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with 30-day severe morbidity (time frame: 30 days). The study lists 5 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 23 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.