Laparoscopic SurgeryNCT05005117
Laparoscopic Approach for Emergency Colon Resection
A study testing Laparoscopic operation and Open operation in people with Laparoscopic Surgery and Colorectal Cancer, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Laparoscopic Surgery, Colorectal Cancer, Colorectal Disorders
- What is being tested?
- Laparoscopic operation and Open operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteFinland
- Study dates
- 17 Sep 2021to 30 Jul 2031
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients in need of emergency colon resection
Who cannot join
- age < 18 year
- trauma patients
- reoperations
- acute pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial
This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.
Read the detailed description
Laparoscopic technique in elective colorectal surgery has been shown to be advantageous for patients compared to open technique. However, the feasibility and potential benefits of laparoscopic colorectal surgery in emergency setting has not been evaluated sufficiently.
The aim of this study is to compare laparoscopic and open technique in emergency colon resections. Primary outcome is the immediate recovery after operation and secondary outcome is long-term overall and cancer-specific survival.
- Conditions
- Laparoscopic Surgery, Colorectal Cancer, Colorectal Disorders, Emergencies, Complication of Surgical Procedure, Long-term Effects of Cancer Treatment
- Being tested
- Laparoscopic operation, Open operation
- Keywords
- Laparoscopic surgery, Emergency surgery, Colorectal
- Medical subject headings
- Colorectal Neoplasms, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic operationProcedure or surgery
Operation
Open operationProcedure or surgery
Operation
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic operation | Experimental | Laparoscopic emergency colon resection Receives: Procedure: Laparoscopic operation |
| Open operation | Active comparator | Open emergency colon resection Receives: Procedure: Open operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morbidity
Postoperative morbidity evaluated by Clavien-Dindo classification
Measured: 30 days
Secondary outcomes (2)
Surgical site infections
Surgical site infections, superficial and deep
Measured: 30 days
Long-term Survival
Long-term overall and cancer-specific survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start17 Sep 2021
- Primary completion30 Jul 2031 (estimated)
- Study completion30 Jul 2031 (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 Laparoscopic SurgeryStudies 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
- This is a prospective randomized controlled multicenter trial
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Kanta-Häme Central Hospital
- Responsible party
- Sponsor
- Investigators
- Marie T Grönroos-Korhonen, MD, Principal investigator, Päijät Häme Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005117
- Sponsor's protocol ID
- Q048
- Status last verified
- Feb 2026
- First submitted
- 30 Jul 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gronroos-Korhonen MT, Kossi JAO. LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection-a multicenter, open label, randomized controlled trial. Trials. 2024 Apr 17;25(1):268. doi: 10.1186/s13063-024-08058-0.
PubMed 38632602
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05005117
- Acronym / sponsor ID
- Q048
- Conditions
- Laparoscopic Surgery, Colorectal Cancer, Colorectal Disorders, Emergencies, Complication of Surgical Procedure, Long-term Effects of Cancer Treatment
- Keywords
- Laparoscopic surgery, Emergency surgery, Colorectal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Kanta-Häme Central Hospital
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 13 Aug 2021 (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.
This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.
Detailed description
Laparoscopic technique in elective colorectal surgery has been shown to be advantageous for patients compared to open technique. However, the feasibility and potential benefits of laparoscopic colorectal surgery in emergency setting has not been evaluated sufficiently.
The aim of this study is to compare laparoscopic and open technique in emergency colon resections. Primary outcome is the immediate recovery after operation and secondary outcome is long-term overall and cancer-specific survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized controlled multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic operation | Experimental | Procedure: Laparoscopic operationLaparoscopic emergency colon resection |
| Open operation | Active comparator | Procedure: Open operationOpen emergency colon resection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients in need of emergency colon resection
Key exclusion criteria (4 listed)
- age < 18 year
- trauma patients
- reoperations
- acute pancreatitis
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 |
|---|---|---|
| Laparoscopic operationOperation | Procedure or surgery | Laparoscopic operation |
| Open operationOperation | Procedure or surgery | Open operation |
Primary outcome
postoperative morbidity
Time frame: 30 days
Postoperative morbidity evaluated by Clavien-Dindo classification
2 secondary outcomes
Surgical site infections
Time frame: 30 days
Long-term Survival
Time frame: 5 years
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 22 Apr 2026.
- Derived from this study: PubMed 38632602Gronroos-Korhonen MT, Kossi JAO. LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection-a multicenter, open label, randomized controlled trial. Trials. 2024 Apr 17;25(1):268. doi: 10.1186/s13063-024-08058-0.
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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. This study is not recruiting at the moment.
Marie T Grönroos-Korhonen, MD principal investigator
Päijät Häme Central 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 Laparoscopic operation and Open operation in people with Laparoscopic Surgery and Colorectal Cancer, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 22 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 Finland. 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?
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?
postoperative morbidity (time frame: 30 days). 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 NCT05005117, 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 22 Apr 2026.