Laparoscopic Approach for Emergency Colon Resection | NCT05005117

Studies
Laparoscopic Approach for Emergency Colon Resection

NCT05005117

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Status

Active, not recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

192Estimated

Phase

Not Applicable

Conditions

Laparoscopic Surgery
Colorectal Cancer
Colorectal Disorders
Emergencies
Complication of Surgical Procedure
Long-term Effects of Cancer Treatment

Interventions

Laparoscopic operation
Open operation

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 17, 2021Actual

Primary Completion Date

Jul 30, 2031Estimated

Completion Date

Jul 30, 2031Estimated

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Aug 12, 2021

First Posted Date

Aug 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 22, 2026Actual

Name	Class
Kanta-Häme Central Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

192Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic operation	Experimental	Laparoscopic emergency colon resection	Procedure: Laparoscopic operation
Open operation	Active Comparator	Open emergency colon resection	Procedure: Open operation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic operation	Procedure	Operation	Laparoscopic operation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative morbidity	Postoperative morbidity evaluated by Clavien-Dindo classification	30 days

Secondary Outcomes

Measure	Description	Time Frame
Surgical site infections	Surgical site infections, superficial and deep	30 days
Long-term Survival	Long-term overall and cancer-specific survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients in need of emergency colon resection

Exclusion Criteria:

age < 18 year
trauma patients
reoperations
acute pancreatitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie T Grönroos-Korhonen, MD	Päijät Häme Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marie Grönroos-Korhonen		Lahti		15850	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38632602	Derived	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.

ID	Term
D015179	Colorectal Neoplasms
D004630	Emergencies

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D000074432	Sphincterotomy
D000074433	Myotomy