NCT05005117

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
64mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Sep 2021Jul 2031

First Submitted

Initial submission to the registry

July 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 17, 2021

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2031

Last Updated

April 22, 2026

Status Verified

February 1, 2026

Enrollment Period

9.9 years

First QC Date

July 30, 2021

Last Update Submit

April 21, 2026

Conditions

Laparoscopic SurgeryColorectal CancerColorectal DisordersEmergenciesComplication of Surgical ProcedureLong-term Effects of Cancer Treatment

Keywords

Laparoscopic surgeryEmergency surgeryColorectal

Outcome Measures

Primary Outcomes (1)

  • postoperative morbidity

    Postoperative morbidity evaluated by Clavien-Dindo classification

    30 days

Secondary Outcomes (2)

  • Surgical site infections

    30 days

  • Long-term Survival

    5 years

Study Arms (2)

Laparoscopic operation

EXPERIMENTAL

Laparoscopic emergency colon resection

Procedure: Laparoscopic operation

Open operation

ACTIVE COMPARATOR

Open emergency colon resection

Procedure: Open operation

Interventions

Laparoscopic operationPROCEDURE

Operation

Laparoscopic operation
Open operationPROCEDURE

Operation

Open operation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients in need of emergency colon resection

You may not qualify if:

  • age \< 18 year
  • trauma patients
  • reoperations
  • acute pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie Grönroos-Korhonen

Lahti, 15850, Finland

Location

Related Publications (1)

  • 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.

    PMID: 38632602DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsEmergencies

Interventions

Heller Myotomy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomy

Study Officials

  • Marie T Grönroos-Korhonen, MD

    Päijät Häme Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective randomized controlled multicenter trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 13, 2021

Study Start

September 17, 2021

Primary Completion (Estimated)

July 30, 2031

Study Completion (Estimated)

July 30, 2031

Last Updated

April 22, 2026

Record last verified: 2026-02

Locations

FI(1)