Laparoscopic Approach for Emergency Colon Resection

NCT ID: NCT05005117

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2031-07-30

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective randomized controlled multicenter trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic operation

Laparoscopic emergency colon resection

Group Type EXPERIMENTAL

Laparoscopic operation

Intervention Type PROCEDURE

Operation

Open operation

Open emergency colon resection

Group Type ACTIVE_COMPARATOR

Open operation

Intervention Type PROCEDURE

Operation

Interventions

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Laparoscopic operation

Operation

Intervention Type PROCEDURE

Open operation

Operation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all patients in need of emergency colon resection

Exclusion Criteria

* age \< 18 year
* trauma patients
* reoperations
* acute pancreatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanta-Häme Central Hospital

OTHER_GOV

Sponsor Role collaborator

Joint Authority for Päijät-Häme Social and Health Care

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie T Grönroos-Korhonen, MD

Role: PRINCIPAL_INVESTIGATOR

Päijät Häme Central Hospital

Locations

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Marie Grönroos-Korhonen

Lahti, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Marie Grönroos-Korhonen, MD

Role: CONTACT

0444828049 ext. +358

Jyrki Kössi, adj Prof

Role: CONTACT

0447195218 ext. +358

Facility Contacts

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Marie Grönroos-Korhonen

Role: primary

0444828049

Jyrki Kössi, Doc

Role: backup

+358447195218

References

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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.

Reference Type DERIVED
PMID: 38632602 (View on PubMed)

Other Identifiers

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Q048

Identifier Type: -

Identifier Source: org_study_id

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