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Laparoscopic Approach for Emergency Colon Resection

Primary Purpose

Laparoscopic Surgery, Colorectal Cancer, Colorectal Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Laparoscopic operation
Open operation
Sponsored by
Joint Authority for Päijät-Häme Social and Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Surgery focused on measuring Laparoscopic surgery, Emergency surgery, Colorectal

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients in need of emergency colon resection

Exclusion Criteria:

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

Sites / Locations

  • Marie Grönroos-KorhonenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic operation

Open operation

Arm Description

Laparoscopic emergency colon resection

Open emergency colon resection

Outcomes

Primary Outcome Measures

postoperative morbidity
Postoperative morbidity evaluated by Clavien-Dindo classification

Secondary Outcome Measures

Surgical site infections
Surgical site infections, superficial and deep
Long-term Survival
Long-term overall and cancer-specific survival

Full Information

First Posted
July 30, 2021
Last Updated
August 4, 2023
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Kanta-Häme Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05005117
Brief Title
Laparoscopic Approach for Emergency Colon Resection
Official Title
Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
July 30, 2031 (Anticipated)
Study Completion Date
July 30, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Kanta-Häme Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Surgery, Colorectal Cancer, Colorectal Disorders, Emergencies, Complication of Surgical Procedure, Long-term Effects of Cancer Treatment
Keywords
Laparoscopic surgery, Emergency surgery, Colorectal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective randomized controlled multicenter trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic operation
Arm Type
Experimental
Arm Description
Laparoscopic emergency colon resection
Arm Title
Open operation
Arm Type
Active Comparator
Arm Description
Open emergency colon resection
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic operation
Intervention Description
Operation
Intervention Type
Procedure
Intervention Name(s)
Open operation
Intervention Description
Operation
Primary Outcome Measure Information:
Title
postoperative morbidity
Description
Postoperative morbidity evaluated by Clavien-Dindo classification
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Surgical site infections
Description
Surgical site infections, superficial and deep
Time Frame
30 days
Title
Long-term Survival
Description
Long-term overall and cancer-specific survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients in need of emergency colon resection Exclusion Criteria: age < 18 year trauma patients reoperations acute pancreatitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Grönroos-Korhonen, MD
Phone
0444828049
Ext
+358
Email
marie.gronroos-korhonen@phhyky.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jyrki Kössi, adj Prof
Phone
0447195218
Ext
+358
Email
jyrki.kossi@phhyky.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie T Grönroos-Korhonen, MD
Organizational Affiliation
Päijät Häme Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marie Grönroos-Korhonen
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Grönroos-Korhonen
Phone
0444828049
Email
marie.gronroos-korhonen@phhyky.fi
First Name & Middle Initial & Last Name & Degree
Jyrki Kössi, Doc
Phone
+358447195218
Email
jyrki.kossi@paijatha.fi

12. IPD Sharing Statement

Learn more about this trial

Laparoscopic Approach for Emergency Colon Resection

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