Right-sided Colon Tumor, Laparoscopic Versus Open Surgery, in an ERAS Protocol

February 19, 2015 updated by: Ulf Gustafsson, Karolinska Institutet

Right-sided Colon Tumor, Laparoscopic and Open Surgery, in an ERAS Protocol

Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol.

Hypothesis:

Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 116 91
        • Ersta Hospital
      • Stockholm, Sweden, 182 88
        • Danderyds Hospital
      • Örebro, Sweden, 701 85
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Right sided colom tumor or large benign adenoids

Description

Inclusion Criteria:

  • right-sided colon tumor or large benign adenoids

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Anatomic diagnosis (PAD) on a tumor biopsy
Time Frame: day of surgery

After PAD result, malign or benign tumor, type of malign tumor,tumor growth, stage, lymphatic recharge.

Right selection of patients to laparoscopic versus open surgery in relation to PAD result?
day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay, days
Time Frame: 30 days after surgery
Compare laparoscopic versus open surgery
30 days after surgery
C - reactive protein
Time Frame: 1-7 days after surgery
Inflammation answer laparoscopic versus open surgery
1-7 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immobilizing patient after surgery
Time Frame: 4 -10 hours after surgery
After laparoscopic versus open surgery
4 -10 hours after surgery
Leakage of anastomosis
Time Frame: 0 - 30 days after surgery
Compare laparoscopic versus open surgery
0 - 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Danderyd Hospital
Region Örebro County
Ersta Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/2105-31/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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