NCT01831245

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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 Start

First participant enrolled

January 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

3.5 years

First QC Date

February 25, 2013

Last Update Submit

February 19, 2015

Conditions

Colon Tumor

Outcome Measures

Primary Outcomes (1)

  • Pathological Anatomic diagnosis (PAD) on a tumor biopsy

    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 Outcomes (2)

  • Length of hospital stay, days

    30 days after surgery

  • C - reactive protein

    1-7 days after surgery

Other Outcomes (2)

  • Immobilizing patient after surgery

    4 -10 hours after surgery

  • Leakage of anastomosis

    0 - 30 days after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Right sided colom tumor or large benign adenoids

You may qualify if:

  • right-sided colon tumor or large benign adenoids

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Örebro University Hospital

Örebro, 701 85, Sweden

Location

Ersta Hospital

Stockholm, 116 91, Sweden

Location

Danderyds Hospital

Stockholm, 182 88, Sweden

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ulf Gustafsson, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 25, 2013

First Posted

April 15, 2013

Study Start

January 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

SE(3)