NCT01326065

Brief Summary

The purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

February 27, 2011

Last Update Submit

May 4, 2017

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Long term outcome

    overall survival and cancer specific survival, time to relapse

    5 years

Secondary Outcomes (3)

  • Complications related to the surgical procedure

    30 days

  • Quality of life

    1 year

  • Quality of the surgical specimen

    14 days

Eligibility Criteria

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

All patients submitted for curative resection of colon cancer to the Dept. of Surgery, Stavanger University Hospital. Catchment area of the hospital consists of a population of 300.000 inhabitants, with Stavanger UH as the only institution with surgical service

You may qualify if:

  • Age \>17 years
  • diagnosis of colon cancer either endoscopically, radiologically or histologically proven
  • No evidence of disseminated disease on CT scan
  • T1-3 according to preoperative CT scan
  • written informed consent to participate

You may not qualify if:

  • preoperative diagnosis of locally advanced tumor (T4)
  • suspicion of pathological lymph nodes outside anticipated resection area
  • contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
  • lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, N-4020, Norway

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hartwig Kørner, MD PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

  • Jens Christian Knapp, MD

    Helse Stavanger HF

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2011

First Posted

March 30, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2012

Study Completion

February 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)