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NCT01326065 Clinical Trial

Implementation of Laparoscopy-assisted Surgery for Colon Cancer

Colon Cancer Clinical Trial

Official title:
Implementation of Laparoscopy-assisted Surgery for Colon Cancer. A Prospective Population-based Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01326065
Other study ID # SUH424503
Secondary ID
Status Terminated
Phase N/A
First received February 27, 2011
Last updated May 4, 2017
Start date February 2011
Est. completion date February 2017

Study information
Verified date May 2017
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date February 2017
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Stavanger University Hospital Stavanger

Sponsors (1)
Lead Sponsor Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long term outcome overall survival and cancer specific survival, time to relapse 5 years
Secondary Complications related to the surgical procedure Anastomotic leaks; intra-abdominal infections; extra-abdominal complications, i.e. non-surgical site infections, cardiovascular events, death within 30 days after surgery 30 days
Secondary Quality of life Quality of life as assessed by SF-36 questionary 1 year
Secondary Quality of the surgical specimen R0 resection or not; number of lymph nodes harvested 14 days
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