Implementation of Laparoscopy-assisted Surgery for Colon Cancer

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01326065

Enrollment

Registered

2011-03-30

Start date

2011-02-28

Completion date

2017-02-28

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Long term outcome	5 years	overall survival and cancer specific survival, time to relapse

Secondary

Measure	Time frame	Description
Complications related to the surgical procedure	30 days	Anastomotic leaks; intra-abdominal infections; extra-abdominal complications, i.e. non-surgical site infections, cardiovascular events, death within 30 days after surgery
Quality of life	1 year	Quality of life as assessed by SF-36 questionary
Quality of the surgical specimen	14 days	R0 resection or not; number of lymph nodes harvested

Countries

Norway

Outcome results