Status:
UNKNOWN
Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer
Lead Sponsor:
The Queen Elizabeth Hospital
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Health Research Council, New Zealand
Conditions:
Colonic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the short and long term outcomes of people who have colon cancers removed either by laparotomy (a large cut in the abdominal wall) or by a laparoscopic assisted...
Detailed Description
AIMS The primary aim of the study is to test the hypothesis that tumour related disease free interval and overall survival are equivalent regardless whether patients receive laparoscopic colon resect...
Eligibility Criteria
Inclusion
- Clinical diagnosis of a single adenocarcinoma of the ascending, descending, or sigmoid colon
- 18 years of age or older
- Able to give informed consent
- Must be able to participate in follow-up examinations
- Must not have prohibitive scars or adhesions from previous abdominal surgery
Exclusion
- Advanced local disease, defined as \>8cm in diameter or extensive infiltration
- Any previous or current malignant tumour with the previous 5 years (except superficial squamous or basal cell skin carcinoma or in situ cervical cancer)
- ASA 4
- ASA 5
- Associated gastrointestinal disease
- Dukes D disease
- Emergency presentation
- Massive bleeding
- Morbid obesity
- Pregnancy
- Rectal cancer
- Transverse colon cancer
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
End Date :
March 1 2010
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00202111
Start Date
January 1 1998
End Date
March 1 2010
Last Update
October 17 2006
Active Locations (20)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Concord Hospital
Concord, New South Wales, Australia, 2137
3
St George Hospital
Kogarah, New South Wales, Australia, 2217
4
Royal North Shore Hospital & Community Health Service
St Leonards, New South Wales, Australia, 2065