None listed
Conditions
Interventions
Comparing Laparoscopic and Conventional Open Surgical Treatment of Colon Cancer
Sponsors
Philip Bagshaw
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participating surgeons are free, however, to us their own discretion in deciding whether to offer entry to apparently eligible patients.To be eligible patients must meet all of the following criteria: must have the clinical diagnosis* of a single adenocarcinoma of the ascending (defined as from ileocaecal valve up to and including hepatic flexure), descending (defined as from splenic flexure to junction with sigmoid colon), or sigmoid colon (defined as between descending colon and rectum (at least 15 cm from dentateline) based on the following considerations:physical examination, and colonoscopy or sigmoidoscopy plus barium enema. 18 years of age or older and able to give informed consent. must be able to participate in follow-up evaluations. must not have prohibitive scars/adhesions from previous abdominal surgery (surgeon's discretion).*[DSMB requires standard follow-up irrespective of final pathology].
Exclusion criteria
Any of the following will result in exclusion: advanced local disease, defined as >8cm in diameter or extensive infiltration of adjacent structures, rendering laparoscopic resection not possible (based on clinical examination or preoperative imaging). Dukes'D disease (based on preoperative studies).** rectal cancer (below peritoneal reflection, lower edge of tumour <1 5cm from dentate line as measured by the designated Study Surgeon, using rigid sigmoidoscopy). emergency presentations of colon cancer such as obstruction, perforation ormassive bleeding. transverse colon cancer (defined as between distal hepatic flexure and proximalsplenic flexure). morbid obesity (defined as body mass >35 [weight in kg ¸ height in metresquared]). ASA IV: severe, incapacitating disease. ASA V: imminent danger of death. Associated gastrointestinal diseases that require additional extensive operative evaluation or intervention (e.g. inflammatory bowel disease, familial polyposis). pregnancy. any current or previous malignant tumour (within the previous 5 years) exceptsuperficial squamous or basal cell carcinoma of the skin, or in situ cancer of thecervix.**[In Australia, Dukes' D patients are included as a separate study group. Patients diagnosed preoperatively with disseminated colon cancer, who require resection of the colonic primary for symptomatic relief, will be randomised to colonic resection by laparotomy or laparoscopic assisted technique].
Outcome results
None listed