A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
18 Years
N/A
Both
Rectal Cancer
Trial Information
A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
The design involves allocation of all suitable consecutive patients with rectal carcinoma to
either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic
procedure. Excluded are patients with a carcinoma treated by local resection and palliative
resections. The trial will be stratified according to participating centre, resection type,
and preoperative radiotherapy.
If the 95% CI for the difference of the 3-year locoregional recurrence rates excludes a
difference greater than 5% in favor of the conventional procedure, non-inferiority of the
laparoscopic procedure will be concluded. Assuming both rates are 10%, 1000 evaluable cases
are required in total for a power of 80%.
Analysis will be primarily on an intention to treat basis. Definition of conversion is
defined by protocol.
Inclusion Criteria:
- solitary rectal cancer observed at colonoscopy or on barium X-ray
- no evidence of distant metastases
- distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or
under linea conjugata at lateral barium enema radiography
- suitable for elective surgical resection
- informed consent
Exclusion Criteria:
- T1 tumors treated by locl excision
- T4 tumors
- patients under 18 years of age
- signs of acute intestinal obstruction
- more than one colorectal tumor
- Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
- active crohn's or active ulcerative colitis
- scheduled need for other synchronous colon surgery
- preoperative indication of invasion of adjacent organs, immobile at palpation or CT
showing invasion
- preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
- other malignancies in medical history except adequately treated basocellular
carcinoma of the skin or in situ carcinoma of the cervix uteri
- absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA
class > III)
- pregnancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
locoregional recurrence rate
Outcome Time Frame:
3 years post operatively
Safety Issue:
Yes
Principal Investigator
Jaap Bonjer, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dalhousie University, CDHA and VUMC, the Netherlands
Authority:
Canada: Health Canada
Study ID:
CDHA007
NCT ID:
NCT00297791
Start Date:
June 2004
Completion Date:
October 2017
Related Keywords:
- Rectal Cancer
- rectal cancer
- laparoscopic technique
- open technique
- clinical trial
- multicenter study
- randomized controlled trial
- Tumor Below 15cm
- curative surgical resection
- no evidence for distant metastases
- Rectal Neoplasms
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