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A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.

Phase 3
18 Years
Open (Enrolling)
Rectal Cancer

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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:


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:


Principal Investigator

Jaap Bonjer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dalhousie University, CDHA and VUMC, the Netherlands


Canada: Health Canada

Study ID:




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