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A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer

Phase 3
18 Years
Open (Enrolling)
Colonic Neoplasms

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Trial Information

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer

The design involves allocation of all suitable consecutive patients with colon carcinoma to
either of the two procedures at a randomization ratio of 1:1. The trial will be stratified
according to participating centre, resection type and gender.

Disease free survival for all TNM stages after 3 years is currently about 70%. To detect a
difference of 7% in disease free survival rate after 3 years between open and laparoscopic
resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided
analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). All analyses will be performed on an
intention to treat basis.

Inclusion Criteria:

- Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within
28-days before operation (no biopsy required)

- Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken
within 28 days before operation

- Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy
or sigmoid resection

- Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium

- BMI < 30 kg/m2

- Informed consent according to local requirements

Exclusion Criteria:

- Carcinoma of the splenic flexure

- Carcinoma of the transverse colon

- Signs of acute intestinal obstruction

- More than one colon tumour

- Scheduled need for other synchronous colon surgery

- Synchronous surgery ofr other intra-abdominal organs

- Pre-operative indication of invasion of adjacent organs

- Pre-operative evidence of distant metastases

- Previous ipsilateral colon surgery

- Other malignancies in medical history, except adequately treated basocellular
carcinoma of the skin or in situ carcinoma of the cervix uteri

- Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum,
such as severe cardiovascular or respiratory disease

- Pregnancy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary endpoint is cancer free survival at three years.

Principal Investigator

Jaap Bonjer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dalhousie University, CDHA / Erasmus MC Rotterdam


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

March 1997

Completion Date:

March 2008

Related Keywords:

  • Colonic Neoplasms
  • Neoplasms
  • Colonic Neoplasms