Relevance of circulating tumour cells in patients undergoing laparoscopic colon resection versus open resection: a randomised trial
| ISRCTN | ISRCTN28212149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28212149 |
| Protocol serial number | NTR277 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Internal funding |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Wind
Scientific
Scientific
Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5663170 |
|---|---|
| J.Wind@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CTC-trial |
| Study objectives | We hypothesise that free circulating tumour cells can be detected during surgery in patients with colorectal cancer. Since minimal invasive surgery causes less trauma and tumour manipulations we hypothesise that the amount of free circulating tumour cells is less compared to the level detected during open surgery in comparable patient groups. Minimal invasive surgery causes less severe impairment of the immune system compared to open surgery. Since the surgical trauma might enhance tumour shedding and compromises immune function, the minimally invasive surgery for colorectal cancer might both lower the risk of tumour shedding and result in less compromised immune down-regulation resulting in better protection against tumour shedding. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | Laparoscopic surgery compared to open surgery for colorectal cancer. |
| Intervention type | Other |
| Primary outcome measure(s) |
The amount of circulating tumour material induced by the surgical procedure, measured before, during and after the surgical procedure. |
| Key secondary outcome measure(s) |
1. The level of cytokines before, during and after the surgical procedure |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Aged between 40 and 80 years 2. Colorectal cancer including colon and rectosigmoid cancers 3. Informed consent |
| Key exclusion criteria | 1. Prior midline laparotomy 2. American Society of Anaesthesiologists (ASA) grade III/IV 3. Laparoscopic surgeon not available 4. Prior upper and/or lower midline laparotomy 5. Emergency colectomy 6. Contraindications for epidural (coagulation disorders) |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
