Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Wind

ORCID ID

Contact details

Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663170
J.Wind@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR276

Study information

Scientific title

Acronym

TRANSIT-study

Study hypothesis

That minimal invasive laparoscopic surgery and/or multimodal patient care (fast-track) can prevent post-operative ileus and/or improve post-surgical gastrointestinal motility compared to open surgery and/or conventional patient care.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, double-blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Colorectal cancer

Intervention

Laparoscopic surgery and fast-track peri-operative care. At the start and at the end of the surgical procedure peritoneal lavage fluid and blood samples are collected. Cytokine levels in these samples will be determined and cells will be isolated. 24 hours post-operative a labeled test-meal will be administered orally. Abdominal scans will be made 2, 24 and 48 hours after intake of the test-meal.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Gastrointestinal transit

Secondary outcome measures

1. Clinical evaluation (passage of first stool, passage of first flatus, time till normal oral food-intake, time till discharge)
2. Intra-abdominal inflammatory status

Overall trial start date

01/09/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Prior midline laparotomy
2. American Society of Anaesthesiologists (ASA) grade IV
3. Laparoscopic surgeon not available
4. Prior upper and/or lower midline laparotomy
5. Emergency colectomy
6. Contraindications for epidural (coagulation disorders)
7. Planned stoma

Recruitment start date

01/09/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Other

Funder name

Internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes