Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.lafa-trial.nl

Contact information

Type

Scientific

Primary contact

Dr W.A. Bemelman

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR222; ZonMw reference: 945-06-901

Study information

Scientific title

Acronym

LAFA study

Study hypothesis

That laparoscopic surgery alone or in combination with fast track peri-operative care is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre 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

Laparoscopic surgery

Intervention

Laparoscopic surgery and fast track peri-operative care.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Total post-operative hospital stay including readmission within 30 days
2. Quality of life measured by validated questionnaires (SF-36/Gigli) at two and four weeks after surgery
3. Medical and non-medical costs

Secondary outcome measures

1. Morbidity
2. Patient satisfaction measured by standardised questionnaires
3. Readmission percentage

Overall trial start date

01/07/2005

Overall trial end date

31/12/2008

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

400

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

01/07/2005

Recruitment end date

31/12/2008

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

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

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