Influence of laparoscopy and/or fast-track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care

ISRCTN	ISRCTN26698501
DOI	https://doi.org/10.1186/ISRCTN26698501
Protocol serial number	NTR276
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Internal funding

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

Dr J. Wind
Scientific

Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5663170
Email	J.Wind@amc.uva.nl

Primary study design	Interventional
Study design	Randomised, double-blind, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TRANSIT-study
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Gastrointestinal transit
Key secondary outcome measure(s)	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
Completion date	01/07/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
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 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
Date of first enrolment	01/09/2005
Date of final enrolment	01/07/2007

Academic Medical Centre

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan