Influence of latero-lateral versus end-to-end ileo-ascendostomy on recurrence and complications after ileocaecal resection in patients with Crohn's disease

ISRCTN	ISRCTN45665492
DOI	https://doi.org/10.1186/ISRCTN45665492
Secondary identifying numbers	N/A

Submission date: 14/08/2008
Registration date: 09/10/2008
Last edited: 01/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Heinz J. Buhr
Scientific

Charite - Universitatsmedizin Berlin
Campus Benjamin Franklin
Department of General, Vascular and Thoracic Surgery
Hindenburgdamm 30
Berlin
12200
Germany

Phone	+49 (0)30 8445 2543
Email	heinz.buhr@charite.de

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	LATEND trial
Study objectives	An important problem after surgical resection of Crohn's disease remains the high risk of recurrence. The anastomosis region is the most common localisation for recurrence and may lead to prompt reoperation. The configuration of the anastomosis is an often discussed reason for this phenomena. Wide stapled latero-lateral anastomoses appear to provide fewer relapses due to a reduced risk of re-stenosis than conventional sutured end-to-end-anastomosis, on the other hand there seems to be an increased risk of fistulas after stapled anastomosis. The existing literature on this topic has several essential deficits thus reducing their validity. Therefore a randomised controlled multicentre trial under standardised conditions is necessary to achieve a high validity to investigate the influence of latero-lateral versus end-to-end ileo-ascendostomy on recurrence and complications after ileocaecal resection in patients with Crohn's disease.
Ethics approval(s)	Local Medical Ethics Committee gave approval on the 20th October 2005
Health condition(s) or problem(s) studied	Crohn's disease
Intervention	Group one: ileocaecal resection with conventional sutured end-to-end ileo-ascendostomy Group two: ileocaecal resection with stapled latero-lateral ileo-ascendostomy The total duration of follow-up for both treatment arms is 3 years.
Intervention type	Other
Primary outcome measure	Endoscopic proven perianastomotic relapse of bowel inflammation one year after surgical resection (using an endoscopic relapse score).
Secondary outcome measures	1. Endoscopic proven perianastomotic relapse of bowel inflammation three years after surgical resection (using an endoscopic relapse score): one and three years after randomisation 2. Symptomatic perianastomotic relapse (diarrhoea, pain, fever, weight reduction, increasing inflammation parameters in blood): one and three years after randomisation 3. Relapse with indication for surgical resection: one and three years after randomisation 4. Anastomotic leaks: day of discharge from the hospital
Overall study start date	01/02/2006
Completion date	31/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	224
Key inclusion criteria	1. Aged greater than or equal to 18 years, either sex 2. Ileal stenosis or stricture due to Crohn's disease with indication for ileocaecal resection or right hemicolectomy 3. First perianastomotic relapse of bowel inflammation with indication for surgical resection
Key exclusion criteria	1. Other intestinal inflammation due to Crohn's disease 2. Aged less than 18 years 3. Pregnancy 4. Given or assumed indication for post-operative medication with azathioprine 5. Impossibility of post-operative dose reduction for cortisone medication
Date of first enrolment	01/02/2006
Date of final enrolment	31/10/2009

Locations

Countries of recruitment

Germany

Study participating centre

Charite - Universitatsmedizin Berlin

Berlin
12200
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education

Campus Benjamin Franklin
Department of General, Vascular and Thoracic Surgery
Hindenburgdamm 30
Berlin
12200
Germany

Phone	+49 (0)30 8445 2543
Email	heinz.buhr@charite.de
Website	http://www.charite.de/
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany) - Department of General, Vascular and Thoracic Surgery, Campus Benjamin Franklin

No information available

GAST-study group (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2013		Yes	No