Contact information
Type
Scientific
Primary contact
Prof Heinz J. Buhr
ORCID ID
Contact details
Charite - Universitatsmedizin Berlin
Campus Benjamin Franklin
Department of General
Vascular and Thoracic Surgery
Hindenburgdamm 30
Berlin
12200
Germany
+49 (0)30 8445 2543
heinz.buhr@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LATEND trial
Study hypothesis
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
Local Medical Ethics Committee gave approval on the 20th October 2005
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/02/2006
Overall trial end date
31/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
224
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
31/10/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Charite - Universitatsmedizin Berlin
Berlin
12200
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Campus Benjamin Franklin
Department of General
Vascular and Thoracic Surgery
Hindenburgdamm 30
Berlin
12200
Germany
+49 (0)30 8445 2543
heinz.buhr@charite.de
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany) - Department of General, Vascular and Thoracic Surgery, Campus Benjamin Franklin
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GAST-study group (Germany)
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22290216
Publication citations
-
Results
Zurbuchen U, Kroesen AJ, Knebel P, Betzler MH, Becker H, Bruch HP, Senninger N, Post S, Buhr HJ, Ritz JP, , Complications after end-to-end vs. side-to-side anastomosis in ileocecal Crohn's disease--early postoperative results from a randomized controlled multi-center trial (ISRCTN-45665492)., Langenbecks Arch Surg, 2013, 398, 3, 467-474, doi: 10.1007/s00423-012-0904-1.