Condition category
Digestive System
Date applied
14/08/2008
Date assigned
09/10/2008
Last edited
01/02/2012
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

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 measures

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

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

http://www.charite.de/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22290216

Publication citations

  1. 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.

Additional files

Editorial Notes