Contact information
Type
Scientific
Primary contact
Prof Markus W Büchler
ORCID ID
Contact details
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
markus.buechler@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KSC 01/2004
Study information
Scientific title
Acronym
LapConPouch-Trial
Study hypothesis
Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study. The trial will answer the question whether there is indeed an advantage in the laparoscopic group in regard to blood loss and the need for blood transfusions. Moreover, it will generate data on the safety and potential advantages and disadvantages of the minimally invasive approach.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Proctocolectomy
Intervention
This is an intra-operatively randomised, controlled single centre trial of patients with familial polyposis (FAP) or ulcerative colitis (UC) who undergo primary elective restorative proctocolectomy. It is designed as a two-group parallel superiority study. The randomisation will be performed after induction of anaesthesia. The pre and postoperative treatment and assessment is kept equal in both groups to minimise bias.
80 laparoscopic versus 80 conventional ileoanal pouch.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary objective of this study is to compare the totally laparoscopic with the conventional approach in regard to intraoperative blood loss and need for perioperative blood transfusions (within first 24 hours after surgery). We hypothesise that intraoperative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group.
Secondary outcome measures
A set of surgical and non-surgical parameters related to the operation will be analysed as secondary objectives. These will include operative time, complications, postoperative pain, lung function, postoperative length of hospital stay, a cosmetic score and pre-and postoperative quality of life. Moreover an appraisal of patients as well as of physicians concerning the relevance of various outcome parameters will be evaluated as part of an additional scientific project in order to create a basis for further relevant research questions.
Overall trial start date
01/09/2004
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Hospitalised patients of the Department of General surgery, Visceral surgery, Trauma surgery and Outpatient Clinic of the University of Heidelberg, Medical School, who are planned for an elective restorative proctocolectomy either for familial polyposis or for ulcerative colitis. 160 patients (80 laparoscopic vs 80 conventional ileoanal pouch) will be enrolled in order to recruit the 65 evaluable patients per group for the primary endpoint.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
160
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2004
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Sponsor information
Organisation
University of Heidelberg Medical School (Germany)
Sponsor details
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
markus.buechler@med.uni-heidelberg.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Heidelberg Medical School
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
Study design on http://www.biomedcentral.com/1471-2482/6/13