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ISRCTN
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ISRCTN61411448
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ClinicalTrials.gov identifier
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Public title
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Totally laparoscopic versus conventional ileoanal pouch procedure: A randomised controlled trial
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Scientific title
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Acronym
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LapConPouch-Trial
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Serial number at source
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KSC 01/2004
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Proctocolectomy
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2004
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Anticipated end date
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30/09/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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160
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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University of Heidelberg Medical School
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Trial website
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Publications
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Study design on http://www.biomedcentral.com/1471-2482/6/13
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Contact name
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Prof
Markus W
Büchler
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 6221 56 6200
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Fax
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+49 6221 56 6988
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Email
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markus.buechler@med.uni-heidelberg.de
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Sponsor
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University of Heidelberg Medical School (Germany)
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 6221 56 6200
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Fax
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+49 6221 56 6988
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Email
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markus.buechler@med.uni-heidelberg.de
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Date applied
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08/12/2004
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Last edited
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10/10/2007
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Date ISRCTN assigned
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24/01/2005
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