Condition category
Digestive System
Date applied
08/12/2004
Date assigned
24/01/2005
Last edited
10/10/2007
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 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

Publication citations

Additional files

Editorial Notes