Totally laparoscopic versus conventional ileoanal pouch procedure: A randomised controlled trial
| ISRCTN | ISRCTN61411448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61411448 |
| Secondary identifying numbers | KSC 01/2004 |
- Submission date
- 08/12/2004
- Registration date
- 24/01/2005
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Markus W Büchler
Scientific
Scientific
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 6221 56 6200 |
|---|---|
| markus.buechler@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Totally laparoscopic versus conventional ileoanal pouch procedure: A randomised controlled trial |
| Study acronym | LapConPouch-Trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/09/2004 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 160 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Heidelberg University
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Heidelberg
69120
Germany
Sponsor information
University of Heidelberg Medical School (Germany)
University/education
University/education
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 6221 56 6200 |
|---|---|
| markus.buechler@med.uni-heidelberg.de | |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
University/education
University of Heidelberg Medical School
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/11/2006 | Yes | No | |
| Results article | results | 01/08/2013 | Yes | No |
Editorial Notes
04/10/2017: Publication reference added.
