|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01233713 |
|
Date of registration:
|
02/11/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation
ColonPerfRCT |
|
Scientific title:
|
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial |
|
Date of first enrolment:
|
May 2006 |
|
Target sample size:
|
62 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01233713 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Stefan Breitenstein, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patient age > 18 years
- Left-sided colon perforation
- German language speakers
Exclusion Criteria:
- Patient age < 18 years
- Perforation outside of the left-colon
- Bowel obstruction/disease without perforation
- Evidence of metastasis
Age minimum:
18 Years
Age maximum:
95 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diverticulitis
|
|
Neoplasms
|
|
Postoperative Complications
|
|
Surgery
|
|
Intervention(s)
|
|
Procedure: Hartmann's operation
|
|
Procedure: Primary anastomosis
|
|
Primary Outcome(s)
|
|
Overall post-operative complication rate defined according to the Clavien-Dindo Classification
[Time Frame: 2006 - 2010]
|
|
Secondary Outcome(s)
|
|
In-hospital costs
[Time Frame: 2006 - 2010]
|
|
Length of hospital stay
[Time Frame: 2006 - 2010]
|
|
Length of Intensive Care Unit (ICU) stay
[Time Frame: 2006 - 2010]
|
|
Number of complications for the primary operation
[Time Frame: 2006 - 2010]
|
|
Number of complications for the reversal operation
[Time Frame: 2006 - 2010]
|
|
Operation time
[Time Frame: 2006 - 2010]
|
|
Overall total number of complications
[Time Frame: 2006 - 2010]
|
|
Reversal rate
[Time Frame: 2006 - 2010]
|
|
Serious post-operative complication rate (Clavien-Dindo grade =III) for the primary operation
[Time Frame: 2006 - 2010]
|
|
Serious post-operative complication rate (Clavien-Dindo grade =III) for the reversal operation
[Time Frame: 2006 - 2010]
|
|
Secondary ID(s)
|
|
Colon_Perf_RCT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|