| 1. |
|
|
| 2. |
|
|
| 3. |
- Buunen, M, et al.
(author)
-
COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.
- 2009
-
In: Danish medical bulletin. - 1603-9629 .- 0907-8916. ; 56:2, s. 89-91
-
Journal article (peer-reviewed)abstract
- INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).
|
|
| 4. |
|
|
| 5. |
- D'Hoore, A., et al.
(author)
-
COMPRES : a prospective postmarketing evaluation of the compression anastomosis ring CAR 27/ColonRing
- 2015
-
In: Colorectal Disease. - : Wiley. - 1462-8910 .- 1463-1318. ; 17:6, s. 522-529
-
Journal article (peer-reviewed)abstract
- AimPreclinical studies have suggested that nitinol-based compression anastomosis might be a viable solution to anastomotic leak following low anterior resection. A prospective multicentre open label study was therefore designed to evaluate the performance of the ColonRing in (low) colorectal anastomosis. MethodThe primary outcome measure was anastomotic leakage. Patients were recruited at 13 different colorectal surgical units in Europe, the United States and Israel. Institutional review board approval was obtained. ResultsBetween 21 March 2010 and 3 August 2011, 266 patients completed the study protocol. The overall anastomotic leakage rate was 5.3% for all anastomoses, including a rate of 3.1% for low anastomoses. Septic anastomotic complications occurred in 8.3% of all anastomoses and 8.2% of low anastomoses. ConclusionNitinol compression anastomosis is safe, effective and easy to use and may offer an advantage for low colorectal anastomosis. A prospective randomized trial comparing ColonRing with conventional stapling is needed.
|
|
| 6. |
|
|
| 7. |
|
|
| 8. |
- D'Hoore, A., et al.
(author)
-
Circular 'superelastic' compression anastomosis : from the animal lab to clinical practice
- 2008
-
In: MITAT. Minimally invasive therapy & allied technologies. - : Informa UK Limited. - 1364-5706 .- 1365-2931. ; 17:3, s. 172-5
-
Journal article (peer-reviewed)abstract
- The recent development of a compression device using shape memory Nitinol technology to create an end-to-end anastomosis has renewed the interest in sutureless anastomotic techniques. A phase II, prospective open label clinical trial was started in May 2007 to evaluate the feasibility and safety of this new anastomotic device. Fourty patients who need left colectomy or high anterior resection for either diverticular disease or adenocarcinoma will be recruited in two academic hospitals (Uppsala,Sweden and Leuven, Belgium). Clinical leakage is the primary endpoint. Only preliminary results are available to date as the recruitment is ongoing. The median age of the first ten patients is 57.5 years (44-72). No anastomotic leakage occurred. The median hospital stay was 4.0 days. Only three patients noticed the passage of the ring through the anal canal. By three weeks no ring was sustained in the gastrointestinal tract as was objectified by plain X-ray. First clinical use of this new anastomotic device seems promising. Final results for the total phase II trial are awaited. A prospective randomized trial to compare the efficacy of the EndoCar 28 with conventional stapling should be the next step.
|
|
| 9. |
|
|
