No registrations found.
ID
Source
Health condition
Low anterior resection, anastomotic leakage, anastomotic dehiscence, rectal cancer, surgery
In Dutch: naadlekkage, rectumcarcinoom, laag anterior resectie, chirurgie
Sponsors and support
Intervention
Outcome measures
Primary outcome
To estimate the occurrence of anastomotic leakage when the C-seal is used.
Secondary outcome
1. The assessment of technical feasibility defined as technical success, determined by a gastrografin enema X-ray of the rectum one week after the operation;
2. The successful clearance of the C-seal at 6 weeks without the occurrence of a serious adverse event;
3. Estimation of patient friendliness of the drain, at one week and 6 weeks;
4. Technical success: The Technical success is defined as the successful application of the C-seal;
5. Acute procedural success: Acute procedural success is defined as the successful application of the C-seal without the occurrence of a Serious Adverse Effects (SAE) caused by the drain/protector during or directly after the procedure;
6. Procedural success: The successful placement of the C-seal and the successful clearance of the C-seal with absence of any serious adverse events up to 30 days.
Background summary
Colorectal anastomotic leakage (AL) is a serious complication in colorectal surgery leading to high morbidity and mortality rates. A new device is developed in our institute aimed at protecting the colorectal anastomosis and lowering the incidence of AL. This so called C-seal is a biofragmentable drain, which is stapled to the anastomosis with a circular stapler. It covers the luminal side of the colorectal anastomosis. The C-seal does not prevent the formation of dehiscences. However, it prevents extravasation of faeces into the peritoneal cavity. This means that a gap at the anastomotic site does not lead to leakage.
A pilot study, testing the C-seal in 15 patients, showed that the C-seal can be succesfully applied in colorectal surgery. The C-seal was well compatible with the circular stapler and easy to employ. No anastomotic leakages were observed in these 15 patients.
Study objective
In this phase II study the main objective is the assessment of the occurrence of anastomotic leakage with the use of the C-seal. The assessment will take place one week after the operation, and 6 and 12 weeks after the procedure.
Study design
1. During hospitalisation, 6 weeks and 3 months after surgery: Assessment of end points;
2. One week after surgery: Rectal contrast enema.
Intervention
Placement of the C-seal in a stapled colorectal anastomosis. C-seal is a biofragmentable drain, which is stapled to the anastomosis with a circular stapler. It covers the luminal side of the colorectal anastomosis. The C-seal does not prevent the formation of dehiscences. However, it prevents extravasation of faeces into the peritoneal cavity. This means that a gap at the anastomotic site does not lead to leakage.
A.N. Morks
p/a Secr. Abdominale Chirurgie; BA 11
Groningen 9700 RB
The Netherlands
+31 (0)50 3611294
a.n.morks@chir.umcg.nl
A.N. Morks
p/a Secr. Abdominale Chirurgie; BA 11
Groningen 9700 RB
The Netherlands
+31 (0)50 3611294
a.n.morks@chir.umcg.nl
Inclusion criteria
1. Age > 18 years;
2. The patient requires an anastomosis, maximally 15 cm proximal from the anus;
3. The patient will receive a colorectal anastomosis by means of stapling;
4. The patient is willing and able to comply with the specified follow-up evaluation;
5. The patient must provide written informed consent prior to the procedure.
Exclusion criteria
1. Patient treatment is acute (not elective);
2. Patient is associated with infections at the time of intervention (peritonitis);
3. Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study;
4. Patients with ASA classification > 3.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2178 |
| NTR-old | NTR2302 |
| Other | METc UMCG : 2009.078 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Kolkert JL, Havenga K, ten Cate Hoedemaker HO, Zuidema J, Ploeg RJ. Accepted for publication in American Journal of Surgery.