rectal cancer sigmoid cancer
Conditions
Interventions
Resection of the rectum or sigmoid colon. Anastomosis by use of a circular
stapler. The anvil of the stapler is placed inside the C-seal. In this wat the
C-seal is stapled to the anastomosis.
If a
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age > 18 years; The patient requires an anastomosis, maximally 15 cm proximal from the anus The patient will receive a colorectal anastomosis by means of stapling; The patient is willing and able to comply with the specified follow-up evaluation; The patient must provide written informed consent prior to the procedure.
Exclusion criteria
Exclusion criteria: Patient treatment is acute (not elective); Patient is associated with infections at the time of intervention (peritonitis); 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; Patients with ASA classification >3;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is recovery of the patient without clinical manifestation of anastomotic leakage. Anastomotic leakage is considered to be clinical manifest if any of the following occurs: * Relaparotomy with dismantling of the anastomosis and creation of an end colostomy * Relaparotomy with placement of drains in the pelvis * Relaparotomy with creation of a diverting ostomy * Radiologically guided drainage of any fluid in the pelvis | — |
Secondary
| Measure | Time frame |
|---|---|
| - The assessment of technical feasibility defined as technical succes, determined by a gastrografin enema X-ray of the rectum (through the C-seal drain) one week after the operation - The successful clearance of the C-seal at 6 weeks without the occurrence of a serious adverse event. - Technical success: The Technical success is defined as the peroperatively successful application of the C-seal. - 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. - Procedural success: The successful placement of the C-seal and the successful clearance at 6 weeks with absence of any serious adverse events up to 30 days. - Concentrations of MMP's, TIMP's, pro-inflammatory en pro-coagulatory factors in blood and tissue samples will be measured. We will determine the relation between their concentrations and the occurence of anastomotic leakage. | — |
Countries
Netherlands
Outcome results
None listed