C20
Conditions
Interventions
Group 1: Division of the rectum by a linear stapler (one or more magazines 30 mm, 45 mm or 60 mm) followed by a circular stapler rectal anastomosis (28 mm or 31 mm) with an additional omega suture to
Sponsors
Klinikum Nürnberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients scheduled for elective minimally invasive rectal / sigmoid resection with reconstruction via circular stapler rectal anastomosis - Ability of subject to understand character and individual consequences of the clinical trial - Written informed consent - Age =18 years
Exclusion criteria
Exclusion criteria: Preoperative exclusion criteria: - History of left sided colon / rectal surgery - Participation in another interventional trial with interference of intervention and outcome of this trial - American Society of Anesthesiologists (ASA) grade > 3 - Pregnant or lactating women Intraoperative exclusion criteria: - Level of anastomosis of = 4 cm from the dentate line or intersphincteric anastomosis - Anastomosis other than colorectal anastomosis (e.g. ileorectostomy) - Impossibility of circular stapler anastomosis or linear stapler division of the rectum - Conversion to open surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of rectal anastomotic leakages as defined by the International Study Group of Rectal Cancer within the first 90 postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of anastomotic stenosis defined as an anastomotic stricture requiring dilatation 2. Postoperative complications grade = 2 according to the Clavien-Dindo-Classification 3. Intraabdominal abscess 4. Surgical site infection 5. Reoperation 6. 30-day and 90-day mortality 7. Length of primary hospital stay in days from day of operation until day of discharge 8. Operation time 9. Intraoperative blood loss / transfusion | — |
Countries
Germany
Contacts
Public ContactPatrick Heger
Klinikum Nürnberg
Outcome results
None listed