Anastomotic Leak Rectum, Rectal Cancer
Conditions
Brief summary
Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).
Interventions
In November 2016, the decision to centralize rectal cancer patients to only one surgical unit was taken, with only two surgeons performing the procedures. Furthermore, a close collaboration with local Gastroenterology Units and General Practiotioners was started in order to increase colorectal cancer case referral to our unit. At the same time, we decided to promote the use of laparoscopy and to implement ERAS protocol in our colorectal surgery practice.
Sponsors
Study design
Eligibility
Inclusion criteria
* diagnosis of a cancer located in the rectum, defined according to the international definition by D'Souza et al., * elective setting * anterior rectal resection with primary anastomosis (with or without diverting loop ileostomy).
Exclusion criteria
* age below age of 18, * inflammatory bowel disease, * acquired or congenital immunodeficiency, * preoperative infection, * pregnancy, * ASA IV, * presence of synchronous cancers, * abdominoperineal resection (APR), * failure to perform rectal resection and primary anastomosis, * emergency setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leak | up to 30 days after discharge | rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | up to 30 days after discharge | Rate of any complication after rectal resection |
| Pneumonia | up to 30 days after discharge | rate of radiologically demonstrated pneumonia |
| Ileus | up to 30 days after discharge | rate of any ileus clinically demonstrated |
| Bleeding | up to 30 days after discharge | Rate of any clinically radiologically or endoscopically demonstrated bleeding after rectal resection |
| Reoperation | up to 30 days after discharge | Rate of any reoperation |
| Readmission | up to 90 days after discharge | Rate of any unplanned readmission after discharge |
| Postoperative complications | up to 30 days after discharge | rate of any surgical site infection clinically demonstrated |
| 1-year stoma persistence | up to one year after surgery | rate of stoma persistence |
| Length of hospital stay | up to 30 days after discharge | number of days between primary rectal resection and discharge |
| Use of minimally invasive approach | up to 30 days after discharge | rate of minimally invasive rectal ARR performed |
| Operative time | up to 30 days after discharge | Mean operative time |
| Conversion to open surgery | up to 30 days after discharge | rate of conversion form laparoscopy to one surgery |
| need of postoperative blood transfusion | up to 30 days after discharge | rate of postoperative transfusion |
| 30-days-mortality | up to 30 days after discharge | Rate of any mortality |