Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Time to first passage of faeces |
Measured in hours, starting at the skin closure of the index surgery |
From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days |
|
Secondary |
Duration of surgery |
Measured in minutes |
From skin incision to skin closure, during index surgical procedure |
|
Secondary |
Blood loss |
Measured in ml |
From skin incision to skin closure, during index surgical procedure |
|
Secondary |
Intra-operative transfusion |
Number of patients who received blood and/or blood products transfusion |
From skin incision to skin closure, during index surgical procedure |
|
Secondary |
Intra-operative complication |
Number of patients who experienced a complication during the index surgery |
From skin incision to skin closure, during index surgical procedure |
|
Secondary |
Conversion to open surgery |
Number of patients who had conversion to open surgery; defined as an extraction site longer than 10cm |
From skin incision to skin closure, during index surgical procedure |
|
Secondary |
Length of the extraction site |
Measured in centimeters |
At post-operative day 30 |
|
Secondary |
Creation of a stoma |
Number of patients who received a stoma during the index surgery |
From skin incision to skin closure, during index surgical procedure |
|
Secondary |
Hb, WBC and CRP |
Blood tests |
At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5 |
|
Secondary |
Time to first passage of flatus |
Measured in hours, starting at the skin closure of the index surgery |
From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days |
|
Secondary |
In-hospital postoperative ileus |
Number of patients who experienced a post-operative ileus which required the insertion of a nasogastric tube |
During hospitalisation, on average during the first 5 post-operative days |
|
Secondary |
Length of stay |
Measured in days |
From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days |
|
Secondary |
Post-operative morbidity |
Number of patients who experienced post-operative morbidity, as measured by the Clavien-Dindo scale |
From index surgical procedure (skin closure) to post-operative day 30 |
|
Secondary |
Surgical site infection |
Number of patients who experienced surgical site infection |
From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30 |
|
Secondary |
Anastomotic leak |
Number of patients who experienced anastomotic leak, with radiological and/or surgical confirmation |
From index surgical procedure (skin closure) to post-operative day 30 |
|
Secondary |
Re-intervention |
Number of patients who required a surgical re-intervention associated with the index surgery |
From index surgical procedure (skin closure) to post-operative day 30 |
|
Secondary |
Mortality |
Number of patients who experienced mortality |
From index surgical procedure (skin closure) to post-operative day 30 |
|
Secondary |
Proximal margin |
Measured in centimeters, on the operative specimen of the index surgery |
Within 10 days from the index surgical procedure |
|
Secondary |
Distal margin |
Measured in centimeters, on the operative specimen of the index surgery |
Within 10 days from the index surgical procedure |
|
Secondary |
Harvested lymph nodes |
Number of harvested lymph nodes, on the operative specimen of the index surgery |
Within 10 days from the index surgical procedure |
|
Secondary |
Histology of the tumor/polyp |
Type of cancer and/or polyp, based on the operative specimen of the index surgery |
Within 10 days from the index surgical procedure |
|
Secondary |
TNM stage |
8th edition of the UICC TNM classification, based on the operative specimen of the index |
Within 10 days from the index surgical procedure |
|
Secondary |
Bowel function |
Gastrointestinal Quality of Life Index (GQLI) |
At post-operative day 30 and post-operative year 1 |
|
Secondary |
Quality of recovery |
Quality of Recovery-15 (QoR-15) score |
At post-operative hour 12, post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4, post-operative day 5 and post-operative day 7 |
|
Secondary |
Aesthetic numeric analogue scale (ANA-scale) |
Measuring the patient-reported esthetical aspect of the surgical wounds |
At post-operative day 30 and post-operative year 1 |
|
Secondary |
Incidence of incisional hernia |
Overall, and at extraction site; measured clinically and by CT |
At post-operative year 1 |
|